Clinical Affairs Resume Sample
Thea Miller
581 Donnelly Burgs,
Detroit,
MI
+1 (555) 357 6878
Work Experience
Clinical Affairs Manager
12/2015
-
PRESENT
New York, NY
- Load and maintain study documents in Bard’s eTMF (electronic Trial Master File)
- Update and maintain Bard’s Clinical Trial Management System (CTMS) for assigned studies to ensure accurate tracking of study contacts, vendor contacts and expiring study documents
- Coordinate the reporting and follow-up of reportable adverse events to Bard’s field assurance team
- Strong computer skills with experience in Microsoft Outlook, Word, Excel, Access, Project and PowerPoint, and the ability to quickly learn and navigate Bard’s internal network systems (e.g., CTMS, SharePoint, etc.)
- Participate in and leads multi-disciplinary project teams (including consultants and vendors) to coordinate all aspects of clinical study execution including site identification and start-up, clinical product availability, Trial Master File maintenance, routine monitoring, and study close-out..
- Strong working knowledge of Good Clinical Practices (GCP), FDA regulations, and current industry practices related to the conduct of clinical trials
- Plays a primary role in identifying key opinion leader(s)/principle investigators for the program to ensure adequacy of the program’s scientific basis and obtain endorsement on the assumptions related to medical needs and clinical utility represented in the project development strategy
- Supervises and coordinates clinical monitors workload within a project, as required
- Plans and initiates the steps involved in the clinical research process; in conjunction with the clinical project leader, manages all aspects of a project in accordance with established timelines, applicable project standards and standard operating procedures
Clinical Affairs Coordinator
02/2010
-
06/2015
Dallas, TX
- Directs data collection, analyses and communication of clinical research results, in accordance with applicable regulations, and in support of strategic business and/or regulatory goals
- Hires, develops, trains, mentors and retains senior clinical operations staff, study managers and contractors who demonstrate a high level of professionalism, excellence and competency
- Responsible for financial management oversight of department and clinical trial program budgets, contract negotiations and budgets with clinical study sites and vendors. Provides proactive management of resource allocation, personnel and budgets
- Oversees work with external vendors, IS/IT/Training platforms to develop Clinical systems and tools that promote compliant, expedient data collection, analyses, reporting and deliverables. Seeking e-tools to promote transparency and accountability for all clinical programs (e.g. Executive Dashboard)
- Ensures that all Clinical Operations staff and vendors have adequate GCP training. Ensures Clinical team compliance with requirements for corporate training and continuing education
- Anticipates/identifies potential problems and implements corrective actions as required for clinical study activities. Ensure audit readiness at all times (Sponsor and Investigational Study Sites). Participates in internal/external study-related audits, as required
- Represents Getinge and the ACT Team at conferences, regulatory meetings, and relevant society meetings and trade associations
- Demonstrated experience to effectively manage projects, independently solve problems and deliver high quality, compliant clinical research results
Administrative Assistant, Clinical Affairs
03/2003
-
01/2010
Dallas, TX
- Demonstrated expertise and strong understanding of the overall project goals, the indication(s) studied and the purpose of the planned studies in meeting the objectives of the project
- Supervises and coordinates clinical monitors workload within a project, as required; Plans and initiates the steps involved in the clinical research process; manages all aspects of a project in accordance with established timelines, applicable regulations and standards, and standard operating procedures
- Provides strategic direction regarding the evaluation, design, resource allocation and execution of physician-initiated investigations (Investigator Initiated Studies). Clinical Operations is the administrator of the IIS Committee activities to review, document, implement and track all Getinge IIS proposals
- Provides management and oversight of activities by Clinical Operations to support the risk benefit analyses as part of the Quality System, product lifecycle and Risk Management requirements. As required, responsible author of clinical literature evaluation reports (e.g., Clinical Risk Benefit Analysis – CRBAs, Clinical Evaluation Reports – CERs, Overall Risk Benefit Analyses – ORBAs)
- Member of the Quality Management Review Committees/Teams representing Clinical Affairs with responsibility assigned according to the Management Review SOPs; responsible as Clinical Affairs sign-off of related Quality Management System Controlled Documents
- Interfaces and collaborates with Regulatory Department as necessary to develop responses to Health Authority (e.g., FDA) and Notified Body queries, requests for information, submissions in support of ongoing Getinge product registrations and CE marking requirements
