LEAD CLINICAL DATA MANAGER

Name
E: @gmail.com | C:(000) 000-0000
Professional Experience
 8+ years of extensive experience in Clinical Data Management expertly gathering and analyze
data for highly confidential Clinical trial
 Successfully lead and managed Data Management activities for various projects in different phases
(Phase I, II and III) of clinical trials
 Experienced to work on EDC as well as paper-based studies.
 Proficient in managing the statistics for phase I, II and III clinical trial with therapeutic areas of Oncology,
 Efficient experience in managing CRO’s work, study start up, study conduct, and study close out
activities of clinical trials to deliver clean and quality data.
 Detailed Knowledge and data management experience in accordance with GCP, ICH guidelines and
FDA regulations and CDM standards like CDISC, CDASH & 21 CFR Part 11.
 Good experience in working with CRO- oversight/ vendors to ensure smooth study set up and
smooth study conduct, close-out, reviewing the performance, protocol deviation and maintaining
awareness of issues raised.
 Excellent CDM skills in leading the activities of setup, Conduct and Closeout phases of a project and
Medical coding activities.
 Expertise in data review process, data clean up and data quality analysis. Developed Case Report
Forms (CRF’s), Data management plans (DMP’s) and performed User Acceptance testing (UAT) for
multiple clinical projects in accordance to protocol specifications.
 Experience in working with various EDC databases like Oracle Clinical, Inform, Medidata Rave.
 Extensively worked on database validation, query/discrepancy management, edit checks creation, lab
data reconciliation, SAE reconciliation.
 Efficient under tight timelines and strict deliverables, ability to resolve issues and meet deadlines.
 Therapeutic experience in Cardiovascular disease, Respiratory disease, Oncology, Immunology,
Parkinson’s Disease, Cardiovascular, Vaccine, Rheumatoid Arthritis

Educational Qualification

 Bachelor’s in
 Master’s in

Technical Skills
 Database / EDC Systems- Oracle Clinical, Medidata Rave, Inform.
 Operating Systems -Windows and IOS (proficient in using MS Office Word, Excel, PowerPoint,
Access, Outlook etc.,)
 Programming -SQL, SAS.
 Activities -Query Management, Data Entry, and Data Analysis; Database testing, CRF &DCF
tracking & reports, CCI/CCG, UAT, Quality Control and locking databases.
 Guidelines- CDISC/CDASH, SDTM, MedDRA, WHODD, GCP/ICH and 21 CFR part 11.
Work Experience:
Confidential | Lead Clinical Data Manager | MM YYYY-Current

Responsibilities:
 Responsible for all phases, including preparation, set-up, initiation, conduct, database lock.
 Involved in database design and setup, independent review of CDM deliverables.
 Supported clinical trials for Contract Research Organizations (CRO’s) by providing accurate data.
 Developed and reviewed DMP, CRF Completion Guidelines (CCG) and other DM specific
documents.
 Oversee of data management CRO/service providers on assigned studies
 Responsible for discrepancy management, SAE reconciliation, and Lab réconciliation.
 Be responsible for identification of data handling processes for non-CRF data, including lab data and
image handling.
 Lead Case Report Form Design according to the protocol with all Study Team members using
established standards.
 Worked extensively on phase II and III Oncology therapeutic areas like breast cancer, and ovarian
cancer
 Leading and Coordinating the DM teams’ activities both internally and externally
 Responsible for ensuring the integrity of data and providing recommendations for corrective action
when necessary.
 Liaise with Biostatisticians regarding data validation and lock of the database, including
management of discrepancies.
 Meeting and coordinating with Data Operations team, functional leads, project managers with regards
to CDM, executing queries, inputs on project improvements
 Work effectively with international peers and sponsors as needed.
 Track project progress and issue status reports.
 Provide training on procedures and systems.
 Provide timely performance feedback to the Clinical Data Managers I and II.
 Coordinate the work of global staff assigned to the project.
 Ensure the achievement of key milestones relating to the function, such as completion of tasks
towards final database.

