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, tr... more details
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class 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.
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
Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the service line and location where this position may be filled.
Salary Pay Range
$153,000—$186,000 USD
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 our General Data Protection Regulation (GDPR) policy PRIOR 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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