91 applicants

Company

Cytokinetics · 14 hours ago

Contractor - TMF Manager

Remote - United States

Contract

Remote

Senior Level

5+ years exp

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BiopharmaBiotechnology

H1B Sponsor Likely

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Responsibilities

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 stakeholders.

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 monitoring 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 required.

Stay 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

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

TMF managementETMF AdministratorVeeva Vault TMFRegulatory inspectionsCDSIC Trial Master FileClinical PracticeICH guidelinesDocumentation PracticesCross-functional collaboration

Required

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.

Preferred

Bachelor’s Degree preferred

Company

Cytokinetics

Cytokinetics is a biopharmaceutical company developing therapies for debilitating diseases.

Founded in 1998

South San Francisco, California, USA

201-500 employees

http://cytokinetics.com

H1B Sponsorship

Cytokinetics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2023 (1)

2022 (6)

2021 (8)

2020 (4)