Clinical Data Management Resume Sample
Santina Turner
84008 Clair Club,
Detroit,
MI
+1 (555) 346 0137
Work Experience
Associate Director, Clinical Data Management
06/2015
-
PRESENT
Detroit, MI
- Ensures that all aspects of the Company’s data management processes, procedures, and technology are consistent with current industry practices and meet all pertinent regulatory requirements, both domestic and international
- Develop a team of high-performing staff
- Serves as Clinical Data Management Project Manager by providing leadership and management of data management activities. Directs data management activities according to quality standards, regulatory requirements and ensures adherence to project budget from study start up through archival in support of key development programs
- Directs and ensures all applicable data management databases are developed, validated, and meeting AnaptysBio’s business requirements
- Works in collaboration with Quality Assurance and other functional groups to develop and update data management standard processes and procedures in accordance with CFR, GCP, ICH Guidelines and GCDMP, FDA regulations, CDISC and FDA submission standards and best practices. Maintains currency, including regulatory expectations
- Contributes to definition and setting of both strategy based on Senior Management’s input and operations for clinical systems and data standards. Provides business process and technical direction to facilitate adoption and use of technologies for Data Management and trial management
- Evaluates Data Management outsourced activities to ensure efficiency and regulatory compliance. Provides study teams with recommendations on selecting Data Management vendors during selection process
- Formulate short-term and long-term strategies to improve DM efficiencies
Clinical Data Management
12/2011
-
01/2015
Chicago, IL
- Assignment of staff, providing support and guidance as needed, and working with peers to ensure consistent approaches in-
- Gathering of data collection requirements from various stakeholders for systems/applications deployed to collect clinical trial data (eCRFs, ePRO, eCOA, etc.), including ensuring adherence to defined standards
- User acceptance testing to ensure high quality deliverables and inspection readiness at all times
- Implementation of the Data Quality Management Plan (DQMP) defining and documenting the data quality review strategy for each clinical trial in collaboration with various BMS stakeholders (e.g. statistics, medical, safety, development, GCO, etc.), enabling the quality review of patient data supporting regulatory filings, publications and other high-profile business activities
- Supporting clinical study report creation with input to the data quality assurance section as well as provisioning of sample and completed eCRFs/ePROs/eCOAs
- Ensuring effective quality oversight and management of external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing data management services on behalf of BMS
- Contributing to the development and application of smart systems and optimal approaches to support the collection, integration, monitoring, review, and reporting of data to simplify and enhance user experience or lead to efficiencies in execution
- Focusing on continuous improvement, defining and implementing the changes required to create an industry-leading clinical data capability, including electronic data capture, external data integration, ad-hoc analysis and end-to-end data standards
Clinical Data Management Intern
04/2006
-
10/2011
San Francisco, CA
- Cultivate effective and productive working relationships with colleagues, subordinates, vendors, and management as well as solve problems and escalate issues with proposed solutions to Senior Management as needed
- Accountable for hands-on management of trials and resources while maintaining a high level of data quality by adhering to corporate, industry and regulatory agency standard
- Review and provide feedback on draft protocols, Statistical Analysis Plans, CSRs and other documents as required
- Reviews and or develops standard operating procedures (SOP) and work instructions (WI) for data management department and participate in cross functional SOP and WI document review
- Excellent organizational skills and demonstrated ability to delegate and monitor quality of outputs
- Providing leadership of clinical data management activities across multiple clinical development programs, overseeing a team of clinical data management professionals in planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision making, regulatory approval and market acceptance
- Effective coaching and mentoring of Data Management Leads (DMLs) and other clinical data management staff in the team to ensure consistently high levels of performance and productivity in support of various clinical trial teams
- Strong coordination of activities across clinical data management, clinical data acquisition and standards, clinical data reporting and analytics, centralized monitoring, and medical coding to ensure cohesive support to clinical trial data collection, review, and reporting
Education
University of Wisconsin–Marinette
2002 - 2006
Bachelor's Degree in Biological Science
Professional Skills
- Proven strong organizational and problem-solving skills
- Proven organizational skills with ability to be flexible, work with ambiguity and serve up options to resolve ambiguity
- Demonstrated team leadership and project management skills
- Proven effective communication skills both orally and written with both technical and business areas
- + Strong leadership and interpersonal skills
- Apply technical knowledge to work activities and use critical thinking skills for problem identification and solving
- + Demonstrated skill for mentoring and developing staff on technical and core competencies
How to write Clinical Data Management Resume
Clinical Data Management role is responsible for technical, leadership, database, training, integration, procurement, auditing, oncology, design, research.
To write great resume for clinical data management job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Clinical Data Management Resume
The section contact information is important in your clinical data management 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 Data Management Resume
The section work experience is an essential part of your clinical data management 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 data management 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 data management position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Clinical Data Management resume experience can include:
- Ensuring adaptive management of a global team through the effective deployment of resources and streamlined processes, ensuring productivity targets, validity and quality of the data gathered in support of the evolving portfolio of BMS products
- Experience to work effectively in a smaller company environment
- Good written and verbal communication skills in Chinese and English
- Prioritize and effectively manage several large projects simultaneously
- + Excellent oral and written communicat ion and presentation skills
- Strong team building and resource allocation experience
Education on a Clinical Data Management Resume
Make sure to make education a priority on your clinical data management resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your clinical data management 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 Data Management Resume
When listing skills on your clinical data management 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 data management skills:
- Solid analytical and proactive problems solving skills
- Exhibits composure and strong conflict management skills
- Manage in a matrix organization by effectively maintaining and building relationships across Business groups
- Successful experience managing vendor relationships and alliance partnerships with at least 4 years experience in this area
- Strong knowledge of relational databases and experience using multiple clinical data management systems
- Proven experience in data profiling and associated remediation approaches to deliver complete and quality solutions
List of Typical Experience For a Clinical Data Management Resume
1
Experience For Associate Director, Clinical Data Management Resume
- Representing the Company in interactions with key external partners as part of any committee or industry group relating to data management
- Performance Management – responsible for hiring, training and ongoing appraisal and development of team members
- Developing strong and productive working relationships with key stakeholders throughout BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management
- Engaging and energizing employees through communication of goals, priorities and other business critical information as well as focus on employee value proposition, development and retention activities
- Developing and promoting a work place culture that values diversity of thought, promotes integrity and creates an atmosphere that supports coaching and fosters accountability
- Strong knowledge of FDA/ICH guidelines and industry standard practices regarding data management
- Create, review, and approve study documentation following GxP and sponsor’s policies, guidelines, and procedures
- Ensure project management and resources planning aligned with business needs
- Attend client meetings and lead discussions of project requirements and strategic planning
2
Experience For Director, Clinical Data Management Resume
- Select vendors and technology to meet the needs of Kite’s clinical development programs
- Maintains current professional knowledge in fields of information management, computer science, quality assurance, regulatory affairs, and applicable areas of medical sciences to serve as a basis for providing “value added” expanded company services to all appropriate client
- Trains appropriate team members on department SOP’s and identifies gaps in current processes and develops solutions
- Responsible for overseeing all data management activities leading up to and including interim and/or final database locks inclusive of interacting with the appropriate cross-functional staff: Clinical Operations, Biostatistics and programming to meet Company’s objectives
- Leads strategic planning and execution of the department’s objectives including timeline and budget projections, risk mitigation strategies, and data management governance
- Direct people management responsibilities including performance evaluations, goal setting, career development, and departmental growth
- Provides leadership, training, and support to Data Managers
- Define, implement, and maintain eCRF standards (CDASH) and data capture conventions and CDISC compliant output for statistical analysis
- Oversight of key documents such as data validation specifications and programs, manual data review guidelines, computerized edit check programs, Data Management Plans (DMP), etc
3
Experience For Senior Mgr / AD, Clinical Data Management Resume
- Lead computer system development initiatives including database integration, data sharing, access and storage. Lead and/or support other technology-based initiatives such as ePRO, eSource, PV database, CTMS implementation
- Coaches, develops and provides continuous feedback to a team of direct reports; provide guidance and direction to ensure departmental and client/project goals are met
- Oversee the Data Management operation
- Serve as point of contact for Data Management function with company senior management to carry out company vision
- Strategy development for the operation and financial health of Data Management function
- Ensure Data Management process in place and execution for quality services
4
Experience For Head, Clinical Data Management Resume
- Interact with clients to ensure open communication and issue escalation channel
- O Assist with the generation and maintenance of data management-related documentation including case report forms, data management plans and edit specifications
- Defines data handling conventions, quality acceptance and auditing criteria for data collection and data deliverables
- Acts as the data expert and represents CDMT on study team as applicable
- Works with CRO to ensure data collection tools capture protocol requirements
5
Experience For Senior Manager / AD Clinical Data Management Resume
- Identifies and resolves data flow process issues in collaboration with the project team
- Provides guidance and sponsor approval per CRO SOPs and process exceptions
- Serves as an internal CDMT expert for cross functional team members
- Liaises with third-party vendors in support of study team escalations
- Monitors timelines to ensure data management-related deadlines or contributions to study deliverables are proactively defined and met
6
Experience For Senior Mgr Clinical Data Management Resume
- Algorithms and standard proposal text
- Manage CDAs efficiently across studies by setting goals and providing oversight, guidance, mentoring, feedback and performance reviews. Lead hiring and training activities as needed
- Manage/coordinate work performed by vendors/CROs as appropriate to ensure quality of product. Assist in the selection of vendors/CROs (e.g. review RFPs, attend site audits)
- Guide team members through the development of DM documents including but not limited to DMPs, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans
- Guide team members through data cleaning activites such as but not limited to Study Team data reviews, SAE reconciliation, non-CRF data reconciliation, and data cleaning timeline/strategy development
- Experience having served as a subject matter expert on regulatory audits
- Proficient on implementing new data standards, technologies, and systems. Capable of leading implementation teams
- Proficient on developing request for proposals for external vendor contracts, and on evaluating external vendor contract for project procurement
- Perform study resourcing and budget support as appropriate
7
Experience For Clinical Data Management Intern Resume
- Direct and guide team through DM Lifecycle associated with P1-P3 studies, including pivotal, blinded, and randomized trials
- Knowledge and understanding of non–CRF data flow, transfer, and integration
- CDASH – Implement and perform versioning; develop global standard CDASH case report form library and code lists; implement in EDC
- Guide team members through the database lock process in an efficient and timely manner
- DM Project Management: Understands critical tasks and milestones; ensures data management deliverables are met per study timelines
- Drive and guide complex process and initiatives
- Communicate and message information to multiple levels of leadership appropriately; applying appropriate level of detail to audience to ensure efficient utilization of resource
- Research, evaluate, and direct departmental initiatives and new technologies/innovations to improve CDM processes; represent CDM through working groups (internal and external) and initiatives where thorough knowledge of CDM practices/processes are required
8
Experience For Clinical Data Management Associate Resume
- Encourage collaboration through relationship building with other leaders; ability to influence without authority
- Support of implementation of data standards
- Align with and support management and corporate objectives
- Manage GCDM personnel, priorities, and workload on the preparation, validation, processing, reviewing, querying, dictionary coding, and maintenance of clinical data on individual clinical trials and regulatory submissions
- Approve request for proposals (RFPs) for external GCDM vendor contracts. Develops and evaluates external GCDM vendor contracts and budget for project procurement
- Manage CROs, external vendors, and clinical trial project teams
- Implement new approved technologies and/or systems
9
Experience For Senior Specialist, Clinical Data Management Resume
- Serve as subject matter expert to focus expertise and problem solving strategies on one or more of the following areas below for use across all clinical trials. Lead implementation team(s) appropriately and develop, implement, and version data standards
- MedDRA and WHO-DD Coding – Implement centralized dictionary coding and dictionary versioning
- Electronic Data Capture, Medidata/RAVE – Implement screen/system development; expertise on underlying data structure and data storage; manage technical system problems and take corrective action; support ad-hoc report development
- Laboratory data standardization and collection – Define global laboratory standards library and reports; perform laboratory data review, standardization, identify data discrepancies and corresponding resolutions
- Experience in clinical data management of 7-9 years. Experience in managing reports of 5-7 years
- Experience in developing SOPs
- Lead the clinical project team to develop CRF/eCRF according to CDASH for clinical trials
10
Experience For Specialist, Clinical Data Management Resume
- Provide training and development to GCDM personnel; prepare and conduct performance reviews. Recruits for new staff
- Develop and finalize global clinical data management SOPs. Develop, modify, and execute crossfunctional company policies
- The position reports to the highest level of GCDM or Biometry management
