Source Job

US

  • Manage TMF documentation, quality control, user access, completeness checks, reconciliations, transfers, and archival activities.
  • Collaborate with content owners, CROs, and vendors to resolve quality issues and maintain inspection-ready trial documentation.
  • Support audits, inspection readiness, and oversight of CRO-owned TMFs in a remote contract role.

Veeva Vault GCP ICH Guidelines Microsoft Office

19 jobs similar to Sr. TMF Specialist - Contract

Jobs ranked by similarity.

$85,000–$115,000/yr
US

  • Support Clinical Trial Managers with study start-up, protocol development, and Trial Master File preparation.
  • Coordinate with clinical sites on documentation, training, and compliance with FDA and GCP requirements.
  • Assist with tracking study payments and providing operational support across the full study lifecycle.

The company is a partner organization specializing in clinical research and development, operating through Jobgether. It offers a structured clinical operations environment with cross-functional teams and professional growth opportunities.

Global

  • Assist in preparing clean databases by reviewing clinical trial data through CDMS or external data listings to ensure compliance with protocols.
  • Generate queries to resolve data discrepancies and support the development of CRFs and edit check specifications.
  • Maintain documentation related to CRF and data listing testing, including user acceptance testing.

Premier Research is a global clinical research, product development, and consulting company that helps biotech and specialty pharma transform life-changing ideas into new medical treatments. The company values teamwork, agility, and care for patients, providing a diverse culture with opportunities for growth and continuous learning.

$120,300–$222,600/yr
US

  • Oversee EMEA clinical trial operations, partnering with CROs and sites to ensure compliance and timely execution.
  • Lead regional regulatory submission strategies and proactively resolve operational challenges to maintain study timelines.
  • Mentor junior team members, review data and TMF documentation, and provide regular study updates to stakeholders.

Akero Therapeutics, a Novo Nordisk company, is a clinical stage biopharmaceutical company focused on developing transformative treatments for metabolic diseases. The company fosters a collaborative culture of problem solvers dedicated to bringing bold scientific approaches to patients.

US

  • Conduct clinical audits and risk assessments to identify compliance gaps.
  • Manage multiple client engagements and deliver accurate project results.
  • Build strong client relationships and present findings to leadership.

Kodiak Solutions transforms healthcare through technology-driven solutions, specializing in finance, unclaimed property, and risk management. Their innovative platform streamlines operations, allowing providers to focus on patient care.

US

  • Maintain, organize, and monitor electronic and paper medical records for completeness and regulatory compliance.
  • Process release of information requests while verifying identities, authorizations, and legal requirements.
  • Monitor compliance with HIPAA and regulatory standards, support audits, and drive quality improvements.

US Security & IT supports healthcare organizations with information management and compliance solutions. The company offers a supportive, collaborative remote environment with a focus on wellbeing and professional growth.

France

  • Oversee GCP compliance, manage deviations and CAPAs, and conduct quality and TMF reviews.
  • Maintain inspection readiness and support CRO oversight per ICH E6(R3).
  • Collaborate with Data and Clinical teams to embed compliance into workflows and train teams.

Resilience Care is a French medtech founded in 2021, offering AI remote monitoring for oncology, gastroenterology, and psychiatry. It serves 35,000 patients across 200+ facilities with an agile, collaborative culture.

Canada

  • Lead or co-lead medical writing and document quality projects, managing timelines.
  • Collaborate with cross-functional study teams to develop content strategies.
  • Review and verify documents against source materials for accuracy and compliance.

This partner company works in pharmaceutical and biotech development, creating scientifically rigorous medical content for evidence-based healthcare decisions. It emphasizes collaboration, professional development, and an inclusive culture.

US

  • Support the full grants and contracts lifecycle, from procurement and agreement development through execution, monitoring, and closeout.
  • Maintain accurate records and assist with process improvements in systems such as Smartsheet and Salesforce.
  • Provide contract-related guidance and administrative support to subcontractors, consultants, and internal stakeholders.

This organization supports global health programs by managing the operational and financial processes that move funding into implementation. It is a mission-driven, collaborative workplace focused on accountability, partnership, and meaningful impact.

US

  • Support end-to-end eQMS implementations for life sciences organizations, coordinating timelines, deliverables, and risks.
  • Participate in system configuration, data migration, validation documentation, and UAT to ensure regulatory and data integrity compliance.
  • Collaborate with Quality, IT, Validation, vendors, and client teams across all implementation phases, including go-live and post-implementation support.

The hiring partner company supports end-to-end Quality Management System implementations for life sciences clients. They offer a remote contract-to-hire opportunity with potential for long-term growth.

US

  • Lead and oversee clinical data management activities across assigned studies, ensuring high-quality data in compliance with ICH-GCP and company SOPs.
  • Manage CROs and external vendors, including database start-up, data cleaning, and database lock, while maintaining quality, timelines, and budget.
  • Collaborate cross-functionally with Biometrics, Clinical Operations, Medical, and other teams to drive data management milestones and inspection readiness.