Confidential | Senior Clinical Data Manager | MM YYYY – MM YYYY

Responsibilities:

 Lead a large clinical study or a series of related studies with minimal guidance.
 Coordinated with database programming, medical coding, and statistical programming teams to
ensure study progression.
  Managed and monitored the progress of data management activities with CROs or other vendors on
assigned studies; build effective relationships with CRO / vendor counterparts.
 Reviewed protocols for appropriate data capture including electronic Case Report Form (eCRF)
design. Performed a detailed review of eCRF data requirements.
 Interacted with CRAs, programmers, study managers and statisticians in designing eCRFs and
creating the annotated eCRF and CRF completion guidelines.
 Lead the development of data edit check specifications and data listings.
 Coordinated the design and testing of Electronic Data Capture (EDC) systems according to
company standards. Able to resolve EDC system issues with team members.
 Develop or lead the development of the Data Management Plan (DMP) for a clinical study and
participate in regular team meetings and provide input when appropriate.
 Reviewed and provided feedback to the clinical team on other study documents e.g., Clinical
Monitoring plans, Statistical analysis plans and vendor specifications
 Performed reconciliation of header data from external data sources against the clinical database.
 Performed serious adverse event reconciliation activities according to SOPs and guidelines.
 Lead database upgrades/migrations including performing User Acceptance Testing
(UAT). Performed database lock and freeze activities per company SOPs.
 Be able to maintain study workbooks and data management file.

Confidential | Clinical Data Manager | MM YYYY – MM YYYY

Responsibilities:
 Provide input into the development of data management SOPs and processes. Write or review Data
Management work instructions and SOPs.
 Work with the Manager of CDM to create, modify and implement data management processes.
 Assists in the development of data management plan for study design and database content
development.
 Oversee all DM activities internally, coordinating with the CRO and external vendors
 Assisted in UAT testing of Medidata Rave EDC systems.
 Designed edit check and eCRF spécification documents.
 Involved in Phase I to III trials of various therapeutic areas such as Oncology, Anti-inflammatory,
Respiratory and cardiovascular related studies.
 Provided expertise in the data management area to study managers, statisticians, and
statistical/clinical programmers.
 Ensuring completion of all activities leading to the study database lock
 Developed DMP, CRF Completion Guidelines (CCG) and other DM specific documents.
 Managed the internal Data Management activities, coordinated with the CRO and External vendors
 Developed annotated CRFs.
 Write, review, and approve all required trial data management documentation.
 Provide leadership and may supervise data management staff as and when needed.
 Assume overall responsibility for the successful execution of the data management projects assigned.
 Serve as data management contact with the sponsor managing their expectations, noting and
responding to out-of-scope work.
 Confidential | Clinical Data Coordinator | MM YYYY – MM YYYY

Responsibilities:
 Designed Essential clinical documents (ICF, protocols, CRF, study Reports)
 Designed eCRF, edit check specifications and performed UAT in accordance with protocol
specification.
 Performed studies as per protocol requirements SOP, ICH, GCP and standard guidelines.
 Worked on Medidata Rave data base for Phase II and Phase III studies.
 Reviewed Query track report, SAE track report and raised questions during cross functional
meeting for unaddressed queries.
 Involved in designing of data management plan for EDC and Data transfer agreement for
transferring data from external vendor.
 Coordinated with team members and updated project data into Trial Master File to ensure GCP
compliance for audits and inspections.
 Develop and execute database queries and perform discrepancy management.
 Assist in developing data management process and procedure improvements.
 Assist with developing test cases and performing user acceptance testing of EDC systems.
 Created annotated CRFs based on the study protocol and CDASH requirements.
 Developed and reviewed data management plans and data validation plans.
 Made sure the data management process is meeting the ICH-GCP guidelines.