Description
Senior Clinical Data ManagerA growing oncology focused pharmaceutical client of mine in South San Francisco is urgently looking for a Senior Clinical Data Manager to join their team. This is initially a one year contract-to-hire position. This is a lead position and they would like someone to have a minimum of 5+ years of experience in the industry, but preferentially 10.
Senior Clinical Data Manager Duties
SUMMARY:
Designs, implements and maintains clinical trial database for new and ongoing clinical research studies. Manages clinical database activities including: archiving of clinical data and clinical study databases, security administration, electronic data received from clinical trial sites and vendors, and the development of technical study documents such as annotated case report forms.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Provide a high level of expertise in data management to support clinical studies.
* Provide clear verbal or written information and hands-on support to project team members and to CROs related to CRF design, data quality, and reporting of study results.
* Manage data transfers with CRO's, SAE/AE reconciliation and Med DRA coding semi-automated processes.
* Support IND Reporting and the transfer, locking, and archiving of study databases. Manage scheduling and time constrains across multiple projects.
* Prepare recommendations for new or improved processes for data management and data flow.
EDUCATION/EXPERIENCE/SKILLS:
Education:
* BS/BA degree in related discipline and 6 years of related experience; or,
* Equivalent combination of education and experience.
Experience:
* Typically requires a minimum of ten years of related experience and/or combination of experience and education/training.
* Experience in Biotech/Pharmaceutical industry preferred.
* A minimum of 5 years of clinical data management experience is also required, some of which is preferred to have been in the pharmaceutical industry or clinical trials.
* Experience with electronic Clinical Database Management Systems is required and experience with electronic reporting applications preferred.
* Experience with electronic data capture (EDC) is preferred.
* Experience as a lead clinical data manager is preferred.
* Experience with oncology clinical trials is preferred.
* Experience with Phase III clinical trials is preferred.
If interested in this position, please apply to this position as soon as possible. This is a very urgent role and the hiring manager is trying to start interviews early next week.