Talent.com
Alimentiv
TMF CoordinatorAlimentiv • Kitchener, Ontario, Canada, N2R 1V2
TMF Coordinator

TMF Coordinator

Alimentiv • Kitchener, Ontario, Canada, N2R 1V2
10 hours 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





PI147eb673b6c7-30511-41544244

Create a job alert for this search

TMF Coordinator • Kitchener, Ontario, Canada, N2R 1V2

Similar jobs

Logistics Coordinator: Oversize & Project Cargo

THOMAS FreightCambridge, Region of Waterloo, CA
Full-time

A logistics company in Cambridge, ON is seeking a Domestic Logistics Coordinator to manage and coordinate freight shipments.Responsibilities include monitoring cargo, liaising with shippers, and en... Show more

 • Promoted

Remote Technical Solutions Coordinator (BESS)

CsestorageKitchener, Region of Waterloo, CA
Remote
Full-time

A renewable energy company is seeking a Technical Solutions Coordinator to support product development and drive operational excellence.This hybrid role involves maintaining product trackers, manag... Show more

 • Promoted

Care Coordinator for Integrated Health Services

Ontario Health atHomeGuelph, ON, CA
Full-time

Be a vital part of Ontario Health atHome as a Care Coordinator, where you will assess patient needs and facilitate access to essential community services.Join a collaborative environment focused on... Show more

 • Promoted

Logistics Coordinator at Aecon in Cambridge

Aecon Group Inc.Cambridge, Region of Waterloo, CA
Full-time

Enhance your career with Aecon as a Logistics Coordinator located in Cambridge, Ontario.This role is essential for coordinating material logistics for the ambitious Darlington New Nuclear Project.Y... Show more

 • Promoted

Materials Coordinator

Arrow Machine And Fabrication GroupCambridge, Region of Waterloo, CA
Full-time

Group is an engineering-focused solution provider of machined castings, fabrications, and assemblies.We serve OEM customers in the rail, material handling, mining, defense, heavy truck, agriculture... Show more

 • Promoted

Quality Coordinator (BESS) - 4 Month Term

Valard ConstructionGuelph, ON, CA
Permanent

Our Substation and Renewables group is currently looking to add a Quality Coordinator to our growing team on a 4-month term (April - July 2026 with an opportunity to extend), based in Southwestern ... Show more

 • Promoted

Field-Based Addiction & Mental Health Support Coordinator

Uniting HoldingGuelph, ON, CA
Full-time

A healthcare organization is seeking an Addiction Support Coordinator to improve the quality of clients' lives by delivering vital clinical and support services.Responsibilities include managing cl... Show more

 • Promoted

Expert Materials Procurement Coordinator

Arrow Machine And Fabrication GroupCambridge, Region of Waterloo, CA
Full-time

Streamline materials procurement as a dedicated Materials Coordinator, focusing on effective scheduling, inventory management, and timely material distribution to meet production needs.In this role... Show more

 • Promoted

Flight Coordinator (Dispatch)

FlightpathCambridge, Region of Waterloo, CA
Full-time

Join Flightpath Charter Airways – Where Excellence in Hospitality Takes Flight.At Flightpath Charter Airways, we don’t just fly—we create exceptional experiences.Our team is dedicated to delivering... Show more

 • Promoted

Project Support Coordinator

Insight GlobalCambridge, Region of Waterloo, CA
Temporary

Insight Global is looking for a.This candidate is responsible to provide leadership and strategic scheduling, cost management, and cost/schedule integration in support of managing projects from pro... Show more

 • Promoted

Kitchener TFC Competitive Programs Coordinator

Kitchener SC and Kitchener TFCKitchener, Region of Waterloo, CA
Full-time

The Competitive Programs Coordinator will be the administrative/operational lead for the Club’s competitive programs, while supporting program growth and providing excellent customer service to the... Show more

 • Promoted

Remote Technical Solutions Coordinator (BESS)

e-STORAGEKitchener, Region of Waterloo, CA
Remote
Full-time

A renewable energy solutions provider is seeking a Technical Solutions Coordinator to support product development within the BESS Solutions team.This remote position will drive operational excellen... Show more

 • Promoted

Service Coordinator/Scheduler

Liftsafe Group of CompaniesCambridge, Region of Waterloo, Canada
Full-time

Liftsafe Group of Companies is a privately owned company that designs, builds, inspects and maintains lifting, material handling, and fall protection systems equipment.Liftsafe Group of Companies i... Show more

 • Promoted

Audit Partner - Technology, Media & Telecom - TMT

RSM CanadaKitchener, Region of Waterloo, CA
Full-time

RSM Canada is seeking an experienced Audit Partner to join the Technology, Media & Telecommunications (TMT) practice.Our TMT team serves public and private clients, including growth‑oriented, priva... Show more

 • Promoted

Client Care Coordinator

Brobston Group LLCCambridge, Region of Waterloo, CA
Full-time

The Client Care Coordinator manages aftercare and workshop operations to ensure a seamless client journey for repair and service requests.This temporary role coordinates logistics between workshops... Show more

 • Promoted

Senior Support Coordinator

Homewood Health CentreGuelph, ON, CA
Full-time +1

Senior Support Coordinator – Homewood Health Centre.Make a difference in a growing, innovative mental health organization and centre of excellence in people‑centered care.Provide support coordinati... Show more

 • Promoted

Customer Service Coordinator

RLB LLPGuelph, ON, CA
Full-time

Ontario Pork, based in Guelph, is seeking a Customer Service Coordinator to join our dynamic team.Reporting to the Director of Sales, the successful candidate will play a key role in supporting our... Show more

 • Promoted

Maintenance Coordinator

FUCHS LUBRICANTS CO.Cambridge, Region of Waterloo, CA
Full-time

FUCHS offers a challenging and rewarding working environment where employees are encouraged to develop and grow.FUCHS offers competitive pay commensurate with experience.The range for this position... Show more

 • Promoted

Management Trainee

Enterprise HoldingsGuelph, ON, CA
Permanent

Start your career with Enterprise Mobility! We’re.Whether you see yourself in sales, business development, customer service, retail management, or operations, as a manager in training, you can coun... Show more

 • Promoted

NIGHT COORDINATOR

Community Living CambridgeCambridge, Region of Waterloo, CA
Full-time

Notice: SORRY WE ARE NO LONGER TAKING APPLICATIONS FOR THIS POSITION.This Job posting is only for Internal Community Living Cambridge Staff member.TYPICAL HOURS OF WORK: 40 hrs weekly.Bi-Weekly Fle... Show more