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

📋 Description

• Oversee the planning and management of clinical samples and external data sources for designated studies, ensuring the effective administration of related procedures and deliverables, including understanding trial-specific requirements for external data sources and logistics; advising on provider contracting.

• Create Sample Management Plans and data transfer agreements; collaborate with third-party vendors on study documentation.

• Evaluate and provide feedback on study documents (such as Clinical Monitoring Plans and informed consent forms).

• Assist in the setup of vendor systems (e.g., labs, imaging).

• Ensure the study team is well-informed about data flows and reconciliation requirements.

• Conduct reconciliation between EDC and external data sources; supply sample shipping manifests when applicable.

• Proactively identify data transfer issues, trends, and propose solutions for on-scope third-party data/deliverables.

• Detect and resolve data transfer challenges; monitor trends and suggest corrective actions.

• Evaluate risks to timelines for data deliverables; devise mitigation strategies and recommendations.

• Contribute to vendor budgets and change orders; assist with invoicing as necessary.

• Maintain proactive communication with the study team and external vendors regarding deliverables and status updates.

• Keep study documentation up to date in the eTMF.

• Work closely with Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Drug Safety, Project Management, and Regulatory to ensure operational excellence for assigned products/programs.

• Engage in regular Clinical Data Operations team meetings and offer input as appropriate.

• Contribute to or lead departmental process improvement initiatives, which may include the creation of data management SOPs, Work Instructions, and process documents.

• Onboard and/or train new employees and/or contractors.

• Stay updated on regulatory requirements and industry best practices in relevant areas of CDM, Third Party Vendors, related data sources/deliverables, technological advances, and quality assurance.

⛳️ Requirements

• A Bachelor’s degree is required, preferably in a scientific or healthcare field.

• Minimum of five years of experience in Clinical Data Management and/or sample management/third party data sources and/or Clinical Operations within the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment, including experience as a study lead.

• Familiarity with third-party data/deliverable sources, including laboratory sample management.

• Comprehensive understanding of regulatory guidelines and industry standards pertaining to third-party data/deliverables.

• Strong project management skills with a demonstrated ability to prioritize multiple tasks effectively.

• Attention to detail and capability to work independently, collaboratively within a multi-disciplinary team, and with external partners and vendors.

• Experience working with a globally distributed team.

• Excellent communication and interaction skills, with experience in a dynamic and growing organization.

• Familiarity with Risk Based Monitoring principles and the ability to apply critical thinking to assess and manage risk on assigned studies.

• Strong leadership skills with a proven ability to enhance team productivity and cohesiveness.

• Proficient written and verbal communication skills in English.

• Solid technical and computer system skills, with a strong aptitude for learning various computer applications.

• Prior experience with various Data Management/Clinical Study systems and technologies, including Electronic Data Capture systems, is desirable.

• Willingness to travel for off-site meetings or training seminars as required.

🏝️ Benefits

• Participation in Parexel’s annual performance-based bonus plan.

• Annual salary review.

• Total rewards incentives.