Talent.com
Alimentiv
TMF CoordinatorAlimentiv • Ottawa, Ontario, Canada, K0A 3H0
TMF Coordinator

TMF Coordinator

Alimentiv • Ottawa, Ontario, Canada, K0A 3H0
1 day ago
Salary
CA$42,000.00–CA$70,000.00 yearly
Job type
  • Full-time
Job description


TMF Coordinator

We are seeking a detail-oriented and highly organized TMF Coordinator to join our TMF Operations team. In this role, you will be responsible for maintaining the quality, completeness, and compliance of Trial Master File (TMF) documentation in alignment with global regulatory requirements and company standards. You will play a key role in ensuring that TMF content remains inspection-ready and supports clinical trial execution through effective document management and collaboration with cross-functional stakeholders.

Positions Available: 2; Note this position is cross-listed in multiple countries.

TMF Oversight & Compliance

  • Maintain in-depth knowledge of TMF structures (paper and electronic)
  • Ensure compliance with ICH-GCP, FDA, and EMA regulations
  • Apply ALCOA+ data integrity principles
  • Support inspection readiness and audit activities
  • Ensure proper management of essential clinical trial documentation

Systems & Document Management

  • Accurately file, classify, and index documents within the TMF
  • Ensure adherence to version control and naming conventions
  • Utilize eTMF systems (e.g., Veeva Vault, Phlexglobal, Trial Interactive)
  • Maintain consistency and compliance of TMF structure
  • Demonstrate proficiency in eTMF and document management systems
  • Utilize Microsoft Office tools (Excel, Word, SharePoint) for reporting and coordination

Quality Control

  • Perform QC checks on TMF documents and metadata
  • Identify and resolve missing, incomplete, or inconsistent records
  • Ensure overall accuracy, completeness, and timeliness of TMF content
  • Support TMF health checks and reporting metrics

Issue Resolution & Continuous Improvement

  • Investigate and resolve TMF gaps and discrepancies
  • Troubleshoot filing and system-related issues
  • Contribute to process improvements and standardization initiatives
  • Support root cause analysis for quality issues

Stakeholder Engagement

  • Collaborate with study teams and Proactively follow up on outstanding documentation
  • Provide clear guidance on TMF requirements and processes
  • Support audit and inspection readiness activities

Required Qualifications & Experience

  • Bachelor’s degree in Life Sciences or a related field (preferred)
  • 1-3 years experience in clinical trials TMF management
  • Working knowledge of eTMF platforms and regulatory requirements
  • Strong understanding of clinical trial record management and quality standards
  • Working remotely

Core Competencies

  • Strong attention to detail and quality focus
  • Excellent organizational and time management skills
  • Effective communication and stakeholder engagement
  • Analytical thinking and problem-solving ability
  • Ability to manage multiple priorities in a fast-paced environment

+ bonus


$42,000 - $70,000 a year

Compensation details: 42000-70000 Yearly Salary





PIbd5e758c2df2-30511-41544243

Create a job alert for this search

TMF Coordinator • Ottawa, Ontario, Canada, K0A 3H0

Similar jobs

Bilingual Financial Advisor

Opal Corporate ConnectionsEmbrun, ON, CA
Full-time

Conseiller les clients sur les meilleures stratégies et déterminer avec eux les résultats visés.Responsable de la relation d’affaires, évaluer la satisfaction des membres et clients et la qualité d... Show more

 • Promoted

Compassionate Massage Therapist – Join Our Team

Lifemark Health GroupRockland, Ontario, Canada
Full-time

Make a meaningful impact as a Massage Therapist dedicated to enhancing client well-being.Collaborate within a supportive environment to provide top-quality care and education.We are seeking a drive... Show more

 • Promoted

Exciting Associate Veterinarian Role in Ontario

VetStrategyEmbrun, Ontario, Canada
Full-time

Explore the opportunity to become an Associate Veterinarian with VetStrategy at the Embrun Veterinary Hospital.We're dedicated to providing excellent care in a collaborative and growth-oriented env... Show more

