Clinical Data Manager (Sponsor-Dedicated)

About the role

Fortrea is looking for a Clinical Data Manager who leads data management on studies and takes responsibility for developing project documentation, system set-up, data entry and data validation procedures and processes for more junior staff. The role covers all DM activities from study start-up to database lock, within project timelines and budgets, and works directly with Sponsors to implement their requirements.

Key responsibilities

• Lead studies, including healthy volunteer and patient populations and multi-site studies, and manage client requirements or reduced timelines.
• Be accountable for all DM deliverables, instruct the DM study team, review their output and adjust resource allocation.
• Ensure projects follow protocols, global harmonized SOPs and GCP standards.
• Build timelines with Project Managers to meet contracted milestones, attend study initiation meetings and coordinate with EDC Design, SAS Programming, Statistics and PK leads.
• Lead data-focused internal meetings, identify risks and mitigations and communicate progress to the Project Manager, Biometrics management team and sponsor services.
• Track scope changes, obtain Sponsor approval and process them, and keep clients informed of budget, scope and timeline impacts.
• Mentor and coach the internal study team, support performance evaluations and give constructive feedback.
• Learn new DM technologies, keep records of work, reconcile the clinical database against safety, laboratory or third-party data, and attend and act on audits.
• Promote Biometrics services to sponsors and represent the function in new business opportunities.

Required profile

• University or college degree; equivalent experience may be considered in its place.
• 6 to 8 years of DM experience, including at least 1 year of direct sponsor management.
• Fluent English, written and spoken.
• Preferred: experience handling customer concerns and managing Scope of Work and budgets.

Required skills

• Knowledge of clinical trials, data management, clinical operations, biometrics and system applications.
• Time management and adherence to project timelines.
• Team collaboration, organization and communication skills.
• Knowledge of medical terminology.
• Preferred: 3+ years of Electronic Data Capture experience, a life sciences or IT degree, and thorough knowledge of Fortrea's SOPs.