Clinical Trials Manager
Cytokinetics - South San Francisco, CA

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We are currently seeking a Clinical Trials Manager to join our Clinical Operations group.
*(Title will be commensurate with experience (Clinical Trials Manager-Sr. Clinical Trials Manager).

Position Purpose:

Provide key clinical support for the operation and execution of clinical trials for Cytokinetics clinical programs.

Major Responsibilities/Accountabilities:

The Clinical Trials Manager will work under the supervision and guidance of the Director, Clinical Operations to ensure completion of the following clinical drug development activities:

Essential functional duties of the position

· Requires minimal supervision to manage 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 had experience as clinical operations co-lead/lead on a significant Phase II or Phase III program.
· Independently designs study related documents including but not limited to: clinical protocols, case report forms, site study manuals and 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 study management team meetings and teleconferences with study vendors.
· Manages study-specific CROs and vendors and contract CRAs as appropriate.
· Performs monitoring of sites as required by needs of project with minimal guidance or supervision.
· Attends scientific meetings as a representative of Cytokinetics clinical operations team.

Other responsibilities/accountabilities (secondary functions)

· Adds insight regarding evaluation and selection of CRO’s, contractors 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.
· Works with Financial Operations Coordinator on vendor and study site budget tracking and compliance.
· Uses well-developed problem-solving skills to address needs of program and may provide guidance to other lower level personnel.

Job Requirements:
Knowledge/Skill Requirements:

· BA/BS in science-related field with a minimum of 4 years years work experience as a CRA or CRA/CTM combination of relevant related work experience.
· Excellent written and verbal communication skills required.
· Demonstrated thorough understanding of FDA regulations and GCP.
· Well-developed and strong problem solving skills.
· Exceptional interpersonal skills with demonstrated successful team participation.
· Demonstrated skill in managing multiple tasks simultaneously, with attention to detail.
· Proficient in use of Microsoft applications such as Word, Excel, Power Point, et c. Ability to travel important as the position could require approximately 25% time spent in business travel.

Now is the perfect time for you to consider a move to Cytokinetics where you can put all of your skills to maximum use. You will enjoy a truly unique culture as well as a competitive benefits program.

Cytokinetics is an Equal Opportunity Employer

Cytokinetics - 2 years ago - save job