Contract – Trial Master File (TMF) Manager

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.

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.

As the Contract Trial Master File (TMF) Manager, you will lead the day-to-day oversight and strategic management of study-specific TMFs to ensure ongoing inspection readiness across Cytokinetics’ clinical portfolio. You will serve as the primary TMF subject matter expert (SME) and key liaison between Clinical Operations, other CK Department Leads, and external CRO partners—driving TMF governance, process consistency, and quality across all phases of the study lifecycle.

This role is ideal for a detail-oriented and proactive professional who thrives in a fast-paced environment, has strong cross-functional communication skills, and can balance operational execution with strategic oversight. 

Responsibilities:

TMF Oversight

• Review and approve all applicable TMF Plans (e.g., TMF Index, internal/external TMF Plan, Migration Plans)’

• Drive adherence to Cytokinetics’ TMF SOPs, policies, and regulatory requirements.

• Oversee setup, maintenance, transfer, and archival of TMFs in compliance with study timelines.

• Perform oversight and quality review of eTMF documents uploaded into the Cytokinetics (CK) eTMF.

• Identify and mitigate TMF-related risks, quality issues, and compliance gaps; initiate or support corrective and preventive actions (CAPA) as needed.

• Support inspection preparation activities, including document retrieval, audit trail verification, and readiness assessments.

TMF Reviews & Quality Management

• Lead or coordinate periodic TMF reviews to ensure TMF completeness, timeliness, and quality across assigned studies.

• Facilitate TMF Index update meetings, TMF Reviews, and related Module Training sessions for study teams and partners.

• Conduct ongoing quality control (QC) of eTMF documents for accuracy, metadata compliance, and completeness.

• Maintain comprehensive tracking of TMF quality issues and ensure all queries are addressed in a timely manner.

• Provide regular TMF status and compliance reports to the Study Lead and key stakeholders.

• Review and approve all applicable TMF-related plans, including migration and archival strategies.

• Monitor TMF metrics, KPIs, and dashboards; proactively identify risks and escalate as needed to ensure ongoing inspection readiness.

• Participate in continuous improvement activities to enhance eTMF processes, templates, and system functionality (e.g., Veeva Vault TMF).

Functional Area Engagement & Governance

• Serve as the primary TMF point of contact for assigned studies, collaborating closely with Clinical Operations, Regulatory, Data Management, and CRO/vendor partners.

• Act as TMF business process SME, providing operational experience on TMF related process to internal and external TMF stakeholders

• Facilitate and document eTMF status calls to discuss TMF progress, issues, metrics, and other key updates.

• Lead or support TMF governance forums (e.g., TMF Strategy Meetings, TMF Educational Workshops, Vendor Oversight Meetings).

• Clarify functional document ownership, submission expectations, and TMF Index alignment with study teams.

• Provide TMF process training and mentorship to internal and external stakeholders to promote compliance and consistency.

• Prepare and maintain agendas, minutes, and action logs for all TMF-related meetings.

• Stay current on global regulations (FDA, EMA, MHRA, PMDA) and evolving industry standards, including CDISC TMF Reference Model, ALCOA+, ICH E6(R2), GCP, and GDP.

Qualifications

• Bachelor’s Degree preferred

• 5+ years’ experience managing or supporting TMF activities for clinical research/ biotech/ CRO company – preferably within a role seated in a records/ document/TMF Management department

• 1+ years of experience serving as eTMF Administrator – preferably Veeva Vault TMF experience.

• Experience in managing TMF documents during regulatory inspections

• Working knowledge of CDSIC Trial Master File Reference Model and ALCOA+ standard, Good Clinical Practice, Good Documentation Practices, and International Council for Harmonization E6 (R2) guidelines

• Working knowledge of applicable FDA, Canadian, EU, and ICH guidelines related to clinical trial and eTMF management.

• Ability to multi-task and manage several projects in parallel while paying attention to detail

• Strong critical thinking skills and ability to contribute creative yet practical solutions to problems

• Proactive, self-motivated, excels at cross-functional relationship building and can work independently with minimal supervision.

*This is a W-2 contract position.

#LI-REMOTE

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 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.

Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers

Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.

Here are some ways to check for authenticity:

• We do not conduct job interviews through non-standard text messaging applications

• We will never request personal information such as banking details until after an official offer has been accepted and verified

• We will never request that you purchase equipment or other items when interviewing or hiring

• If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at [email protected]

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer