Clinical Trial Operations Manager V Job Responsibilities
Education & Qualifications
- Provides input into identifying implications of study progress on overall timeline goals and conduct plans.
- Provides input into content and execution of investigator meetings and may present selected topics. With oversight, develops informed consent form and coordinates input. With oversight, provides point of contact for site questions relating to study conduct issues.
- Participates in the implementation of key organizational process improvement initiatives.
- Responsible for serving as clinical trial leader for a large-scale multi-country trial (Phases I-IV).
- Responsible for protocol preparation, generation of manuals for trial support committees and other trial documentation.
- Lead the multi-disciplinary team responsible for study completion. Writes and reviews abstracts/manuscripts, etc. for presentation/publication at internal/external meetings.
- Bachelors level degree/RN (or equivalent)
- Experience in Clinical Trials or Clinical Project management.
- Requires strong project management skills for clinical trials including - CRO oversight, Timeline Management and Risk Management
- Will be supporting a Lead Manager but must have direct trial / project management experience
- Experience with Investigator Sponsored Trials is a plus but not required
- Experience: 12+ years
- Certifications & Licenses: RN
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.