Team Lead Clinical Data Management - Consultant

Tunnell Consulting

Seattle, WA

Expired: over a month ago Applications are no longer accepted.

Full-Time

Job Description

Tunnell Consulting is an employee-owned, life sciences management consulting firm. Known for solving complex problems in the life sciences, we support the mission and objectives of a variety organizations including biotech, pharma, the U.S. Government, foundations, public/private partnerships, investors, and emerging companies. The variety of clients and issues that we support give our team and our organization an ever-increasing breadth of experience to add to our deep industry and functional expertise. Headquartered in the Philadelphia area, we also have a presence in Washington DC, and Boston.

Tunnell Consulting has a need for an Independent Consultant to lead clinical data management for one of our clients. The consultant will be responsible and accountable for ensuring that the data activities related to studies are occurring in addition to overseeing and providing clinical data updates for senior management.

This opportunity is remote and will average 30-40 hours per week (6-12+ month assignment).

In the role as team lead of clinical data management, consultant will provide CRO oversight and implementation of the data management activities for clinical trials.

The consultant will be responsible for updating all patient data regularly on behalf of the client as well as data mining activities for the following items:

Dose adjustments/interruptions and document subsequent reasons.
3rd party reconciliation activities required/optional biomarker samples and PK samples/sample inventory documents.
Internal QC for the FDA IND Annual Report.
Be key contributor for study databases/CRF setup.
Protocol Review from a data management perspective.

Independent Consultant Experience:

BS/MS or equivalent
8-10 years of clinical data management experience
Certified Clinical Data Manager (CCDM)
Player / Coach responsibilities
Medidata Rave

Tunnell is proud to be an Equal Opportunity / Affirmative Action / Female / Minority / Disabled / Veteran Employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy, child-birth, or related medical conditions), national origin, ancestry, age, disability, family care status, veteran status, marital status, military status, sexual orientation, gender identity, or any other characteristic protected by law. Tunnell makes reasonable accommodation for persons with disabilities to apply for employment.

Please be advised that Tunnell resources are required to comply with all client COVID-19 requirements. This may include a requirement to be fully vaccinated against COVID-19, in accordance with the CDC guidelines and subject to legal requirements. Please contact Tunnell's Human Resources department if you would like to discuss any questions or concerns.