Contract - Sr Clinical Trial Manager (CTM)
Locations: South San Francisco, California
Time Type: Full Time
Posted On: Posted 2 Days Ago
Job Requisition ID: R52
About Cytokinetics:
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 for treating debilitating diseases caused by impaired cardiac muscle performance. As a leader in muscle biology and mechanics, the company is advancing small molecule drug candidates specifically designed to impact myocardial muscle function and contractility.
Job Purpose:
The Senior Clinical Trials Manager (CTM) will provide oversight, guidance, and operational support for the execution of clinical trials within Cytokinetics' clinical programs. This role involves leading multiple studies while ensuring adherence to regulatory guidelines and clinical trial protocols.
Responsibilities:
Clinical Trial Management:
Manage activities associated with multiple clinical studies in accordance with project assignments.
Utilize thorough knowledge of FDA regulations and ICH guidelines to ensure compliance during clinical trial conduct.
Lead significant Phase II or Phase III clinical programs with a focus on clinical operations.
Study Documentation and Processes:
Design study-related documents including clinical protocols, case report forms, site study manuals, project tools, monitoring plans, and informed consent forms.
Support departmental functions including preparation for and attendance at clinical operations meetings and training activities.
Team and Vendor Leadership:
Lead cross-functional study management teams, operations team meetings, and teleconferences with vendors.
Manage CROs, vendors, contract CTMs, and CRAs specific to each study.
Perform independent site monitoring as required by the project.
Provide input on evaluation and selection of CROs and vendors.
Study Start-up and Conduct:
Coordinate study feasibility, site selection, and preparation of regulatory packages in collaboration with internal departments.
Oversee all stages of study conduct, including enrollment, follow-up, and close-out, ensuring achievement of goals on time and within budget.
Financial Management:
Collaborate with Finance, Clinical Outsourcing, and line managers on budget tracking and compliance with vendor and study site contracts.
Problem-Solving and Mentorship:
Apply well-developed problem-solving skills to address study needs and provide guidance to junior personnel.
Participate in candidate interviews for Clinical Operations roles and provide hiring feedback.
Qualifications:
Education:
Bachelor’s degree (BA/BS) in a science-related field required.
Experience:
8+ years’ experience as a CRA or CRA/CTM combination in clinical research.
Demonstrated expertise in FDA regulations, GCP, and clinical trial execution.
Strong communication (verbal and written) and interpersonal skills.
Proven ability to manage multiple tasks simultaneously with strong attention to detail.
Experience in leading cross-functional teams and working under time pressures.
Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
Skills:
Strong problem-solving and decision-making skills.
Ability to prioritize tasks effectively and use a solutions-oriented approach.
Exceptional team participation and collaboration abilities.
Travel:
Approximately 20% domestic and international travel may be required.
Pay Range:
In the U.S., the hiring pay range for fully qualified candidates is $105.00 - $125.00 per hour.
Base pay will consider internal equity, geographic region, job-related knowledge, skills, and experience.
Commitment to Diversity and Inclusion:
Cytokinetics celebrates diverse backgrounds and encourages candidates to apply even if they do not meet every qualification. Passion, innovation, and a focus on patient care drive the company’s mission.
Fraud Warning:
All legitimate offers from Cytokinetics will come directly from our official email domain (cytokinetics.com) after a formal interview process. Cytokinetics will not request banking information or ask candidates to purchase equipment during the hiring process. If you are unsure about the authenticity of an offer, please contact talentacquisition@cytokinetics.com.
Website: www.cytokinetics.com
Equal Opportunity Employer
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