- Reviews and approves study documentation for clinical programs including: protocols, statistical and data analysis plans, monitoring plans, informed consent forms, case report forms, investigator agreements and financial agreements, as required
- Continues to increase knowledge of medical device development processes and standards set forth in FDA regulations, ICH-GCP guidelines, ISO, MEDDEV guidelines, and any other applicable local/international regulatory requirements
- Interfaces with Medical Affairs, Legal, R&D, Regulatory, and Marketing to ensure that clinical activities are in line with overall product development goals. Participates in cross-functional meetings. Provides clinical updates and strategy considerations to Chief Strategic Officer, Chief Technology Officer and other senior management members, as required
Education
University of Mount Union
1999 - 2003
Bachelor's Degree in Health
Professional Skills
- Leadership skills to effectively communicate vision, strategy and goals; leading and inspiring others to support and achieve the aligned goals
- High level, professional communication skills with a wide variety of people; experience in communicating with outside regulatory bodies such as the FDA
- Strong interpersonal skills including communication, collaboration and negotiation capabilities
- Understand clinical trial scoping and developing clinical trial documents, fostering medical writing skills
- Fifteen years or more of relevant clinical research experience and/or combination of education and related experience is necessary
- Leadership experience, with proven track record of delivering projects on time and promoting high performance behaviors within a team
- Prior experience working with cross-functional project teams, IRBs and business partners
How to write Clinical Affairs Resume
Clinical Affairs role is responsible for clinical, interpersonal, presentation, organizational, software, design, microsoft, leadership, negotiation, medical.
To write great resume for clinical affairs job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Clinical Affairs Resume
The section contact information is important in your clinical affairs resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Clinical Affairs Resume
The section work experience is an essential part of your clinical affairs resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous clinical affairs responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular clinical affairs position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Clinical Affairs resume experience can include:
- Strong proofreading/editing skills for reviewing policies, procedures, and guidelines
- Excellent communication, teaching and presentation skills
- Strong organizational skills to manage, track, and report on various areas related to Clinical Operations and Quality and Patient Safety
- Proven leadership skills and ability to work seamlessly in a matrix environment
- Effectively supervises, delegates, assists, and advises Clinical Research Associates monitoring clinical studies, including contracted Associates
- Management experience, with proven track record of delivering projects on time and promoting high performance behaviors within a team
Education on a Clinical Affairs Resume
Make sure to make education a priority on your clinical affairs resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your clinical affairs experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Clinical Affairs Resume
When listing skills on your clinical affairs resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical clinical affairs skills:
- Strong interpersonal, organizational and communication skills, both written and oral
- Effectively oversees, supervises, directs, delegates, assists, and advises Clinical Research Associates monitoring clinical outcomes studies
- Customer service skills and a commitment to service quality
- Experience in rheumatology, immunology, gastroenterology or pathology is strongly desired
- Demonstrated ability to operate independently, to take initiative, be resourceful, and exercise astute clinical judgment to drive performance
- Understand and implement statistical management concepts using big data sets, and gain experience on developing the clinical relevance behind the results
List of Typical Experience For a Clinical Affairs Resume
1
Experience For Clinical Affairs Manager Resume
- Good organizational and computer skills. Ability to pick up new software tools easily
- Experienced in collaboration and effective interface at the senior management level
- Strength in analytical, interpersonal and organizational skills. Attention to detail and ability to multi-task in a fast-paced environment
- Demonstrates problem-solving strategies, developing alternative solutions and contingencies to address issues as they occur
- Partner with MKT, GCA operations, HCER on evidence plan, podium strategy, study design/execution, and scientific communications
2
Experience For Clinical Affairs Specialist Resume
- Proven track record of delivering results, with specific emphasis on drug/device approvals and/or clearances
- Independently set and manage multiple competing priorities while guiding others
- Successful track record for hiring, managing and developing clinical research professionals
- Reports documentation and coding discrepancy trends to the Regional Director of OASIS and Coding
- Assists in relaying or obtaining information for data entry, if applicable
