Job Purpose

The Senior Clinical Trials Manager will provide key oversight, guidance, and support for the operation and execution of clinical trials for Cytokinetics clinical program.

Responsibilities

• Manage various activities associated with multiple clinical studies in accordance with designated project assignments
• Use thorough knowledge of FDA regulations and ICH guidelines to ensure compliance with both during clinical trial conduct
• Lead significant Phase II or Phase III program with a focus on clinical operations
• Design 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
• Lead cross-functional study management team meetings, study operations team meetings, and teleconferences with study vendors
• Manage study-specific CROs and vendors and contract CTMs and CRAs as appropriate
• Perform independent monitoring of sites as required by needs of project
• Attend scientific meetings as a representative of Cytokinetics clinical operations team
• Provide critical insight regarding evaluation and selection of CROs and other outside vendors
• Coordinate 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
• Coordinate 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
• Collaborate with Finance, Clinical Outsourcing Manager, and line manager on vendor and study site budget tracking and compliance
• Use well-developed problem-solving skills to address needs of program and provides guidance to other lower level personnel
• Participate in interviews of Clinical Operations candidates (FTEs and contractors) and provides feedback to hiring manager

Qualifications

• BA/BS in science-related field with 8+ 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