Contract - Sr Clinical Trial Manager CTM

Cytokinetics is a latestage specialty cardiovascular biopharmaceutical company focused on discovering developing and commercializing firstinclass muscle activators and nextinclass muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.

At Cytokinetics each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious compassionate and collaborative individuals who are driven to make a positive impact.

Job Purpose

The Senior Clinical Trials Manager will provide key oversight guidance and support for the operation and 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 crossfunctional study management team meetings study operations team meetings and teleconferences with study vendors

• Manage studyspecific 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 startup including study feasibility site selection preparation and followup 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 followup closeout) 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 welldeveloped problemsolving 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 sciencerelated field with 8 years work experience as a CRA or CRA/CTM combination of relevant related work experience

• Strong communication skills (verbal and written)

• Welldeveloped strong problemsolving 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 solutionsoriented 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

Pay Range:

Our employees come from different backgrounds and we celebrate those differences. We are looking for the best candidates for our open roles but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team we would love to hear from you.

Please review ourGeneral Data Protection Regulation (GDPR) policyPRIOR to applying.

Our passion is anchored in robust scientific thinking grounded in integrity and critical thinking. We keep the patient front and center in all we do all actions and decisions are in service of the patient and their caregivers. We champion integrity ethics doing the right thing and being our best selves.

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Cytokinetics is an Equal Opportunity Employer