- Maintains current knowledge of issues and changes in Medicare/Intermediary requirements significant to coding, Oasis, and billing accuracy
- Assist in the development of clinical study documents, including clinical trial protocols and electronic data capture (EDC) case report forms
- Travel, including internationally up to 20-40% of the time
3
Experience For Clinical Affairs Coordinator Resume
- Applies best practices and the team’s talents to add value to the business, through successfully managing the completion and execution of projects and driving learning and improvements
- Results oriented with focus on achieving SBU business objectives
- Motivate, enthuse and build respect
- Pre-plan and execute on- or off-site customer/physician meetings
- Collaborate with Human Resources to facilitate interview schedules for department positions
- Occasionally assist with VP’s personal appointments and travel to integrate seamlessly with business needs
- Interact professionally with all levels of Edwards employees, customers, vendors, and stakeholders
- Helps to manage the use of 3rd party Clinical Research Organizations (CRO’s) and other related contractors
- Prepare and report on the status of clinical investigations internally and externally
4
Experience For Head of Clinical Affairs Resume
- Deep familiarity with the practice of medicine, medical terminology and clinical workflows, including medical imaging diagnostics, pathology, and clinical laboratory medicine
- Develop standards to identify, engage and evaluate mutually beneficial relationships with external stakeholders (physicians, scientific experts, educators and investigators) for educational and clinical research partnerships ensuring alignment with strategic objectives
- Understand and effectively communicate current scientific knowledge related to Hologic’s products with external customers
- BA/BS in life science or equivalent combination of education and experience
- Lead and manage Clinical Development and Utilization Management Colleagues Develop and drive clinical strategy
- Oversee and manage Custom Criteria Development, including building and documenting the supporting business processes and ensuring alignment with standard benefits configuration best practices
- Establish and document clinical intent of programs, edits and UM policies to support benefit coding and testing activities - Provide clinical subject matter expertise and support for internal and external customers interfacing cross-functionally to reach consensus on clinically related matters
- Coordinate and ensure accurate implementation and maintenance of the utilization management edits across all lines of business
- Participate on cross-functional teams and coordinate MA clinical contributions
5
Experience For Senior Specialist, Clinical Affairs Resume
- Oversee Policy and Procedure development and maintenance
- Review individual plans and product offerings to determine medication drivers and trends, demographics, identifying areas of opportunity to appropriately apply and/or remove UM edits
- Support Product Development and Management, Audit Activities, Key Strategic initiatives and Task Forces, Clinical Quality, Clinical Operations, Benefits/Clinical Client Operations and Sales, Account Management and Clinical Advisors
- Participate in the interpretation of data from current clinical studies and/or performing statistical analysis on big data sets for potential poster or publication efforts
- Participate in clinical trial scoping, including literature searches and appraisal clinical literature to support clinical study scoping and
6
Experience For Administrative Assistant, Clinical Affairs Resume
- Work to develop presentations for internal/external stakeholders for Clinical Affairs activities
- Manages and/or oversees all study related tasks for assigned Zimmer Biomet Spine clinical studies
- Prepares, oversees, and reviews the preparation of clinical documents, e.g., protocols, investigator brochure, annual report updates, case report forms and clinical study reports, monitoring plans, and budgets
- Manages administrative aspects of a clinical project/study including, training, study initiation, trial maintenance, data monitoring, data reporting, vendor selection and management, and payments
- Manages all aspects of studies in accordance with established timelines, applicable regulations and standards, and Zimmer Biomet standard operating procedures
- Maintains detailed project plans, dashboards, timelines, and budget reviews for all projects; updates department director on an ongoing basis
- Facilitates corporate and IRB review and approval processes for all new clinical studies and investigative sites
7
Experience For Clinical Affairs Liaison Resume
- Manages External Research proposals- overseeing corporate approval processes, execution of agreements, completion of milestones and reports, and payments or in-kind contributions
- Contributes to drafting, updating, and reviewing standard operating procedures, work instructions, and controlled forms
- Contributes to review and approval of risk management plans, design reviews, and IFUs, where clinical input is needed
- Reviews and analyzes chart documentation: OASIS, adjunct evaluations, referral documentation, and Plan of Care
- Codes diagnoses accurately and sequences correctly according to ICD-9-CM Guidelines and Conventions (ICD-10 when launched) based on supporting documentation in electronic medical record (EMR)
