Senior Clinical Data Manager

Convatec • Lexington, MA

3d • 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
Position Overview:
The Senior Clinical Data Manager (Sr. CDM) is responsible for overseeing end-to-end data management for Convatec’s clinical trials, ensuring data integrity, accuracy, and compliance with GCP and regulatory standards. They lead study start-up, eCRF design, edit check development, and database lock while mentoring junior staff.

Requirements

• Working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, understanding and experience with up-to-date MS Windows Operating Systems and applications and at least one Database Management/EDC System (e.g., Veeva Vault, Medidata Rave, etc.)
• Experience operating as primary contact for Data Management activities
• Possess an understanding of database structure and processes in data management; and basic knowledge of medical terminology is needed, as well as knowledge of clinical research methodologies.
• Knowledge of ICH / GCP regulations, CDISC and SDTM standards.
• Excellent attention to detail with problem-solving and analytical skills.
• Strong organisational and time management abilities.
• Bachelor’s degree or equivalent professional certification
• 5-8+ years experience in a clinical data management or similar role in the medical device or clinical research industry.

Responsibilities

• Act as the main point of contact for all assigned Data Management activities from study start up to database lock as well as all related data management tasks in the electronic data capture system (Veeva Vault CDMS).
• Participate in protocol development activities for key areas for Data Management.
• Review draft protocols and eCRFs for potential data collection and representation, database structure or database entry problems, review data listings and database to ensure all captured data follow the rules outlined by the protocol and DMP.
• Lead EDC system design, CRF design, user acceptance testing (UAT), and edit check programming.
• Prepare Data Management Plans (DMP), CRF completion guidelines, Data Management reports and other documents required for the preparation and completion of databases.
• Performs and oversees data review to identify discrepancies, ensuring accuracy and consistency.
• Prepare routine reports to ensure appropriate study oversight, such as missing data reports, subject status report, open query reports, etc.
• Be responsible for training clinical study staff, both internal and external on the use of the electronic data capture system.
• Support in the development of local processes/SOPs to improve Data Management.
• Collaborate with cross functional clinical team for ongoing study activities.
• Work in conjunction with the assigned Statistician to ensure reliable datasets containing high quality data are provided for analysis.
• Ensures all data activities adhere to ICH-GCP, FDA/ICH guidelines, and SOPs.
• Mentors junior staff, manages timelines, and drives process improvements.
• Any other duties relevant to this post which may arise and as requested.

Benefits

• retirement savings plan with company match
• paid vacation
• holidays
• community service days
• sick time
• paid caregiver/parental leave and medical leave
• health benefits for individuals, families, and domestic partners, including medical, prescription drug, dental, and vision coverage

What This Job Offers

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