We are developing novel biologics designed to set a new standard for the treatment of chronic skin diseases like plaque psoriasis. As a Nasdaq-listed startup, we foster a vibrant, inclusive culture where everyone is encouraged to bring their authentic selves to work.

$85,000–$110,000/yr
US

  • Process external and local lab data throughout the clinical trial lifecycle using the elluminate platform.
  • Perform QC of laboratory normal ranges, test transfers, and data listings to ensure ICH/GCP and 21 CFR Part 11 compliance.
  • Collaborate with clinical data management and cross-functional teams to support study start-up, external vendor data transfers, and data quality.

eClinical Solutions helps life sciences organizations accelerate clinical development with expert data services and the elluminate Clinical Data Cloud. The company is a people-first, inclusive organization and a 2025 Top Workplaces USA Award winner for Remote Work.

US

  • Manage integrated CMC timelines and drive alignment across technical, clinical, and regulatory teams.
  • Coordinate CDMO/CMO deliverables, budgets, and regulatory submission milestones.
  • Facilitate cross-functional meetings, track risks and action items, and provide clear program visibility.

Pulmovant is a clinical-stage biotechnology company focused on developing treatments for pulmonary diseases, with a lead candidate for pulmonary hypertension associated with interstitial lung disease. As part of the Roivant family, it fosters a collaborative and innovative culture, leveraging resources to advance its pipeline.

$155,000–$195,000/yr
North America

  • Support planning and operational execution of clinical trials, coordinating across sites, CROs, vendors, and teams.
  • Manage vendor oversight, budgets, timelines, risks, and documentation ensuring GCP compliance.
  • Serve as primary operational contact and mentor junior staff for global Phase 1-3 trials.

Jade Biosciences is a clinical-stage biotechnology company developing best-in-class therapies for autoimmune diseases. It is a small, dynamic company offering an exciting opportunity to contribute to its immunology pipeline.

US Unlimited PTO

  • Collaborate with the Clinical Operations team to support timely conduct of clinical studies according to protocols, GCP, SOPs, and regulations.
  • Lead operational management for assigned regions and sites, including vendor management and oversight of CRO monitors.
  • Contribute to the development and maintenance of study documents and ensure the Trial Master File is complete and inspection-ready.

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines for patients with genetic diseases and cancers with clear genetic drivers. Founded in 2015, the company has built a portfolio of 20+ drug development programs spanning preclinical to late-stage development across multiple therapeutic areas.

$158,000–$188,000/yr
US

  • Serve as scientific lead for clinical programs, supporting trial design, execution, data interpretation, and regulatory activities.
  • Collaborate with cross-functional teams including Clinical Operations, Biostatistics, Regulatory Affairs, and external partners.
  • Contribute to scientific publications, regulatory submissions, and relationships with investigators and key opinion leaders.

The company is a clinical-stage organization advancing innovative regenerative therapies for significant unmet needs in ophthalmology. It fosters a collaborative, high-performance culture with mentorship and professional growth opportunities.

US

  • Lead clinical data management strategy and execution across the portfolio to ensure data integrity and regulatory submission readiness.
  • Own end-to-end database lock planning and execution for pivotal trials, ensuring on-time, audit-ready locks.
  • Build and lead a fit-for-purpose data management team, including internal staff and outsourced functions, and establish SOPs and governance.

Prilenia is a private biopharmaceutical company focused on bringing transformative medicines to people with neurodegenerative diseases such as ALS and Huntington’s disease. They are a small to mid-size clinical-stage organization with a highly committed global team and a flexible, mostly remote culture.

India

  • Lead medium- to high-complexity clinical trials with full accountability for timelines, budgets, resources, and quality.
  • Oversee financial performance, risk mitigation, and quality standards while ensuring regulatory compliance.
  • Mentor Project Leaders and represent project leadership in client meetings, bid activities, and conferences.

A clinical research organization managing complex clinical trials and therapies. It fosters a fast-paced, collaborative environment focused on innovation, accountability, and professional development.

Brazil

  • Configure CTMS study and site builds to support clinical research operations.
  • Provide technical CTMS support, training, and quality control to internal users.
  • Generate operational reports and data insights to aid study readiness.

This company supports clinical research operations through reliable CTMS configuration and quality control. It fosters a collaborative, remote-friendly environment where detail-oriented analysts contribute to efficient clinical delivery.

US

  • Oversee delegated audits related to UM, Credentialing, Claims, Enrollment, and Appeals processes to ensure compliance with payer contracts.
  • Educate staff, update policies and workflows, and act as a liaison between payers and local market leadership during audits.
  • Operationalize regulatory communications from governing bodies and document process changes for upstream and downstream teams.

Dignity Health Management Services offers integrated management and business services to healthcare providers, focusing on managed care administrative and clinical services to contain costs and improve quality. It is part of CommonSpirit Health, a large health system with a mission-driven culture centered on community and patient care.