Clinical Scientist interpreting WES/WGS data and classifying variants for SeqOne, a clinical genomics company. Supporting rare - disease diagnostics through regulated, patient - centered genomic reporting.
About the role
- Senior Clinical Data Manager leading oncology clinical trials at Fortrea, a global clinical research organization. Owning data management from study start-up through database lock.
Responsibilities
- Lead clinical data management studies involving healthy volunteer and patient populations, multi-site studies, complex protocols, client management, or reduced timelines
- Own data management deliverables from study start-up through database lock
- Develop project documentation, system setup, data entry, and data validation procedures
- Build timelines with Project Managers or FSP Leads to meet contracted milestones
- Lead data-focused internal project team meetings and coordinate deliverables across EDC Design, SAS Programming, Statistics, and PK
- Identify risks and mitigations and communicate data-driven discussions to achieve database lock dates
- Coordinate receipt and inventory of data from clinical sites and vendors
- Ensure projects follow protocols, global harmonized SOPs, GCP standards, DMPs, and scope of work
- Maintain client relationships, review satisfaction surveys, and implement action plans and process improvements
- Track scope changes and secure Sponsor approval
- Provide leadership, mentorship, coaching, training, and performance feedback to data management staff
- Reconcile clinical databases against safety, laboratory, and third-party data
- Utilize local laboratory systems and batch data load facilities
- Support new business opportunities, bid defense meetings, audits, and sponsor-facing Biometrics activities
- Contribute to SOP development and maintain accurate work records
- Keep stakeholders informed about project progress, budgets, scope changes, and timeline impacts
Requirements
- University / college degree; relevant work experience equating to a bachelor's degree accepted in lieu
- Relevant and equivalent experience may be accepted in lieu of educational requirements
- English required for speaking, writing, and reading
- 8 years of combined early or late-stage DM experience
- Minimum 2 years of direct sponsor management experience
- At least 2 years of technical mentoring experience
- 3–5 years of Oncology experience
- Experience handling customer negotiations and managing Scope of Work and budgets
- Thorough knowledge of clinical trial processes, data management, clinical operations, biometrics, and supporting system applications
- Working knowledge of CRO regulatory obligations and relationships with pharmaceutical/biotechnology companies
- Ability to adhere to project productivity metrics and timelines
- Ability to mentor junior department members and provide SME guidance on data management practices
- Experience representing data management in bid defense meetings
- Four or more years of Electronic Data Capture experience preferred
- University / college degree in life sciences, health sciences, information technology, or related subjects preferred
- Knowledge of Fortrea’s organization and SOPs preferred
Benefits
- Potential travel for cross-site support or training needs, meetings up to 10% of the time, with up to 50% of that time requiring an overnight stay
- Compensation considers skills, prior relevant experience, applicable degrees/certifications, internal equity, and market data
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