Sr. Clinical Trial Coordinator (CTC)

Convatec • Lexington, MA

16h • Remote

About The Position

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com
Convatec is looking for a senior electronic Trial Master File (eTMF) specialist who will be responsible for the oversight, operational management, and continuous improvement of the Trial Master File across clinical studies. This role ensures that TMF processes, systems, and documentation comply with global regulatory requirements (e.g., ICH-GCP, FDA, EMA) and support inspection readiness at all times.

Position Overview:
The Sr. Clinical Trial Coordinator (CTC) plays a key role to the success of Convatec’s clinical trials. The Sr. CTC’s primary role is to ensure the accurate and complete organization of the eTMF for Convatec clinical trials, maintaining adherence to Good Clinical Practice (GCP) guidelines and relevant regulations. The Sr. CTC will manage document processing, quality control, and system administration to ensure the eTMF for all Convatec clinical trials is compliant and ready for regulatory inspections and audits.

Requirements

• Strong understanding of clinical trials and eTMF systems.
• Proficiency in using eTMF platforms (e.g., Veeva, CTMS).
• Excellent organizational and time management skills.
• Attention to detail and ability to maintain consistency in document processing.
• Strong communication and interpersonal skills to collaborate with study teams.
• Knowledge of GCP guidelines and regulatory requirements.
• Ability to work independently and as part of a team.
• Bachelor’s degree in a scientific or healthcare-related field is preferred (years of experience may be considered in lieu of a bachelor’s degree)
• 2 years of experience as a CTC or a similar role in the medical device or clinical research industry
• Strong understanding of clinical trial processes and regulatory guidelines.
• Excellent attention to detail with problem-solving and analytical skills.
• Strong organizational and time management abilities.

Nice To Haves

• Proficiency in electronic Trial Master File systems (experience with Veeva is a plus).

Responsibilities

• Uploading, reviewing, indexing, and archiving documents within the eTMF system (Veeva)
• Performing quality checks on documents to ensure accuracy, completeness, and compliance with SOPs, WIs, and regulations
• Liaising with study teams, sites, and CROs to facilitate document exchange and ensure efficient eTMF management
• Maintain study-specific documentation and provide global support with study team lists, project-specific training requirements, and assist CSMs / CRAs in collecting study specific records from investigative sites participating in Convatec clinical trial(s) as required
• Analyzing document quality, and identifying areas for improvement
• Conduct department and investigator file reviews as assigned, documenting findings in the appropriate systems
• Work closely with CRAs during monitoring visits to provide missing documents required for the eTMF, are available for site audits, and address any findings promptly
• Proactively communicate any findings / issues to management
• Ensuring the eTMF is compliant with GCP, regulatory guidelines, and company SOPs
• Generate metrics for department and study team usage supporting TMF completeness, accuracy and quality
• Preparing the eTMF for audits and inspections, and participating in audit activities
• Attend kickoff meetings / study core team meetings and take notes as required

Benefits

• This role is eligible for performance-based incentive compensation.
• We also offer a comprehensive benefits package, which includes a retirement savings plan with company match, time off to include: paid vacation, holidays, community service days, sick time, paid caregiver/parental leave and medical leave, and health benefits for individuals, families, and domestic partners, including medical, prescription drug, dental, and vision coverage, in accordance with the terms of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level