- Possess a thorough knowledge of medical terminology; and the clinical data management and the clinical trial process
- Proficient on regulatory requirements for data management and the regulatory submission process
- Proficient on the design and validation of data collection instruments; the data collection and data review process; data standardization; laboratory data theory, design, and collection
List of Typical Skills For a Clinical Data Management Resume
1
Skills For Associate Director, Clinical Data Management Resume
- Demonstrated skills in continuous improvement, project management, change management, and risk management
- Possess effective written and verbal communication skills necessary to interact with personnel at all levels within and external to the company
- A good understanding of the drug development process with proven expertise in clinical trial execution and management in a global arena
- Strong Coaching, management and execution skill
- + Demonstrated skill for technical and supervisory leadership of 8-15 staff within one or more locations in a region
- Experience in successfully managing large-scale technology projects -- including integrated multiple business areas or systems
- Experience with developing and implementing GDMS strategy for in-licensed and/or out-licensed programs
- Implement, control, and understand productivity measures and a good understanding of financial control
2
Skills For Director, Clinical Data Management Resume
- Solid understanding of data management best practices and associated business and IT processes
- Diligent and serious, precise thinking, strong sense of responsibility to assigned daily works
- EDC and coding experience with WHO Drug and MedDRA desirable
- Experience working with project management tools and processes
- + Operational experience in other disciplines such as clinical, biometrics, medical writing, pharmacovigilance, safety, quality assurance, regulatory, etc
- Data management experience in the pharmaceutical industry
- Line management experience
- Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials
- Experience with common DM systems. e.g. Medidata Rave, ClinTrial, InForm. Know hands-on daily data management practice
3
Skills For Senior Mgr / AD, Clinical Data Management Resume
- Experience with common DM systems e.g. Medidata Rave, ClinTrial, InForm
- Capable of prioritizing individual and CRO/Vendor tasks based on timelines and study needs
- Extensive experience with all study phases and with large, complex clinical programs
- A demonstrated proficiency in efficient database and/or SAS dataset design
- Ideally 10 or more years’ experience in drug development with at least 8 years in Clinical Data Management
- Strong knowledge of SOPs, GCP standards and CDM systems
- Demonstrated partnership across various collaborative forums, CROs, SMOs and/or local site networks
- Influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a geographically diverse team
4
Skills For Head, Clinical Data Management Resume
- Provide strong management of people, process and data
- Experience in Clinical Data Management
- Able to work independently and as a member of team with equal effectiveness
- Experience managing clinical data management deliverables for regulatory filings
- Experience in CDM within clinical development
5
Skills For Senior Manager / AD Clinical Data Management Resume
- Proven track record in providing successful leadership in data management
- Demonstrated ability to identify and execute staff development strategies
- Possess management experience; training and development of personnel; and preparation and conducting performance reviews
- Validate GCDM department to ensure audit readiness. Serve as GCDM subject matter expert on regulatory audits
- Strong knowledge of submission requirements [e.g. New Drug Application (NDA)/Market Authorization Application (MAA)]
6
Skills For Senior Mgr Clinical Data Management Resume
- Zero (0) to two (2) years of direct experience in Pharmaceutical industry or related field
- Assigning work, reviewing work, and Planning other’s work
- Understanding of relevant regulatory guidelines, GCP and international guidelines regarding data management
- Providing operational input into proposals for large programs and strategic partnerships, including input to costing
- Defining and implementing department objectives
- Monitoring quality and efficiency across projects
- Work with study team members by preparing and distributing study related reports, resolving questions and providing DM guidance
- Provide leadership and contribute to strategy decisions regarding data management solutions for Akebia
- Led business and IT team to deliver data warehousing and analytics solutions
7
Skills For Clinical Data Management Intern Resume
- Develop and manage data analytical and profiling approach and processes
- Define and implement clinical data mapping and management tools and methods to be used for all UHC initiatives
- Create data testing plans in support of test execution
- + In depth knowledge of tracking of staff productivity and quality metrics
- + Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical biotechnological companies
- Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process
- Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function
- Provide oversight and participate in study setup and initiation procedures such as CRF design, database design, edit check design/review, DMP (Data Management Plan) review/approval and annotated CRF design
8
Skills For Clinical Data Management Associate Resume
- Ensure accuracy, completeness, and consistency of clinical trial data by performing or managing CDM staff in the oversight of data collection and data cleaning final quality review activities, the review of analysis tables, listings, and figures and archiving study databases and supporting documents
