The Clinical Trial Manager- Gen Med Biotech division specifically NASH Therapeutics is responsible for the delivery of all clinical aspects of the study. The CTM oversees the clinical portion of the budget, develops monitoring plans & tools, trains CRAs, drives enrollment and study start-up activities, reviews trip reports, implements corrective and preventative action plans, liaises with the Sponsor, vendors and cross-functional teams, identifies and mitigates risks that may impact clinical delivery, and provides reporting and metrics on all clinical activities. The CTM will also participate in Sponsor, Investigator and bid defense meetings.
- Minimum Qualification: Degree
- Experience Level: Senior level
- Experience Length: 10 years
- 4-6+ years in a Clinical Trial Management position at a CRO or Pharmaceutical Organization, Required
- Bachelor’s degree in a health, life sciences or other relevant field of study, required
- 10+ years of relevant experience, required
- 2+ years monitoring experience, strongly preferred
- Experience in managing complex or global trials, preferred
- Minimum 1-2 years of experience leading Oncology cellular therapy trials, strongly preferred.
- Experience should include oversight of clinical trials using genetically-modified or somatic cell adoptive transfer in either autologous and/or allogeneic settings where cellular product logistics management was used.
- Experience in managing all trial components (start-up to database lock), preferred
- Experience in coaching/mentoring other CTMs, leading a team of CTMs, participating in departmental initiatives, preferred
- English fluency (ability to read, write, speak), required
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