- Meets OASIS and POC time lines according to Medicare requirements
- Enters appropriately selected and sequenced diagnosis codes into the EMR diagnosis profile area, if applicable
- Completes OASIS Recommendation Form with diagnosis codes and with OASIS recommendations, if applicable, and sends document to appropriate agency within 48 hours of receipt of case or receipt of clarifying documentation
8
Experience For Director of Clinical Affairs Resume
- Supports and trains others in the coding process, coding guidelines and conventions and OASIS guidelines and current interpretations as appropriate
- Participates in Performance Improvement Programs as needed
- Directs and controls assigned operations and information to maintain sound privacy and security practices and prevent privacy or security breaches. If a breach occurs, takes corrective action and notify Regional Director of OASIS and Coding
- Maintains confidentiality on all patients as prescribed by Almost Family, Inc., policy and procedure
- Manages medical monitoring processes, core-labs, and other contracted study vendors. Liaises with study committees such as Steering and Data and Safety Monitoring Committees
- With Regional Sales Managers, design, deliver and support local CE courses which provide dental professionals with high quality, procedural based continuous education
9
Experience For Senior VP of Clinical Affairs Resume
- With KAM/RSM, develops post event reports and analysis to determine effectiveness or each event and speaker performance
- Support the Clinical Lead in building a programme of events within the London Academy and maximising the use of the facility including use by 3rd parties
- Develop event agendas and manage participation of all speakers including development of course content, aim, objectives etc inline with CPD requirements
- Support the delivery of digital/online learning content
- Support the improvement of dental IQ of the UK&I Sales & Marketing teams
- An M.S. or Ph.D , preferably in areas of life science, engineering or equivalent
10
Experience For Executive Assistant, Clinical Affairs Resume
- Experience in clinical trials and regulatory submissions (PMA and 510k), supporting new product launches as well as product updates in the IVD or Molecular Diagnostics field
- Familiarity with international regulations for IVD Clinical Trials and prior experience in the acquisition and management of clinical trial samples
- Develop and maintain a thorough understanding of the clinical application and potential for HYH technologies and adjacencies
- Fluency with Microsoft Office and Microsoft Outlook
- Cultivate collaborative relationships with KOL’s (national/international)
List of Typical Skills For a Clinical Affairs Resume
1
Skills For Clinical Affairs Manager Resume
- Proven ability to manage multiple time-sensitive high priority projects
- Experience in interfacing with key opinion leaders including physicians and clinical laboratorians
- Gain experience with clinical research and clinical operations - Specifically working on clinical studies/trials in regulated environments
- Support investigators wishing to publish or present their experience with company products
- Experience with clinical trials involving hemostasis
- Gain experience though the development of material for key internal and external stakeholders
- Address the needs for clinical evidence and marketing claims for new and existing products In collaboration with Business and Development
- Introducing Philips Oral Health Care products to dental professionals to gain their trial and recommendation
- Attending local, regional, and national trade shows as defined by territory needs
2
Skills For Clinical Affairs Specialist Resume
- Managing Customer to Distributor and other systems on a daily basis
- Analyzing the customer structure in given area and maintain CRM database
- Managing sales expenses responsibly
- Developing metrics and performance evaluation processes for faculty members’ clinical contribution
- Understanding of molecular and virology laboratory techniques
3
Skills For Clinical Affairs Coordinator Resume
- Operational expertise covering all study stages from set-up to study report (whether leading these steps or having contributed to these activities)
- Take responsibility of ensuring the execution of clinical trials with the goal of adhering to target timelines, budget and quality
- Select and manage qualified investigational sites and investigator qualification and training
- Provides medical expertise and leadership to the Clinical, Regulatory, Quality, Research, Development, and Marketing groups
- Be flexible, open-minded, and adapt successfully to changing business conditions
- A history of operating with a sense of urgency and a drive for results
4
Skills For Head of Clinical Affairs Resume
- Independent planning of daily activities
- Work with the Legal Department and TMTT management to obtain approval for consulting agreements
- Provide administrative support to department to include: Office supply orders, catering requests and other vendor
- Supports clinical team member’s requests for filing or document retrieval of study documents
- Work with internal R&D, RA, QA, and Marketing teams to design and manage clinical trials to support the company’s roadmap and strategy
- Understand clinical strategy development through interaction with Clinical Affairs project managers
