|
To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.
| Job #03507 |
 |
| About our client |
| Our client is a CRO. They specialize in clinical trials for diseases of the immune system. |
| Position |
Location |
| Executive Director of Clinical Trial Management |
Maryland |
| Salary |
| Highly competitive package, commensurate with experience |
| Responsibilities |
The Executive Director will provide leadership and oversight for group activities, including:
1) Mechanistic Study Project Management
- Developing mechanistic study protocols by defining specimen, blood and collection tube configurations, and providing operational cost projections and budgets (in collaboration with clinical trials, research, and finance groups)
- Keeping timelines for research studies, alignment of mechanistic studies with patient
- Assertive maintenance of sample inventory matrixes allowing for design and execution of mechanistic studies (with research and principal investigators)
- Collaborations - key contact for planning, monitoring progress and execution of studies
2) Site Operations and Compliance
- Oversight of specimen collection, shipping and tracking from sites to core testing laboratories and our central biorespository
- Site selection, initiation and training, developing and maintaining lab manuals
- Monitoring and supplying of collection tubes and reagents, insuring site compliance
3) Specimen Inventory and Data Management
- Managing of clinical data, configuration and training of specimen tracking applications, reconciling operational deviations with accountability for maintaining the quality and identity of specimen inventory and the associated experimental results
- Managing the contract with our biorepository and supporting all core operational processes
4) The incumbent will be expected to participate in developing and supporting network-wide project management platforms, strengthening processes for maintaining data quality and information sharing, and contributing to strategic resource and portfolio planning. |
| Requirements |
1) Successful candidate should preferably have an M.S. or Ph.D. degree in biological sciences, or PMP with at least eight years relevant work experience in clinical operations, project management and/or data management involving the planning, integrating and implementing laboratory based studies in clinical trials.
2) Experience from a CRO / pharmaceutical / biotech company is preferred; experience in an academic clinical trial center will also be considered. |
|
|
|
