About the job
Cytokinetics is a late-stage 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 muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility.
As the TMF Manager Consultant, your role will coordinate the day-to-day operations of study-specific TMF management. This includes providing subject matter expertise and Clinical Operations Team support required to ensure the Trial Master File is inspection ready for appropriate studies at Cytokinetics. Your role and responsibilities are pivotal as the point of contact to the Clinical Operations team as well as outside contract research organizations used.
- Review and approve all applicable TMF Plans (e.g., internal/ external TMF Plan Migration plans, TMF Index)
- Participate in the Quality Control of documents (paper and electronic) submitted to the TMF
- Facilitate the review and submission of TMF records, as well as complete the archival process
- Support the coordination of the transfer of study-specific trial master files from the CRO
- Maintain awareness of study events and the associated documentation requirements through collaboration with Study Team
- Ensure study team compliance to Cytokinetics policies and regulatory requirements related to TMF to ensure TMF Inspection readiness in real time
- Act as TMF business process SME, proving operational experience on TMF-related processes to internal and external TMF customers.
- Identity and mitigate TMF-related risk and quality issues. Also, identify any corrective actions which must be addressed and assigned, collect missing and expired documents, and resolves TMF discrepancies
- Support the management of TMF-related activities (e.g., TMF Reviews, Document Issues, KPI, and metrics) throughout the lifecycle of an assigned study
- Assist in supervising and tracking clinical trial progress and providing status update reports and study metrics
- Assist in the planning and/or facilitating TMF Strategy Meetings, Vendor/CRO Meetings, TMF Educational Workshops/training, and investigator meetings and making presentations, as the need arises.
- Keep abreast of current FDA, MHRA, EMA, PDMA, and other local regulations relevant to clinical and regulatory document creation, processing, management, and archival.
- Support Inspection preparation activities – as required
- Prepare meeting agendas and minutes
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.
- Bachelor’s Degree preferred
- 5+ years’ experience leading 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 leading 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 lead several projects/studies in parallel while paying attention to detail
- Strong critical thinking skills and ability to supply creative yet practical solutions to problems
- Proactive, self-motivated, excels at cross-functional relationship building and can work independently with minimal direction.
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.
Cytokinetics is an Equal Opportunity Employer