Clinical Data Associate Resume Sample
Eliane Fay
98223 Marilie Walks,
Houston,
TX
+1 (555) 349 4725
Work Experience
Clinical Data Associate
07/2016
-
PRESENT
Philadelphia, PA
- Experience in clinical data
- Experience in device or pharmaceutical clinical trials is required
- Strong computer skills including EDC is required
- Familiarity with clinical trial design and analysis issues
- Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s) and communicates status updates to the Project Manager and/or Biometrics Project Manager as necessary
- Updates the Data Management Plan under the guidance of the PDM
- Creates and updates the SAE Reconciliation Plan
- Designs and/or reviews CRF/eCRF including eCRF visit structure co-coordinating with team members responsible for the associated database design
Senior Clinical Data Associate
11/2012
-
03/2016
Chicago, IL
- Creates and updates the CRF/eCRF Completion Guidelines
- Reviews database design specifications (including configuration, data structures, annotated CRFs)
- Provides input into the Data Validation Specification (DVS) including creation of edit checks for assigned forms including any post-production updates to the DVS and listings
- Creates and enters test data for data entry screens for UAT
- Performs UAT of Targeted Source Data Verification (SDV) configuration and matrices
- Creates and enter test data for edit checks
- Enters lab normal ranges
Clinical Data Associate / Coordinator
04/2008
-
05/2012
Phoenix, AZ
- Completes and submits CDMS-specific access forms and/or spreadsheets
- For paper studies, takes receipt of, and reviews, Data Clarification Forms (DCFs) that have been answered by sites and where appropriate, edits the CRF database accordingly. Submits copies of the DCFs to sponsors as necessary
- For paper studies, performs internal quality control checks via listing output from database against Case Report Forms (CRFs) and Data Clarification Forms (DCFs). Serves as QC Coordinator for paper studies
- For Rave studies, performs DM quality review and/or other internal quality control checks as required per applicable EDC systems
- Ensures that data from external databases/datasets such as central and/or local laboratory data, electronic diary data, pharmacokinetic (PK) data, or Interactive Response Technology (IRT) are consistent with data in the clinical database. Uses the specified process to document and query any such discrepancies found with the appropriate party
- Creates adhoc data cleaning reports used to determine if a validated listing is required including creation of the specification for the validated listing (updates DVS with the listing requirements)
- Performs post-migration testing on screens, edit checks, matrices and role changes as required
- Runs data cleaning and/or status reports
Education
New York University
2002 - 2007
Bachelor's Degree in Related Science
Professional Skills
- Excellent verbal and written communication skills, including the ability to clearly describe critical technical CDM aspects to non-CDM staff
- Good organizational and planning skills. Ability for multiple project tasking
- Proven ability to work effectively in a team, including in a multinational one
- Fluent in English; good verbal and written skills
- Broad regulatory affairs experience - new marketing authorisations, renewals, variations (CMC, Safety and Labelling, Administrative), medical devices
- Base SAS programming experience
- Assist with system testing validation
How to write Clinical Data Associate Resume
Clinical Data Associate role is responsible for research, software, training, database, oncology, reporting, design, education, travel, events.
To write great resume for clinical data associate job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Clinical Data Associate Resume
The section contact information is important in your clinical data associate 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 Associate Resume
The section work experience is an essential part of your clinical data associate 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 associate 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 associate position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Clinical Data Associate resume experience can include:
- Communicate and present effectively
- Experience in developing database and validation specifications
- Considering 0-1year of experience
- Work with to set up, validate and maintain clinical databases in accordance with existing standards
- Demonstrate a general understanding of each assigned protocol, critical tasks and milestones
- Demonstrated knowledge of FDA, EMA, ICH guidelines and regulations covering clinical trials, statistics, and data management
Education on a Clinical Data Associate Resume
Make sure to make education a priority on your clinical data associate 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 associate 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 Associate Resume
When listing skills on your clinical data associate 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 associate skills:
- Effectively apply knowledge and skills in a highly organized fashion while
- Excellent speed and accuracy of keyboard skills. Effective oral and written
- Regulatory experience, or combination of higher education/less experience or substitution of equivalent relevant work experience
- Strong computer skills including EDC
- Exceptional organizational, interpersonal, and presentation skills
- Collaborate with CDM Team to generate validation and testing documentation
List of Typical Experience For a Clinical Data Associate Resume
1
Experience For Senior Clinical Data Associate Resume
- Responsible for ensuring clinical data are well-validated and ready for statistical analyses
- Assisting field clinical staff in collecting data to meet the protocol requirements in a timely manner
- Lead in the design and implementation of clinical data management process with vendors including data entry, data quality checking, data transfer and reporting
- Assist with all study start up activities including but not limited to User Acceptance Testing
- Provide study level metrics relating to eCRFs reviewed, Query status, Data Entry and Monitoring Status
2
Experience For Clinical Data Associate Process / Technology Resume
- Provides project-specific training to other Clinical Data Associates (CDAs)
- Generates and enters test data for user acceptance testing under guidance
- For paper studies, performs internal QC checks via listing output from database against CRFs and DCFs
- Coordinate and assist with Study Team line listing review meetings
- Liaises with other groups such as Clinical Programming (CP), Biostatistics and Clinical Operations
- For paper studies, performs internal quality control checks via listing output from database against CRFs and DCFs. Serves as QC Coordinator for paper studies
- Perform post-migration testing on screens, edit checks, matrices and role changes as required
3
Experience For Clinical Data Associate / Coordinator Resume
- Trains and mentors DM staff providing timely feedback to trainee and management as appropriate
- Provides EDC training to internal and external team members via webex
- Creates electronic storage media per SOPs for EDC studies
- Participates in internal meetings and internal/external audits as required
- Participates in customer and third party meetings distributing relevant information in advance, ensures minutes are promptly and accurately distributed to internal team for review and subsequent edits are applied in order to maintain established currency for sponsor distribution
- Files documentation the Data Management Study File (DMSF)
4
Experience For Clinical Data Associate Resume
- Maintains proficiency in Data Management systems and processes through regular trainings (CDA Knowledge College)
- Receives and enters lab normal ranges
- For paper studies, takes receipt of, and reviews, Data Clarification Forms (DCFs) that have been answered by sites and where appropriate, edits the Case Report Forms (CRFs) and database accordingly
- For Rave studies, performs DM quality review and/or other internal QC checks as required per applicable Electronic Data Capture (EDC) systems
- For paper studies, ensures all CRFs and DCFs received are returned for filing in the Document Control Room (DCR) per the Data Tracking Guidelines for the assigned projects
- Creates electronic storage media per standard operating prodedures (SOPs) for EDC studies
- Maintains proficiency in DM systems and processes through regular training courses (CDA Knowledge College)
- Participates in internal meetings and in internal/external audits as required
- Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s) and communicates status updates to the Project Manager (PM) and/or Biometrics Project Manager (BPM) as necessary
5
Experience For Senior Clinical Data Associate Resume
- Work experience in clinical data management at a pharmaceutical, medical device or CRO company
- Reviews and adheres to the requirements of study-specific Clinical Data Management Plans for
- Design easy to use case report forms (data collection sheets) to facilitate data collection for a clinical study protocol
- Enter data from clinical studies and address queries
- Develop specifications for automated edit checks
- Build clinical study databases and program automated edit checks
- Assist with Clinical Trial Data Management Clinical Trial documentation
- Participate in clinical database development
- Review and provide input from data management perspective on protocols
6
Experience For Clinical Data Associate Process / Technology Resume
- Work in conjunction with Clinical Research Associates, Clinical Project Managers, and others on the Clinical Affairs team on CRF design process utilizing existing data form standards
- Work closely with study project team to provide clinical study support with an emphasis on site management, device management and start-up activities
- In collaboration with Clinical, create CRF completion guidelines to be utilized by sites and clinical research associates
- Provide and work with EDC vendor to program CRFs and improvements to EDC
- Ensure quality data management activities – i.e., data review, query generation and resolution, generate status reports to clinical staff and management
