Senior Clinical Data Manager (External Data)
Remote
Job Summary
Develop Vendor Data Plans, obtain final approvals, and ensure electronic external vendor data transfers meet protocol specifications and populate specified fields correctly. Lead studies involving healthy volunteers, patients, and multi-site complex designs while organizing workload to deliverables on strict timelines. Provide study team leadership, mentor junior staff, and review outputs to ensure highest quality adherence to GCPs, SOPs, and global harmonized standards. Coordinate data receipt from clinical sites and vendors, manage scope changes with sponsor approval, and proactively identify risks to achieve database lock dates. Represent DM and Biometrics in new business opportunities, attend audits, and implement process improvements based on client feedback.
Required Qualifications
- University / college degree
- Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor's degree
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements
- Speaking/Writing/Reading: English required
- 8 years of combined early or late-stage DM experience
- minimum 2 years of direct sponsor management
- at least 2 years technical mentoring experience
- Proven experience in handling customer negotiations
- experience with managing Scope of Work and budgets
- Thorough knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations
- Proven ability to lead by example on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions
- Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies
- Time management skill and ability to adhere to project productivity metrics and timelines
- Ability to work in a team environment and collaborate with peers
- Ability to mentor junior members of the department, providing SME guidance on DM practices
- Experience of representing DM in bid defense meetings, providing innovative solutions to meet client needs
- Good organizational ability, communication, and interpersonal skills
- Constructive problem-solving attitude while deadline focused with time demands, incomplete information or unexpected events
Desired Qualifications
- University / college degree (life sciences, health sciences, information technology or related subjects preferred)
- Through knowledge of Fortrea, the overall structure of the organization and Standard Operating Procedures (SOPs)
- Four or more years of Electronic Data Capture experience
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