Senior Clinical Data Manager – Medical Devices

About the role

Fortrea is seeking a Senior Clinical Data Manager to lead data management activities for medical device studies. You will own the full data lifecycle—from study start‑up through database lock—ensuring high‑quality deliverables that meet sponsor expectations and regulatory standards.

Key responsibilities

• Lead and coordinate all data management (DM) deliverables, supervising junior staff and allocating resources as needed.
• Develop project documentation, set up EDC systems, and define data entry and validation procedures.
• Collaborate with sponsors to capture requirements and act as the subject‑matter expert for DM activities.
• Work with project managers to build timelines, monitor progress, and communicate risks and mitigations.
• Facilitate cross‑functional meetings with EDC design, SAS programming, and statistics teams to align deliverables and achieve database lock dates.
• Maintain compliance with protocols, GCP, SOPs, and global standards.
• Oversee data receipt, inventory, and documentation from clinical sites and vendors.
• Develop and nurture client relationships, reviewing satisfaction surveys and implementing improvement actions.

Required profile

• Extensive experience in clinical data management for medical device trials.
• Proven leadership skills with the ability to mentor and guide junior staff.
• Strong client‑facing abilities and excellent communication skills.
• Ability to prioritize workload, manage multiple projects, and meet tight deadlines.

Required skills

• Electronic Data Capture (EDC) systems
• SAS programming
• Statistical analysis concepts
• Good Clinical Practice (GCP) knowledge