Lead Data Manager for Clinical Trials

PSI CRO•Mississauga, ON

1d•CA$115,000 - CA$135,000

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, developing and reviewing data management plans and project-specific guidelines, coordinating user acceptance testing, developing data validation plans/edit check specifications, coordinating and supervising data entry, performing data validation including manual inspections and discrepancy resolution, handling non-CRF electronic data, performing database edits and manual CRF reviews, managing clinical database lock, coordinating processing and archiving of CRFs/queries, inputting into CRF design, developing CRF completion guidelines, coding medical data, SAE reconciliation, and reviewing electronic data transfer specifications. The role also includes liaising with the Document Center for TMF/eTMF maintenance, performing database QC checks, participating in audits and inspections, and training Assistant Data Managers and clinical teams. Additionally, the Lead Data Manager will prepare for and attend investigator meetings and client/vendor meetings.

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, including EDC development, data collection, cleaning, reconciliation, Database Lock, and generation of final deliverables.
Review study documents.
Develop and review Data Management plans and project-specific guidelines.
Coordinate and 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, discrepancy review and resolution, and query generation.
Handle non-CRF electronic data, including receiving, archiving, loading, and resolving reconciliation issues.
Perform database edits for paper CRF studies.
Conduct manual CRF reviews (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.
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 specifications.
Liaise with the Document Center regarding TMF and eTMF maintenance.
Perform and document database QC checks.
Participate in internal and client/third-party audits/inspections of Data Management.
Follow up on and resolve 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.