- Exposure to the abstract, poster presentation or manuscript development process for key surgical conferences and/or journals
- Agile and flexible team player with the ability to meet project timelines and complete clinical affairs deliverables to meet global regulatory requirements related to clinical trials
- Understanding of regulations and guidelines governing the areas of medical device and in-vitro diagnostic development, with a broad knowledge of requirements and best practices in Clinical Affairs, Regulatory Affairs and Product Development
5
Skills For Senior Specialist, Clinical Affairs Resume
- Proven ability to multitask, collaborate in cross-functional teams, and work independently
- Excellent communication skills and working knowledge of English grammar, punctuation and overall writing skills, with the ability write clinical trial reports and documentation independently
- Critical-thinker with excellent negotiation skills and the ability to address complex situations independently, and the ability to adopt a systemic view of continuous process improvement to support business goals and decisions
- Develop or revise clinical trial procedures and processes
- Manage implementation of clinical research strategies to meet business goals and objectives with the primary focus in the Endoscopy business, including GI & R and ET
6
Skills For Administrative Assistant, Clinical Affairs Resume
- Participate in data analysis, interpretation and synthesis, instructions for Use development, and Risk Management activities
- Maintain responsibility for successful execution of Endoscopy clinical studies in compliance with investigational plans and all applicable regulations
- Provide input and/or determine patient recruitment strategies, operational feasibility and implementation of study/program objectives
- Develop, implement and maintain standards across clinical studies within a program including, but not limited to new hire training for CTMs/CRCs, tools, templates and CRO manuals Hires, supervising and training personnel (CRA and/or CTC) and taking ownership of the quality of assigned clinical programs and deliverables
- Set annual goals, objectives and development plans for staff, provide performance feedback and conduct performance evaluations
- Prepare clinical protocols, data collection tools and ancillary documents
- Support regulatory submissions and participate in the development of project management plans and data management plans, statistical analysis plans
7
Skills For Clinical Affairs Liaison Resume
- Author clinical study reports and Co-author abstracts, white papers, and/or manuscripts for the clinical studies
- Participate in preparation of annual and ad-hoc reports and ensure integrity of data submissions to IRBs and/or regulatory authorities
- Assist in preparation of manuscripts, abstracts, slide presentations, and poster presentations for scientific meetings and publications
- Review and integrate statistical output from clinical trials and registries, and determine the appropriate evaluation, interpretation, and presentation of data
- Conduct literature searches, with guidance from Medical Director, on products and product families to assist research and development efforts, to provide input on risk management processes, to support the creation of Clinical Evaluation Reports, and to develop clinical strategies and clinical investigational protocols
- Experienced in scientific literature searches, retrieval and evaluation
- Experienced in the use of electronic data collection & managements systems
- Experienced leader of clinical research / operations teams in the medical device, pharmaceutical or biotech industry
- Review study proposals submitted by prospective investigators
8
Skills For Director of Clinical Affairs Resume
- Responsible for making timely decisions that reflect a consideration of the facts and data at hand and are in alignment with the overall business organization’s goals
- Standard office environment with possible local travel to Partners sites and sites within the Boston area
- Proven track record in design and development of human clinical research projects including: protocols, clinical investigational plans, regulatory strategies and clinical study report compilation for regulatory submissions
- Practical knowledge of FDA guidelines and local regulations concerning clinical research, ICH guidelines, Good Clinical Practices (GCP), and other related Standards governing the conduct of medical device clinical trials
- Establish and maintain effective working relationships with faculty, staff, students, residents and professional personnel at all levels
- Set priorities and to plan, organize, and coordinate multiple projects and activities simultaneously while working under tight deadlines
9
Skills For Senior VP of Clinical Affairs Resume
- Knowledge or experience in a healthcare field, an academic setting or business environment. Ability to effectively communicate with leadership, management, faculty, staff, residents and students
- Be creative, supportive and thoughtful in problem-solving, considering the diverse and occasionally conflicting needs and perspectives of the faculty, staff and institution
- Develop and execute a US clinical affairs tactical plan in autoimmunity, aligned with the global strategic roadmap and tactical plans
- Develop, influence, and utilize key opinion leader network to drive advocacy for our products, including initiating collaborations with clinicians and laboratories utilizing our products
