Senior Clinical Data Manager (Remote US or Canada)
$80,000–$145,000 year
RemoteUnited States or Canada
Job Summary
Lead studies including healthy volunteer and patient populations, multi-site, and complex protocol designs while managing reduced timelines. Act as subject matter expert for data management activities from study start-up to database lock, ensuring strict adherence to protocols, global harmonized SOPs, and GCP standards. Provide leadership and mentorship to junior staff, review study team outputs, and adjust resource allocations to meet contracted milestones. Coordinate with project managers, EDC design, SAS programming, statistics, and PK leads to plan deliverables and identify risks. Manage client relationships, review satisfaction surveys, and implement process improvements. Represent data management in new business opportunities and bid defenses. Maintain accurate records, perform database reconciliations, and attend client or internal audits.
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
- Minimum of 1-year Veeva EDC experience
- 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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