- Apply experience and education to initiate and develop new and more efficient processes and procedures for study setup, maintenance, closure and archiving activities to meet business needs
- Develop and implement changes to DM guidelines and quality processes to ensure clinical databases, external data files and analysis datasets are designed in a standard, accurate, complete and consistent format conducive to analysis and regulatory submissions
- Ensure that optimal relationships are developed with internal customers/colleagues and with new or existing strategic partners/vendors
- Knowledge in using any clinical database management system
- Coordinate the acquisition and development of tools to support data management tasks internally and externally with DM and software vendors
9
Skills For Senior Specialist, Clinical Data Management Resume
- General office equipment: computer, printers, copier, fax machines
- Responsible for ensuring timeliness and high quality for all Data Management (DM) deliverables globally within a therapeutic area. Provides oversight of DM budget in collaboration with program management
- Contributes to management of strategic vendor partnerships in order to maximize effectiveness and efficiency of external (CRO) resources
- Responsible for vendor oversight activities across all global development programs within a therapeutic area. Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and Takeda for all data related deliverables, especially in support of key decision points and regulatory submissions
- Provides input to functional governance with Takeda’s strategic suppliers. Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams
- Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Pharmacovigilance and Statistics
- Responsible for vendor oversight activities across all global development programs within a
10
Skills For Specialist, Clinical Data Management Resume
- Therapeutic area. Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and Takeda for all data related deliverables, especially in support of key decision points and regulatory submissions
- Demonstrated ability to plan, design, and implement data and information collection
- Demonstrated ability to analyze data/information for accuracy, validity, and integrity; the ability to maintain quality control and assurance; the ability to apply criteria or parameters for extract of data/information; the ability to interpret and evaluate results; and the ability to prepare reports and/or presentations
- Demonstrated ability to provide consultation and instruction
- Data Management experience in the Biotech/Pharma/CRO industry
- Line management and project team leadership experience
- Extensive experience in the design and implementation of technical data management systems targeted at supporting large-scale multiple site clinical trials including supervisory experience
List of Typical Responsibilities For a Clinical Data Management Resume
1
Responsibilities For Associate Director, Clinical Data Management Resume
- Exceptional communication skills (oral and written), with the ability to communicate with both the technical and business areas
- Exceptional people and thought leadership skills, with the ability to think strategically and to influence others
- Strong knowledge of the Drug Discovery Process, ICH and GCP guidelines
- Proficient with: (a) CDASH, (b) MedDRA and WHO-DD dictionary coding and versioning, (c) SAS for data review
- Proficient with electronic data capture (EDC) system Medidata/RAVE
- Proficient with the development of CRF/eCRF for clinical trials and its impact into database design/development
- Experience in solving extremely complex and increasingly difficult problems, independently taking the appropriate corrective action, and identify and implement improvements. Able to review, interpret and evaluate clinical data
2
Responsibilities For Director, Clinical Data Management Resume
- Demonstrate initiative, sound judgment and flexibility; possess effective time management and organizational skills; and be able to work under deadlines and on multiple projects simultaneously
- Able to effectively coordinate personnel, vendors, teams, and projects
- Exhibits strong experience with multiple facets of drug development process, effectively transforming ideas into high quality process improvements and clinical strategies
- Key strategic member of the Biometrics and Data Operations Leadership Team
- Expert knowledge of Drug Development process
- Provide quality Data Management related assistance to clinical studies
- Assist Data Management team in the generation of Annotated CRFs
- Assist in the development of Data Management manuals for clinical studies
3
Responsibilities For Senior Mgr / AD, Clinical Data Management Resume
- Support multiple (5-10) clinical studies
- Professional customer focused approach
- Take a supporting role in the review and query of clinical data, including participation of the critical review of data-populated tables, figures, and listings as part of the database clean-up and prior to database lock
- Demonstrated knowledge of all aspects of data collection and query resolution in clinical studies
- Guide team members through data cleaning activities such as but not limited to Study Team data reviews, SAE reconciliation, non-CRF data reconciliation, and data cleaning timeline/strategy development
4
Responsibilities For Head, Clinical Data Management Resume
- Serve as the expert in Clinical Data Management (CDM) to provide oversight and advice to the clinical project team regarding the CDM activities and deliverables. Manage and resolves escalated issues related to CDM deliverables. Represent CDM during any vendor interaction