- Initiate/execute symposiums, as well as encourage abstracts, at major national congresses and establish/monitor KPIs to ensure efficacy in influencing targeted customer base
- Provide clinical affairs coverage of key medical/scientific congresses and cooperative group meetings as needed. Listen for and interpret new clinical data and competitive intelligence, and report back on findings to clinical affairs and marketing stakeholders
- Identify and engage national groups working with guidelines, as well as support development & implementation of evidence-based clinical guidelines
10
Skills For Executive Assistant, Clinical Affairs Resume
- Partner with field sales and sales management to provide peer-to-peer programming for targeted clinicians & KOLs, through programs and presentations that communicate the advantages of Thermo Fisher Scientific’s autoimmune diagnostic testing
- Interface with Medical Affairs team and Marketing team to provide clinical expertise in message development, with the goal of incorporating IDD’s immunodiagnostic products and services into laboratories across the US and the routine practice of health-care providers
- Experience working with external international partners
- Five years+ of clinical nutrition experience in ketogenic and IEM setting
- Data entry and administrative experience
- Clinical trial development and management experience
- Experience in a clinical role in an FDA regulated industry required
- Experience with invoicing, accounts payable and resource management
- Experience with auditing personnel practices
List of Typical Responsibilities For a Clinical Affairs Resume
1
Responsibilities For Clinical Affairs Manager Resume
- Demonstrated ability to act as CAM lead, leading the study team and being able to efficiently work with other CAM’s in the same study
- Experience in one of the following is required
- Demonstrated ability to design studies, and write and review the resulting study reports and publications
- Understanding of data base concepts
- Understanding of Clinical Study Support and Facilitation
- Provide input to projects regarding requirements and strategies for clinical studies
- Participate in the training of new CAMs on therapeutic area and general responsibilities within their function
2
Responsibilities For Clinical Affairs Specialist Resume
- Provide action plans for decision making
- Adapt and be flexible to change, managing internal and external challenges & opportunities
- Knowledge and qualification with international standards (e.g. GCP, CDISC, etc.), company tools (including data management systems, processes and SOPs)
- KOL Identification and Planning
- National Coding ICD-10 certification required
- Partner with R&D & New Ventures to drive identification, analysis, and development of new therapies and treatments
- Develop & leverage relationships with key societies to support broad business goals
- Assist with strategy/speakers/content for programs, symposia, and peer-to-peer education
- Related experience in a commercial life sciences organization (drug and/or device) with emphasis on understanding of basic anatomy and the clinical environment
3
Responsibilities For Clinical Affairs Coordinator Resume
- Excellent writing and presentation skills, with specific emphasis on writing for scientific publication (including process and requirements) – publication sample required
- Effective oral and written communication with medical professionals, scientists, peers, and senior management, with emphasis on Key Opinion Leader development, both domestic and international
- Actively represent clinical affairs in the UK & Ireland; internally and externally for reimbursement or other government agency meetings or conferences as required
- Assist in data mining strategic program outputs
- Data entry for all OPERA accounts
- Assist in design and development of data interface
- Identify additional survey requirements to optimize data collection
- Demonstrated ability to successfully manage and execute clinical studies with medical devices to meet business goals using standard best practices and compliance norms. The
- Demonstrated ability to supervise CRAs and Monitors, and work successfully on cross-functional teams
4
Responsibilities For Head of Clinical Affairs Resume
- Conscientious in matters of personal work organization, assistance to managers in organizational processes, detailed record-keeping, and follow up
- Demonstrable skills and experience developing Clinical Investigational Plans, launching all aspects of a clinical study and managing multifunctional teams in an efficient, effective and compliant manner
- A strong work ethic, self-motivation, and entrepreneurial drive are required, as are high personal values and standards. Honesty, integrity, the ability to work with minimal supervision, a conscientious approach to meeting goals and objectives, and the ability to handle pressure with grace and humor are equally important
- Work independently, using sound judgment, initiative and analytical abilities, to accomplish short and long-range projects, anticipate likely needs, and recommend actions with minimal direction
- Excellent interpersonal and negotiating skills; ability to solve problems creatively; ability to adapt to changing work priorities; and ability to maintain good working relationships while dealing appropriately with sensitive and confidential matters and with a wide variety of personal and telephone contacts
