Clinical Trials Manager I

The Clinical Trials Manager I (CTM I) will provide operational support and coordination for the planning, execution, and oversight of clinical trials for Cytokinetics clinical program. Working under the guidance of senior team members, the CTM I ensures that clinical studies are conducted in compliance with regulatory guidelines, internal SOPs, and timelines. 

Responsibilities 

• Manage various activities associated with multiple clinical studies in accordance with designated project assignments 
• Apply working knowledge of FDA regulations and ICH guidelines to ensure compliance with both during clinical trial conduct 
• Support significant Phase II or Phase III program with a focus on clinical operations 
• Participate in the 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 
• Participate and support the conduct of cross-functional study management team meetings, study operations team meetings, and teleconferences with study vendors 
• Manage study-specific CROs and vendors including but not limited to coordinating shipment and tracking of study-related materials to and from investigational sites, vendors, and central labs. 
• May support co-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 oversee 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 the program and provides guidance to other lower level personnel 
• May participate in interviews of Clinical Operations candidates (FTEs and contractors) and provides feedback to hiring manager 
• Maintain TMF documentation quality in coordination with Clinical Trial Assistants and TMF leads 

Qualifications 

• BA/BS in science-related field required.  
• 1-3 years of experience in clinical research (e.g. CRA, Clinical Trial Associate, or project support roles); sponsor-side experience preferred. 
• Strong written and verbal communication skills  
• Strong problem-solving skills 
• Basic  understanding of ICH-GCP and FDA regulatory requirements 
• 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 

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