Lead Data Manager for Clinical Trials

PSI CRO•Mississauga, ON

6d•CA$115,000 - CA$140,000

About The Position

The Lead Data Manager will be responsible for all data management activities in large, complex studies under general supervision, or working under minimal supervision on data management activities for small to medium sized projects. This role involves being the primary communication point for project teams and company departments regarding clinical data management, as well as the communication line for clients/vendors for all data management aspects of clinical projects and reporting. The Lead Data Manager will coordinate data management activities within clinical projects related to EDC development, data collection, cleaning, reconciliation, Database Lock, development of final integrated database, and generation of final Data Management deliverables. Key responsibilities include study document review, development and review of Data Management plans and project-specific guidelines, coordinating/performing user acceptance testing, development of Data Validation Plans/Edit Check Specifications, data entry coordination and supervision, data validation including discrepancy review and resolution, query generation and resolution, handling non-CRF electronic data, database edits, manual CRF review, clinical database lock, coordination and supervision of CRF/query processing and archiving, input into CRF design, development of CRF completion guidelines, coding medical data, SAE reconciliation, and review/approval of electronic data transfer specifications. The role also includes liaison with the Document Center for TMF and eTMF maintenance, performing and documenting Database QC checks, shared responsibility for audits and resolution of audit findings, training Assistant Data Managers, and project-specific training for investigators and clinical teams. Additionally, the Lead Data Manager will prepare for and attend Investigator Meetings and meetings/teleconferences organized by clients/vendors.

Requirements

College or University degree or equivalent combination of training and experience that presents the required knowledge, skills and abilities.
At least 3 years of experience of full scope of data management responsibilities in global EDC studies.
At least 2 years of experience using CDM/EDC systems (Medidata Rave or Oracle Inform preferable).
Organizational and managerial skills.

Nice To Haves

Project data management experience is a plus.

Responsibilities

Serve as the primary communication point for project teams and company departments regarding clinical data management.
Act as the communication line for clients/vendors for all data management aspects of clinical projects and reporting.
Coordinate data management activities within clinical projects related to EDC development, data collection, cleaning, reconciliation, Database Lock, development of final integrated database, and generation of final Data Management deliverables.
Perform study document review.
Develop and review Data Management plans and other project-specific guidelines and instructions.
Coordinate/perform user acceptance testing.
Develop Data Validation Plans/Edit Check Specifications.
Coordinate and supervise data entry, providing feedback to data entry personnel.
Perform data validation, including automatic and manual data inspections, review and resolution of data discrepancies/deficiencies, query generation and resolution, and provide feedback to clinical trial teams.
Handle non-CRF electronic data, including receiving, archiving, loading into study database, review and resolution of reconciliation issues, and providing feedback to vendors.
Perform database edits for paper CRF studies.
Conduct manual CRF review (non-medical checks).
Manage clinical database lock.
Coordinate and supervise the processing, dispatch, and archiving of CRFs/queries.
Provide input into the design of CRFs and other data collection forms; review Case Report Form design for accuracy and adherence to protocol.
Develop CRF completion guidelines.
Code medical data with coding dictionaries and review coding listings (requires medical/biology background and additional training).
Perform SAE reconciliation.
Review and approve electronic data transfer (import/export) specifications.
Liaise with Document Center regarding maintenance of TMF and eTMF.
Perform and document Database QC checks.
Share responsibility for preparation and attendance at internal and client/third-party audits/inspections of Data Management.
Share responsibility for follow-up on and resolution of audit findings pertaining to Data Management.
Train Assistant Data Managers.
Provide project-specific training to investigators and clinical teams in CRF completion.
Prepare for and attend Investigator Meetings.
Prepare for and attend meetings and teleconferences organized by clients/vendors.