Senior Clinical Data Manager

We are seeking an experienced Senior Clinical Data Manager to lead data management activities for clinical trials. As a Senior Clinical Data Manager, you will be responsible for providing leadership and oversight for data management activities from study start-up to database lock. You will work closely with clients, project managers, and internal stakeholders to ensure high-quality deliverables and optimal processes.

Key Responsibilities:

• Lead studies with complex protocol designs, multi-site, and reduced timelines, ensuring high-quality deliverables and effective prioritization of workload
• Provide instruction and guidance to junior data management staff and review their output to ensure quality and timeliness
• Develop and maintain client relationships, review client satisfaction surveys, and implement process improvements and team training as needed
• Ensure compliance with global harmonized SOPs, GCPs, and client-specific requirements
• Collaborate with cross-functional teams, including EDC Design, SAS Programming, Statistics, and PK to ensure integrated project planning and execution
• Identify potential risks and mitigations, communicate data-driven discussions, and ensure database lock dates are met
• Maintain awareness of Biometrics functional group deliverables and support risk and mitigation strategies
• Represent data management in new business opportunities, bid defense meetings, and client interactions

Requirements:

• University/college degree in a life science, health science, or related field
• 8 years of combined early or late-stage data management experience, with at least 2 years of direct sponsor management and 2 years of technical mentoring experience
• Thorough knowledge of clinical trial processes, data management, clinical operations, biometrics, and system applications
• Proven ability to lead by example, manage projects, and mentor junior team members
• Excellent communication, interpersonal, and problem-solving skills
• Ability to work in a team environment and collaborate with peers

Preferred Qualifications:

• Experience with Electronic Data Capture systems
• Knowledge of Fortrea's organisation and Standard Operating Procedures (SOPs)
• Life sciences, health sciences, information technology, or related subject degree

Physical Demands/Work Environment:

• Office or remote-based work with potential travel up to 10% of the time, including overnight stays