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.
Here are a few requirements specific to this advertised role.
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 distribut
Benefits
Health insurancePerformance bonus
Additional Information
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel is currently seeking a Manager, Centralized Data and Sampled Management to join us in South Africa, Poland or UK dedicated to a single sponsor.
The Manager, Centralized Data and Sampled Management will be responsible for managing the sample and external data transfers and associated activities for assigned studies across the sponsor portfolio. This role will facilitate effective internal and external relationships and will be expected to contribute to the development and growth of the Clinical Data Operations Team.
Working as Manager, Centralized Data and Sampled Management at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work.
Expect exciting professional challenges in inspiring studies, but with time for your outside life.
Base Pay Range for Poland: PLN 200,000 to 292,500.
Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location.
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.
Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles.
Parexel · United Kingdom