 • Promoted

Human Rights Policy Advisor - Renewable Energy - Spanish Required

Cuso InternationalClarence-Rockland, Ontario
Permanent

This Volunteer Placement is Located in:.Tegucigalpa, Francisco Morazán Department, Honduras.Private Spanish lessons can be arranged if necessary.Please submit a Spanish Resume and Statement of Inte... Show more

 • Promoted

Office Manager

Sienna Senior LivingClarence-Rockland, Prescott and Russell Counties, CA
Full-time

Aspira Rockland Manor Retirement Living.This posting is for an new vacancy.At Sienna Senior Living, our commitment to enhancing the daily lives of our residents extends far beyond clinical care.Int... Show more

 • Promoted

Advanced Manufacturing Technician at Authentix

AuthentixThurso, QC, CA
Full-time

Step into an impactful role as a Production Technician at Authentix in Thurso, Quebec, where your skills will directly support leading-edge manufacturing solutions.Troubleshoot and optimize advance... Show more

 • Promoted

Registered Massage Therapist

Lifemark Health GroupRockland, ON, CA
Full-time

Are you a passionate Massage Therapist dedicated to enhancing the health and well-being of Canadians? At Lifemark, your work makes a real difference—expanding access to care and creating lasting im... Show more

 • Promoted

Front Desk Agent Part Time - $15.00

Kingsmill ResortWilliamsburg, ON, CA
Part-time

To establish and provide excellent guest service, registering and greeting guests at point of check-in and throughout their stay, while processing payments and posting charges to guest accounts.Mai... Show more

 • Promoted

Personal Support Worker

Saint ElizabethEmbrun, ON, CA
Part-time

We are currently hiring Part Time Day and/or Evening Personal Support Workers (PSW) for Community Care and surrounding areas.Drive Your Career Forward with Us – We'll Cover Your Mileage and Travel ... Show more

 • Promoted

Membre du Comité conjoint de vérification de conformité

The Nation MunicipalityRussell, ON, CA
Full-time

Membre du Comité conjoint de vérification de conformité.Les municipalités situées dans les Comtés unis de Prescott et Russell recrutent des professionnels expérimentés afin de les nommer à leur Com... Show more

 • Promoted

Associate Veterinarian- Embrun Veterinaryl Hospital

VetStrategyEmbrun, ON, CA
Full-time

Across Canada, VetStrategy is a network of veterinary practices united by a shared purpose: healthy animals, happy owners.We Bring This To Life Through Three Promises.Our People Promise – To be a g... Show more

 • Promoted

Patient Coordinator - Bright Dental Centre, Russell, ON

123DentistRussell, ON, CA
Part-time

Patient Coordinator - Bright Dental Centre, Russell, ON.Part Time Reception - Clinic ON-101 Bright Dental, Russell, ON, CA.At Bright Dental Centre, we’re more than just a dental office—we’re a fami... Show more

 • Promoted

CRM and Data Management Advisor - Spanish Required

Cuso InternationalClarence-Rockland, Ontario
Permanent

This Volunteer Placement is Located in:.Please submit a Spanish Resume and Statement of Interest.Open to Canadian Citizens and Permanent Residents of Canada only.This placement is an opportunity to... Show more

 • Promoted

Assistant Director of Wellness

Sienna Senior LivingClarence-Rockland, Prescott and Russell Counties, CA
Full-time +1

Assistant Director of Wellness- Permanent Full Time.Aspira Rockland Manor Retirement Living.This posting is for an existing vacancy.At Sienna you won’t just fill a position; you will build lasting ... Show more

 • Promoted

Senior Accountant

Baker TillyMorrisburg, ON, CA
Full-time +1

Assist in the planning, execution, and completion of a wide range of Audit, Review and Compilation engagements, both independently and as part of a team.Analyze financial information, accounting pr... Show more

 • Promoted

Occupational Therapist

Spark LifecareRussell, ON, Canada
CA$69.83–CA$122.50 hourly
Full-time
Quick Apply

Apply here to complete a short video-based interview & upload your resume: https://www.At Spark, we're on a mission to make a difference in the way community healthcare is done.As a leading hea... Show more