The Senior Clinical Trials Manager will provide key oversight, guidance and support for the operation and execution of clinical trials for Cytokinetics clinical programs. The candidate will work under the supervision and guidance of the Director, Clinical Operations to ensure completion of the following clinical drug development activities:
- Independently manages various activities associated with multiple clinical studies in accordance with designated project assignments.
- Uses thorough knowledge of FDA regulations and ICH guidelines to ensure compliance with both during clinical trial conduct.
- Has experience as clinical operations lead on a significant Phase II or Phase III program.
- Independently designs study related documents (or sections therein) including but not limited to: clinical protocols, case report forms, site study manuals, project tools, monitoring plans, tracking tools, informed consent forms.
- Support of departmental functions for preparation and/or attendance at departmental meetings, clinical operations training and developmental activities as required and directed.
- Leads cross-functional study management team meetings, study operations team meetings, and teleconferences with study vendors.
- Manages study-specific CROs and vendors and contract CTMs and CRAs as appropriate.
- Performs independent monitoring of sites as required by needs of project.
- Attends scientific meetings as a representative of Cytokinetics clinical operations team.
- Adds critical insight regarding evaluation and selection of CROs and other outside vendors.
- Coordinates efforts in study start-up, including study feasibility, site selection, preparation and follow-up of site regulatory packages in coordination with other clinical operations staff and other Cytokinetics departments as appropriate.
- Coordinates efforts in all stages of study conduct (enrollment, follow-up, close-out) and oversees clinical operations team and CRO/vendors to ensure the study achieves its goals on time and within budget
- Works with Finance, Clinical Outsourcing Manager, and line manager on vendor and study site budget tracking and compliance.
- Uses well-developed problem-solving skills to address needs of program and provides guidance to other lower level personnel.
- Participates in interviews of Clinical Operations candidates (FTEs and contractors) and provides feedback to hiring manager
- BA/BS in science-related field. 7+ years’ work experience as a CRA or CRA/CTM combination of relevant related work experience.
- Strong communication skills (verbal and written).
- Well-developed strong problem-solving skills.
- Demonstrated thorough understanding of FDA regulations and GCP.
- Exceptional interpersonal skills with demonstrated successful team participation.
- Demonstrated skill in managing multiple tasks simultaneously, with attention to detail.
- Ability to work under pressure and deal with time demands; good time management skills
- Ability to appropriately assess prioritization of assigned activities.
- Ability to proactively identify issues and address with solutions-oriented approach
- Proficient in use of Microsoft applications such as Word, Excel, Power Point, etc.
- Ability to travel important as the position could require approximately 20% time spent in business travel.