Experienced Clinical Study Manager (Specialty Pharma) – Direct Hire/Top $$
Our client, an RTP-area pharmaceutical company in high growth mode, is actively recruiting for a highly capable and self-directed Clinical Study Manager to join its R&D team.
This company is experiencing exponential growth. They are preparing for the commercial launch of one product and are developing several others – primarily in rare disease.
It is essential that they have an experienced, knowledgeable and quality-driven team to drive Clinical Research. This CSM will play a key role.
This is a Direct Hire role and an immediate need. Company will pay generously to attract and retain a star.
Key things to note:
- These are global programs – ranging from Phase I thru III. Broad-based exposure will be important
- This will be an all-encompassing role driving the strategy and tactics for assigned study. Extensive experience planning, and then executing, clinical studies will be essential
- Company relies heavily on CROs. Right candidate will be accustomed to directing and overseeing the work performed by CROs. Bkgd working for a sponsor is strongly preferred
- This is an emerging company in which structure and strategies are still being developed. Right candidate will enjoy the building process and bring a process-improvement mindset every day.
This CSM will oversee all aspects of study design, from analysis and reporting, document creation, vendor selection, and oversight, to site-monitoring and study budget development and tracking. We seek a versatile Study Manager whose clinical research knowledge is complemented by practiced and proven Project Management capabilities.
Specific duties will include:
- Lead the start-up, execution, and closeout of multiple studies (US or overseas)
- Participate in vendor selection for clinical research units, bioanalytical laboratories, statistical support and case report forms/data management services. Manages vendors involved in studies.
- Generate and/or review study plans and documents (e.g. Informed Consent Forms, CRFs, Monitoring Plan and associated tools, Patient Information Sheets,) and coordinate translations as needed.
- Lead or contribute to integrated clinical study team meetings to ensure high scientific, ethical and regulatory standards, and expeditious registration submissions worldwide
- Works efficiently with internal regulatory, CMC, and clinical trial supplies, project management, and quality personnel to seamlessly meet key study milestones
- Oversee study related site management and monitoring activities
- Ensure monitoring visits are scheduled and reports submitted and finalized, provide review of monitoring visits reports
- Contribute to or provide proactive solutions to study-related issues
- Works to ensure TMF and other study files are kept up-to-date and inspection ready for regulatory documents
Ideal candidate will offer a related degree and 4+ years of clinical study management experience including site, CRO and study oversight. Other priorities include:
- Broad and deep knowledge of Clinical Operations, including extensive exposure to all functions, noted above including writing study plans, study start-up, document design, etc.
- Global trial exposure
- Outstanding project management skills
- Experience working for a sponsor/pharma
- Phase I experience and monitoring background, preferred
In addition, we seek a very sharp, knowledgeable and take-charge professional who will work exceedingly well in a dynamic and collaborative setting; One who can gain the respect and cooperation of all stakeholders in order to achieve shared success.
This is an immediate need. Please forward Word resume for prompt consideration. Local candidates only.