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