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Reference Number:
MS-CTH-EHNJ
Job Description:
Our client is a major pharmaceutical company and they are looking for 2 Clinical Trial Heads for 6+ month position in East Hanover, NJ.
Positions available are 1) Nervous System - Potential Temp to Perm or 2) Basel
- Responsible for all operational aspects of 1 or more clinical trial(s) (Phase II through lifecycle management) under the leadership of Clinical Trial Head (CTH). Support all scientific aspects of clinical trial(s) as assigned. Responsible for program level activities as assigned.
2. Provide input and contribute to the development of protocols and related documents, in the ongoing scientific review of clinical data, and in trial data analysis, reporting and publishing.
3. Prepare training materials and presentations related to the planning and conduct of the trial.
4. Prepare clinical outsourcing specifications. Responsible for management of Contract Research Organizations ( CROs) and ensure adherence to scope of work within timelines and budget.
5. Manage interactions with Global Clinical Development Operations and other relevant functions including Drug Supply Management and Novartis local medical organizations.
6. Accountable for accuracy of trial information in all trial databases and tracking systems.
7. Support the development, management and tracking of trial budget working closely with the Therapy Area (TA) program operations group.
8. Participate in the organization and logistics of various oversight and Advisory boards; attend meetings.
9. Point of contact for managing/answering questions related to trial procedures and patients? eligibility.
10. Write CTT meeting minutes. May occasionally deputize for the CTH at Clinical Trial Team meetings. Participate in International Clinical Team meetings.
11. Contribute to program level activities (e.g., tracking of CD&MA brand-related publications, development of clinical sections of regulatory documents like Investigators? Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions).
12. Responsible for implementation of best practices and standards for trial management within the TA, including sharing lessons learned.
13. Contribute to talent and career development of TA staff through active participation in on-boarding, training and mentoring activities. May serve as faculty member for CD&MA training programs.
Skills: Involvement in cross-functional, multicultural and international clinical trial teams; demonstrated capabilities in leading specific trial related activities like planning, executing, reporting and publishing activities.
? Knowledge of Good Clinical Practice; thorough knowledge of clinical trial design; understanding of the overall drug development process.
? Knowledge of principles for trial budgeting.
? Basic knowledge of TA preferable.
Education: ? Advanced degree or equivalent education/degree in life science/healthcare required accompanied with ¡Ý 2 years experience in clinical research. or ? Bachelor degree or equivalent education/degree in life science/healthcare required if accompanied with ¡Ý 4 years experience in clinical research.
Qualified candidates should please send a MS Word copy of their resume to manisha@sunrisesys.com. PLEASE INCLUDE THE JOB REF # "CTH-EHNJ" IN THE SUBJECT LINE!
Experience Level:
4 Years
Requirements:
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