Lead Clinical Data Manager
Location: Foster City, CA
Name: Nicole Foster
Analysts International (AIC) has been engaged to identify a Lead Clinical Data Manager for a major research and pharmaceutical
company. The requirement entails:
1) Lead clinical data manager with 3 -5 years of Sponsor or CRO or Academic experience
2) Project management experience of clinical trials
3) Understanding of clinical data management processes
4) Communication with cross-functional study team members
This role will immediately assume biomarker data management responsibilities for representing biomarker data management at the biomarker Sub Team (BST) meetings. The candidate will also be responsible for providing oversight to studies that fall within the BSTs. The selected candidate will manage biomarker data in various stages, from planning, to set-up, conduct, closeout, and archiving, in high volume, while maintaining a high level of data quality by leveraging and adhering to standard data structures and corresponding standard edit checks and review listings. The selected candidate may also manage and lead in the design and implementation of biomarker data management processes with vendors, ensuring completeness, correctness, and consistency according to the standards. This role has a high degree of collaboration with the Biomarker cross-functional team members, study team members and other biomarker Clinical Data Associates.
The ideal candidate should possess a BS degree or higher in a Biomedical Science or equivalent and minimum 3 years of relevant clinical data management experience and preferably along with biomarker or laboratory background and experience in a CRO or bio/pharmaceutical setting.
Essential Functions: Works collaboratively with Biomarker Clinical Operations team members, Biomarker Scientists, Biomarker Statistical Programming group, Biomarker Biostatistics group, Biomarker Clinical Programming group, Biobanking and Sample Management group, and lead study clinical data associate and cross-functional study team members to meet project deliverables and timelines for biomarker data acquisition, quality checking and reporting. Demonstrate a general understanding of each assigned protocol, critical tasks and milestones. Ensure completeness, correctness and consistency of routine clinical data and data structure.
Responsibilities include: assisting in the developing the data transfer specifications, the data mapping specifications, the data quality review plan and the data validation specifications, vendor management, data review and data reconciliation. Assist in implementing routine clinical research projects and standards. Identifies, tracks, and resolves routine queries. Utilizes routine reports to track study progress and ensures timeliness and quality expectations are met.
Knowledge and Skills:
3 years of experience and a BS degree.
1 year of experience and a MS degree or PhD.