Senior Clinical Data Manager
$85,000–$120,000 year
HybridDurham, North Carolina, United States
Job Summary
Lead studies including healthy volunteer and patient populations, multi-site, and complex protocol designs while managing reduced timelines. Act as the Study Manager accountable for all DM deliverables, instructing the study team and reviewing output to ensure quality and adjust resource allocations. Ensure projects follow strict protocols, global harmonized SOPs, and GCPs. Build timelines with Project Managers to meet contracted milestones by coordinating with leads in EDC Design, SAS Programming, Statistics, and PK. Provide DM project team leadership, leading internal meetings and proactively identifying risks to achieve database lock dates. Maintain awareness of Biometrics functional group deliverables to support risk strategies. Coordinate data receipt from clinical sites and vendors, ensuring documentation is performed upon project completion. Develop and maintain client relationships, review satisfaction surveys, and drive process improvements and team training. Track scope changes, secure Sponsor approval, and process changes. Provide leadership, mentorship, and coaching to the internal study team on clinical trial processes and technical capabilities. Learn new DM technologies and applied processes to improve operations. Ensure service and quality meet specifications per the DMP and scope of work. Write, review, and update SOPs and associated documents. Maintain accurate records of all work undertaken. Reconcile the clinical database against safety, laboratory, or third-party data using local systems and batch load facilities. Represent DM and Biometrics in new business opportunities. Attend and action client or internal audits, resolving issues within an appropriate timeframe. Work with management to develop directional strategy, providing technical input into discussions and rolling out training. Promote Biometrics services to sponsors whenever possible. Perform other related duties as assigned by management.
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
- Thorough knowledge of DM
- Thorough knowledge of clinical operations
- Thorough knowledge of biometrics
- Thorough knowledge of system applications to support operations
- Proven ability to lead by example on project strategies
- Proven ability to achieve department goals, objectives, and initiatives
- Ability to encourage team members to seek solutions
- Working knowledge of the relationship and regulatory obligation of the CRO industry
- Working knowledge of pharmaceutical/biotechnological companies
- Time management skill
- Ability to adhere to project productivity metrics and timelines
- Ability to work in a team environment
- Ability to collaborate with peers
- Ability to mentor junior members of the department
- SME guidance on DM practices
- Experience of representing DM in bid defense meetings
- providing innovative solutions to meet client needs
- Good organizational ability
- communication skills
- interpersonal skills
- Constructive problem-solving attitude
- deadline focused
- time demands
- incomplete information
- unexpected events
- Potential travel for cross-site support or training needs
- meetings up to 10% of the time
- up to 50% of that time requiring an overnight stay
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
- Standard Operating Procedures (SOPs)
- Four or more years of Electronic Data Capture experience
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