12 Jun
Contract - Manager, Clinical Data Management
Vacancy expired!
- Establishes Data Management strategy at the project and/or study level for a smaller number of projects/studies with less complexity.
- Proactively identifies and manages risks at the project and/or study level for a smaller number of projects/studies with less complexity.
- Plans and directs the conduct of Data Management activities for assigned projects/studies through outsourcing (e.g., study startup, study conduct, study closeout, and reporting).
- Provides oversight for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (Google Cloud Platforms), applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.
- Ensures Data Management deliverables meet/exceed project/study team expectations regarding quality, time, and cost and that Data Management documentation is filed/archived according to applicable company and regulatory requirements. Able to support BLA or other regulatory submission efforts.
- Data management and/or related industry work experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO).
- 5+ years data management and/or related industry work experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO)
- Candidate needs to have strong verbal/written skills, analytical, organizational, and interpersonal skills and is able to work effectively with people at different levels and from different disciplines and cultures.
- Candidate possesses a working knowledge of clinical operations and relevant regulatory requirements.
- Candidate has moderate skills in continuous improvement, project management, change management, and risk management.
- Candidate does not specifically need oncology experience (other therapeutic area is fine).
- Health insurance
- Casual Dress code
- 401k match
Vacancy expired!