Convatec · 1 day ago
Sr. Clinical Trial Coordinator (CTC)
United States
Full-time
Remote
Mid, Senior Level
2+ years expConvatec is a global medical products and technologies company focused on solutions for the management of chronic conditions. The Sr. Clinical Trial Coordinator will oversee the operational management and compliance of the Trial Master File for clinical studies, ensuring adherence to regulatory requirements and quality standards.
Clinical TrialsHealth CareManufacturingMedical
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
Qualification
Required
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
Proficiency in electronic Trial Master File systems (experience with Veeva is a plus)
Excellent attention to detail with problem-solving and analytical skills
Strong organizational and time management abilities
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
Company
Convatec
ConvaTec specializes in the development, manufacture, distribution of single-use devices to hospitals and healthcare sectors. It is a sub-organization of The Amcare™ Group.
5001-10000 employees
H1B Sponsorship
Convatec 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)
2021 (1)
2020 (6)
Funding
Current Stage
Public CompanyTotal Funding
$1.72BKey Investors
Novo Holdings
2025-11-18Post Ipo Secondary· $461.47M
2017-03-29Post Ipo Secondary· $1.26B
2016-10-27IPO
Leadership Team
Karim Bitar
Chief Executive Officer
David Shepherd
President & COO- Advanced Woundcare
Recent News
DelveInsight Business Research LLP
2025-11-20
Company data provided by crunchbase