Manager, Centralized Data & Sample Management – FSP
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Job Description
Manager, Centralized Data and Sample Management overseeing data transfers for studies at Parexel. Contributing to growth of Clinical Data Operations Team while working remotely from Poland, South Africa, or the UK.
Responsibilities:
- Lead the planning and oversight of clinical samples and external data sources for assigned studies, ensuring effective management of related procedures and deliverables
- Understand trial-specific requirements for external data sources and logistics; advise on provider contracting
- Develop Sample Management Plan and data transfer agreements; coordinate with third-party vendors on study documentation
- Review and provide feedback on study documents (e.g., Clinical Monitoring Plans, informed consent forms)
- Support vendor system setup (e.g., labs, imaging)
- Ensure study team are informed of data flows and reconciliation requirements
- Perform reconciliation between EDC and external data sources; provide sample shipping manifests where applicable
- Proactively identify transfer/data issues, plus trends and provide proposals to remedy the in scope third party data/deliverables
- Identify and resolve data transfer issues; monitor trends and recommend corrective actions
- Assess risks to timelines for data deliverables; develop mitigation strategies and recommendations
- Provide input into vendor budgets and change orders; support invoicing as needed
- Maintain proactive communication with study team and external vendors regarding deliverables and status
- Maintain study documentation in the eTMF
- Coordinate closely with Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Drug Safety, Project Management and Regulatory to ensure operational excellence on assigned product/program
- Participate in regular Clinical Data Operations team meetings and provide input when appropriate
- Contribute to or lead department process improvement initiatives which could include the development of data management SOPs, Work Instructions, and process documents
- Onboard and/or train new employees and/or contractors
- Maintain current professional knowledge of regulatory requirements and industry best practices in relevant areas of CDM, Third Party Vendors and related data sources/deliverables, technology advances and quality assurance
Requirements:
- Bachelor’s degree required, scientific/healthcare preferred
- At least five years of experience in Clinical Data Management and/or sample management/third party data sources and/or Clinical Operations for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment, including study lead experience
- Knowledge of Third-Party data/deliverables sources, including laboratory sample management
- Demonstrate a comprehensive understanding of regulatory guidelines and industry standards related to Third Party data/deliverables
- Has good project management skills and a proven ability to prioritize across multiple tasks
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
- Experience working with a globally distributed team
- Good communication/interaction skills and experience in a dynamic and growing organization
- Experience of Risk Based Monitoring principles and using critical thinking to assess and manage risk on assigned studies
- Effective leadership skills and proven ability to foster team productivity and cohesiveness.
- Possesses strong English language written and verbal communication skills.
- Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications.
- Prior experience with different Data Management/Clinical Study systems and technologies, and Electronic Data Capture systems is desirable.
Benefits:
- In addition to base salary, some roles may be eligible for participation in Parexel’s annual performance-based bonus plan
- annual salary review and total rewards incentives
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