- Create and maintain Data Management Plans, including, but not limited to: CRF flow, external data handling, SAE processing, coding, lock procedures, and archival procedures, collaborating with Clinical
- Create and maintain tools for tracking and inventory of CRFs
7
Experience For Clinical Data Associate / Coordinator Resume
- Develop guidelines for data entry
- Perform or oversee final archival of CRFs database
- Act as a point person and provide oversight for CRA data management activities
- Oversee delivery and shipment of items needed for orthodontists, general dentists
- Participates in data collection and organization, literature reviews, structured interviews, provides basic data analysis and interpretation
- Maintains clear and accurate records, inventories and logbooks
8
Experience For Clinical Data Associate Resume
- Understand, update, and instruct staff on Standard Operating Procedures (SOPs) for hard copy quality assurance (QA), data entry, and data QA, per guidance of the Research Data Coordinator (RDC) and Scientific Directors
- Complete checks of existing tracking systems (for recruitment, consent, and questionnaire completion), resolve discrepancies/errors, and create/update formulas for tracking
- Support of all data management activities; user acceptance testing (UAT), database cleaning and lock activities including review of data management plans, reviewing and processing clinical trial data to ensure completeness, accuracy and consistency of clinical trial databases
- Review and issue queries for CRF data (based on edit checks, manual review and from the Halozyme internal team reports and listings)
- Maintain all the necessary documentation to support accuracy and integrity of clinical databases
- Support interactions between Halozyme, CRO’s and outside vendors (e.g. clinical local or central laboratories) on the collection, transmittal and transfer of study specific laboratory data
9
Experience For Senior Clinical Data Associate Resume
- Participate in cross functional team meetings and communicate with all departments regarding project statuses/issues
- Work with data management, biostatistician and SAS programmers to harmonize data collection, compile and maintain SAS data standards, including CDASH CRF collection, CRF specification guidelines and edit check documents
- Take a supporting role in the review and query of clinical data. This includes participation of the critical review of data-populated tables, figures, and listings as part of the database clean-up and prior to database lock
- Participate and take leadership role for data management in project team meetings to discuss evolution and issues for ongoing registry program
- Foresee data management project issues needing to be brought to the attention of management, or other functional departments
- Collaborate with programming team to define requirements for data listings to utilize in manual data review
10
Experience For Clinical Data Associate Process / Technology Resume
- Assure regulatory compliance of vendors and investigational sites with company SOPs, FDA and ICH guidelines, and other applicable regulations and guidelines
- Work with the data management team on various other tasks as needed
- Oversee the Functional Service Provider (FSP) in data validation engagement to ensure clinical data are processed according to the Data Review Guidelines (DRGs) and Standard Operating Procedures (SOPs)
- Lead the project team in the development, review and approval of Case Report Forms (CRFs)
- Coordinate with highly motivated and experienced Data Management and Site Operations team to identify potential problems with data collection and data quality and suggest methods for improving processes and workflows to ensure good quality data
- Collaborate with data management team in the development of global, inter-departmental harmonized SOPs, and registry specific guidelines for patient workflow (enrollment, transfer) and processing clinical data
- Collaborate with data management team and other functional departments to define and develop operational type reports to assist with data exploration and metrics. Review data listings to resolve data trends
- Create, implement and maintain data management procedures and workflow documentation, to include, but not limited to: Data Review Guidelines, eCRF Completion Instructions, Data Validation Plan and Data Management Plan
List of Typical Skills For a Clinical Data Associate Resume
1
Skills For Senior Clinical Data Associate Resume
- Experience with Merge eClinicalOS (now IBM Clinical Development)
- Experienced with EDC database development/ startup
- Validation and verification of EDC systems
- 1 to 3 years Clinical Data Management experience
- Clinical Database use experience
- Experience in research required
2
Skills For Clinical Data Associate Process / Technology Resume
- Previous relevant EDC experience
- Experience with Electronic Data Capture (EDC)
- Experience in comparable position within the pharmaceutical, biotech or CRO industry
- A strong appreciation of the requirements, timelines and processes and changes in the EU
3
Skills For Clinical Data Associate / Coordinator Resume
- Previous experience with clinical trials dossier compilation and submissions in EU and third countries
- Excellent English language. Ability to author various Regulatory documents in English
- Experience in comparable position within the pharmaceutical, biotech or CRO industry
- Experience with Reporting Tools (e.g., BOXI, SAS, Business Objects)
- Experience in writing SOPs, Work Instructions, Data Management Plans and Guidelines
4
Skills For Clinical Data Associate Resume
- Experience with Electronic Data Capture (EDC)
- Experience with Medidata RAVE including study start up, conduct data review and database lock
- Run SAS programs, review SAS logs, and generate output. Program SAS Non System Edit Checks (NSECs) and/or SAS Data Listings as appropriate for SAS skill level
- Identifying, tracking, and resolving basic queries
- Working knowledge of word-processing, data management software (EDC, IXRS, ePRO, and other remote capture systems used in the industry)
- Reviewing documentation and requirements for new projects and anticipating impact to Data Management (DM) standards/processes
5
Skills For Senior Clinical Data Associate Resume
- Collaborating with appropriate project teams as needed to stay abreast of and changes that could affect data collection, cleaning and/or transfers
- Utilizing reports to track study progress and ensure timeliness and quality expectations are met
- Exploring new opportunities to add value to the organization
- Assist RDC with cleaning of data and detection of missing data, including identifying, removing, and resolving errors encountered
- QA of electronic data capture programming (e.g., format design, usability, testing skip patterns, checking data coding, etc.)