- Coordinate the pathology clinical affairs needs and activities with pathology business management. Liaison with site management on clinical and medical affairs support
- Plan, conduct, and report clinical studies along with Clinical Trial Manager and Clinical team
- Authors Clinical Investigations section in Premarket Approval Applications, specific sections in Instructions for Use (IFU) and authors Performance Testing Clinical section in 510(k) submissions. Prepares, revises and maintains procedures for the conduct of studies
- Interact with either internal or external statistical experts to secure optimal study design and analysis of study results
5
Responsibilities For Senior Specialist, Clinical Affairs Resume
- Develops and designs database and Data Report Forms, in paper as well as in electronic data capture systems
- Ensures data management deliverables
- Contributes to clinical portion of FDA documents as requested by Regulatory Affairs
- Supervise and guide Clinical Affairs Specialists and Clinical Trial Managers on protocol and report preparation, data management and related activities within Medical and Clinical Affairs as needed
- Drive the preparation, revision and implementation of Medical and Clinical Affairs SOPs
- Remain updated and trained on relevant requirements for the conduct of clinical studies globally with main focus on US, Europe, Japan and emerging markets like China
- Qualify cost and time estimates on Clinical Affairs Specialist core deliverables and give input to project resource requirements and allocations
- To thrive in the job we are looking for an individual, that have an attention for detail and enjoy writing technical documents, as well as appreciate discussing technical details with subject matter experts
6
Responsibilities For Administrative Assistant, Clinical Affairs Resume
- Ensures accurate, complete, timely and effective communication of study status and related issues are reported cross-functionally and to appropriate personnel at participating PKI sites
- Organize and lead study specific meetings
- Collect, synthesize and report study information
- Participate in selection and management of vendors, development/follow-up of the associated budget
- Anticipate, timely escalate issues and to define appropriate action plans
7
Responsibilities For Clinical Affairs Liaison Resume
- Capability to routinely perform data management activities and oversight, data review and analysis (clinical & operational) to propose actions and a remediation plan
- Experience in the management of vendors for outsourced activities
- Experience with managing group
- Experience in a fast-paced, highly regulated healthcare environment
- Experience with administrative support services and use of Microsoft Office suite
8
Responsibilities For Director of Clinical Affairs Resume
- Appropriately delegate responsibilities (e.g., Internally - when several CTMs involved on a study/ Externally - in case of outsourced activities)
- Adapt his/ her communication, address the right topics and adapt content/level of details to the right recipients, select topics to be addressed internally first
- Encourage collaboration and communication within and beyond the team
- Make decisions when needed and take responsibility (accept accountability for results, even if the outcomes are difficult or sensitive)
- Effectively interact with scientists and managers within and outside CSO SCP, serving as internal consultant on assigned area (e.g. Subject Matter Expert) and liaise with external organizations on projects
- Experience in immuno-hematology is an asset
- Work in an international environment with internal and/or external partners (e.g vendors, database designers, programmers)
- 3) Communication responsibilities
- Board certification (American Board of Internal Medicine or equivalent)
9
Responsibilities For Senior VP of Clinical Affairs Resume
- International recognition for leadership in above
- National OASIS-C2 certification required
- English language required other European languages an advantage
- Structured, well organized and flexible
- Dedicated team player who inspires trust amongst colleagues
- Registered Dietitian credential desirable
- Active sales to dental professionals
- Educational programs for DH schools
- Trainings for distributors, retailers
10
Responsibilities For Executive Assistant, Clinical Affairs Resume
- Achievement of all sales quotas
- Understands the significant role of Clinical Affairs to facilitate adoption and use of a company’s medical device products and solutions to increase clinicians competency, effectiveness and efficiency
- We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year
- Initiate, design and coordinate in vitro diagnostic studies to collect data to support submissions to regulatory authorities and future product development
- Report to Director, Pre-Market Clinical & Regulatory Affairs, Quality Technology, Point of Care Business Area
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• Establishes or ensures the establishment of work priorities and provides daily supervision and support to all assigned staff
...
Professional Skills
• Strong organizational skills, attention to...
• Excellent verbal, written and communicatio...
• Excellent verbal, written & communication ...