Manager, Centralized Data & Sample Management – UK, Poland or South Africa

Role Overview

• Lead the planning and oversight of clinical samples and external data sources for assigned studies, ensuring effective management of related procedures and deliverables, including: 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.
• Able to travel to off-site meetings or training seminars as needed.

Benefits

• Participation in Parexel’s annual performance-based bonus plan
• Annual salary review
• Total rewards incentives