- Assist RDC with data export process for data collected electronically, including QA of syntax for import and recoding and troubleshooting PDF/web based errors
- Develop training materials and provide training to Site Operations personnel
6
Skills For Clinical Data Associate Process / Technology Resume
- Knowledge and understanding of DM Lifecycle associated with P1-P3 studies, including pivotal, blinded, and randomized trials
- Create annotated case report forms including variable names and coding instructions
- Provides input into the DVS including creation of edit checks for assigned forms including any post-production updates to the DVS and listings
- Performs QC of DMSF after QuickStart® Camp (QSC) and ongoing during the study conduct
- Help create scope scenarios and negotiate outcomes with study teams while taking into account the cost and value of scenarios
- Facilitate/assimilate integration of disparate data sources into datasets for decision making
- Multitask under tight deadlines while providing attention to detail
- Proficiency in navigating MS Windows, as well as use of MS Word, Excel, and
- Proficiency with word processing software and relational databases
7
Skills For Clinical Data Associate / Coordinator Resume
- Travel 1-3 weeks a year for offsite training, meetings, site visits, conferences, or symposia
- Work to develop edit checks and develop queries for assisting the Clinical Research team
- Perform user acceptance testing (UAT) of database and EDC
- Generate queries to resolve data issues and apply corrections to database, working with the clinical research associate
- Perform reconciliation of adverse events with serious adverse events database according to established guidelines
- Understand the fundamentals of merging external data with the CRF data
8
Skills For Clinical Data Associate Resume
- Assist in writing clinical study reports
- Assist in implementing routine clinical research projects and standards. Identifies, tracks, and resolves routine queries
- Verifies and corrects data entry for research projects, supports senior staff in quality control and provides trouble shooting
- Prepare and improve training materials for hard copy QA, data entry, and data QA and complete secondary QA checks of staff’s finished tasks
- Update dataset properties across multiple databases and maintain database merging capability
- Construct and QA syntax (under supervision of RDC) written for dataset creation, dataset updates/revision, and data cleaning
- Technical knowledge to develop requirements and/or study/project deliverables (i.e. SAS,Oracle)
- Ensure that data acquisition, database design, and observed dataset requirements are reflective of specific protocol objectives
- Specifies the data collection tools and technology platforms for the trial/program
9
Skills For Senior Clinical Data Associate Resume
- Drive standards decisions, implementation and compliance for the study/program
- Utilize therapeutic knowledge and possess a deep understanding of the technology used to review data to ensure database deliverables are consistent and accurate
- Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to data deliverables
- Min of 1 year Data entry experience; preferably on clinical database systems
- Knowledge of clinical data, ICH/Good Clinical Practices and medical terminology
- Experience with Electronic Data Capture (EDC)
- Experience in Clinical Trials
- Develop data management QC plans and quality control checks for the processing of clinical data
10
Skills For Clinical Data Associate Process / Technology Resume
- Create User Acceptance Test (UAT) Plans, Test Scripts and execute testing
- Collaborate with the Medical Director and project team to develop Case Report Forms
- Track individual project tasks and overall project timelines
- Review and approve vendor contracts, change orders and invoices
- Computer literacy and proficient in Microsoft Office tools
- Graduate in the biological sciences or related disciplines in the natural science / health care field
- Give presentations and updates on clinical projects
List of Typical Responsibilities For a Clinical Data Associate Resume
1
Responsibilities For Senior Clinical Data Associate Resume
- Oncology Data Review Experience
- Experience in CDM within clinical development
- Reviews queries and self evident corrections proposed by less experienced DM staff
- Perform data management tasks according to GCP, approved SOPs and protocol
- Maintain the following documents for the clinical database in Electronic Data Capture (EDC); database specifications, data validation (edit checks) specifications, report specifications and other functional specifications