- DM experience and 2+years of supervisory experience
- Relevant CDM experience
- Technology and large program management experience within a matrix organization
- Healthcare IT and data experience (>15years)
- Experience in data controls and associated IT operations best practices for data solutions
- Thorough knowledge of SDTM/ADAM data models and CDISC standard, programming techniques (SAS), analytical ability, and sound professional judgment is required
5
Responsibilities For Senior Manager / AD Clinical Data Management Resume
- Oversee Clinical Data Management (CDM) activities, specifically
- Experience in working in a matrix structured environment with multiple product lines. In-depth knowledge of FDA regulations and strong understanding and usage of medical terminology
- Handle multiple tasks to meet deadlines in a high stress environment
- Results and performance driven, sense of urgency and commitment. Team spirit, attention to details
- Know hands-on daily data management practice
- Diligent and serious, precise thinking, strong sense of responsibility to assigned daily works. Results and performance driven, sense of urgency and commitment. Team spirit, attention to details
- Knowledge in Clinical Database Development/Transformations, including tools in support of this exercise (e.g., InForm, Data Loading, SQL, Java) and System Development Lifecycle Management/system validation required
6
Responsibilities For Senior Mgr Clinical Data Management Resume
- BA/BS, preferably in a scientific discipline
- Communicate data management standards, developments, and challenges in an accurate, concise, consistent, organized and grammatically/situationally correct manner to both internal and external audiences
- Comprehensive understanding of DM responsibilities and project activities (i.e. budget, timelines, resources) and of linkages with tasks and responsibilities of other functions
- Use metrics to determine project status, monitor internal/external DM team progress and plan for project resources and monitor project budget
- Propose areas for development or process improvement and assist with staff compliance
- Familiarity with ICH GCP as well as full knowledge of industry practices and standards (CDISC, SDTM, CDASH)
- Capacity to work with little or no supervision with accuracy and thoroughness
- Create and publish appropriate metrics
- Manage the clinical data analysts
7
Responsibilities For Clinical Data Management Intern Resume
- Deliver complete analytics and drive adherence to best practices in the Population Health Platform, CentriHealth data analysis and data implementation
- Facilitate cross team discussions to ensure completeness of data findings and recommendations for sources
- Develop the Clinical Data Management Roadmap and Timelines for the PHP program
- + In depth knowledge of clinical trial process and data management, clinical operations,
- Self-motivated, independent, and results-oriented
8
Responsibilities For Clinical Data Management Associate Resume
- Knowledge of GCP, regulatory and ICH guidelines as applicable to clinical data management
- Focus on multiple projects of different duration and complexity
- Global clinical trial expertise and a successful track record of leading through influence, working across complex, global organizational matrices. Immuno-Oncology therapeutic experience is highly desirable
- Strong knowledge of industry leading eCRF tools (e.g. Medidata Rave, Oracle, etc.) and well versed in industry trends and emerging technologies supporting data collection
- Experience in data management and well versed in industry trends and emerging industry dynamics concerning data review
- A good understanding of database and dictionary structures (e.g. MedDRA, WHODrug)
- Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles
9
Responsibilities For Senior Specialist, Clinical Data Management Resume
- Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.)
- Broad intelligence of the clinical trial environment across key regions, and anticipation of future trends and impact
- Knowledge of the clinical development process with in-depth knowledge of the Clinical Data Management lifecycle through submission deliverables
- + Demonstrated ability to lead by example teams on strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions
- Experience in Clinical Data Management with at least 2 years’ of IRT Systems and/or COA working experience
- A broad comprehensive knowledge of the clinical trial process including data management (data collection, processing, storage, and retrieval), worldwide regulatory data submission, and reporting requirements
- Successful Project Leadership or Management of a significant cross functional initiative
10
Responsibilities For Specialist, Clinical Data Management Resume
- Gathers, evaluates and enters clinical data for the Bone Marrow Transplantation program to ensure receipt, completeness, and accuracy of research and departmental data requirements
- Responsible for monitoring of data and reports submitted to CIBMTR and other regulatory agencies to ensure that reporting requirements of those entities are met in a timely matter
- Ensures compliance with all regulatory aspects, as required, and maintains databases related to these regulatory aspects
- Develops, prepares and presents reports, charts, graphs and descriptive statistical analysis as required for Program periodic Quality Assurance meetings, Mortality and Morbidity meetings
- Reviews and provides data, analysis and reports for case reviews upon request in regards with specific outcome measures
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