Manager, Centralized Data & Sample Management - UK , Poland or South Africa (Home-based) - FSP

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.

Responsibilities

• 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.

We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.

Who are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base. We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients. You’ll be an influential member of the wider team.

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