- For paper studies, performs internal QC checks via listing output from database against CRFs and DCFs. Serves as QC Coordinator for paper studies
- Track and maintain project level documents in designated electronic storage space for compliance reviews
- Perform periodic QC of all reviewed and queried data
- Oversee query management, manual review, and all daily data management activities for assigned projects
2
Responsibilities For Clinical Data Associate Process / Technology Resume
- Manage/coordinate work performed by vendors/CROs as appropriate to ensure quality of product
- With minimal oversight, develop 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
- With minimal oversight, lead data cleaning activites such as but not limited to Study Team data reviews, Non-system Edit Check Output review, SAE reconciliation, and non-CRF data reconciliation
- Demonstrates "everyday leader" qualities
- Post queries on behalf of study team members and follow to resolution
- Develop and run data review reports through BO4 and J-Review
3
Responsibilities For Clinical Data Associate / Coordinator Resume
- Thorough knowledge of FDA regulations and ICH GCP guidelines and the DM Lifecycle
- Reviews and adheres to the requirements of study-specific DMP for assigned project(s) and updates as required
- Creates and enters test data for edit checks
- Create adhoc data cleaning reports used to determine if a validated listing is required including creation of the specification for the validated listing (updates DVS with the listing requirements)
- Attend in-process review meetings
4
Responsibilities For Clinical Data Associate Resume
- Trains project team in project specific requirements
- Serves as a platform or process-specific Subject Matter Expert (SME)
- Review and provide input from data management perspective on protocols.·Work in conjunction with Clinical Research Associates, Clinical Project Managers, and others on the Clinical Affairs team on CRF design process utilizing existing data form standards
- Experience in clinical data
- Experience in device or pharmaceutical clinical trials
5
Responsibilities For Senior Clinical Data Associate Resume
- Ensuring completeness, correctness and consistency of clinical data and data structure
- Independently lead data cleaning activities such as but not limited to Study Team data reviews, Non-system Edit Check Output review, SAE reconciliation, and non-CRF data reconciliation
- Develop and implement Quality Control guidelines/instructions
- Creates electronic storage media per SOPs for Electronic Data Capture (EDC) studies
- Define Lilly business requirements for the study/program for vendors to deliver
- Ensure vendor performance for the program-level flow of data, including across niche vendors and niche data sources (pharmacokinetic, immunogenicity, biomarker)
6
Responsibilities For Clinical Data Associate Process / Technology Resume
- Assisting in the implementation of clinical data management process with vendors including data entry, data quality checking, data transfer, reporting, backup, and recovery
- Assisting in the preparation of CRF/eCRF data collection through the regulatory approval process
- For paper studies, takes receipt of, and reviews, Data Clarification Forms (DCFs) that have been answered by sites and where appropriate, edits the CRFs and database accordingly. Submits copies of the DCFs to sponsors as necessary
- Previous EDC experience
- For Rave studies, performs DM quality review and/or other internal QC checks as required per
7
Responsibilities For Clinical Data Associate / Coordinator Resume
- For paper studies, ensures all CRFs and DCFs received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned projects
- Write and produce reports and queries
- Assist and support statistician with data analysis
- High proficiency with MS Office (Word, Excel, Powerpoint), email, internet
- Knowledge of the pharmaceutical, biotechnology, biomedical, and/or clinical research industry
- With clinical trial design and analysis
- Give presentations and updates on clinical projects·
- Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database. Based on this review, queries or applies self-evident corrections or other global rulings permitted in cases where queries are not required, per the DVS and/or Data Management Plan (DMP) for the assigned projects. Resolves answered queries and re-queries where appropriate
- Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database. Based on this review, queries or applies self-evident corrections in cases where queries are not required, per the DVS and/or Data Management Plan (DMP) for the assigned projects. Resolves answered queries correctly and re-queries where appropriate
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