At a Glance
- Tasks: Lead clinical sample management and data transfers for exciting studies.
- Company: Join Parexel, a leader in the pharmaceutical industry with a global presence.
- Benefits: Competitive salary, performance bonuses, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on innovation and continuous improvement.
- Why this job: Make a real impact in clinical research while working from home.
- Qualifications: Bachelor’s degree and 5+ years in Clinical Data Management or related fields.
Overview
Parexel is currently seeking a Manager, Centralized Data and Sampled Management to join us in South Africa, Poland or the UK.
The role will be responsible for managing sample and external data transfers for assigned studies across the sponsor portfolio.
Key Responsibilities
- Lead planning and oversight of clinical samples and external data sources for assigned studies, ensuring effective management of procedures and deliverables.
- Understand trial‑specific requirements for external data sources and logistics; advise on provider contracting.
- Develop sample management plans 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 set‑up (labs, imaging).
- Ensure study team is 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, identify trends, and propose remedies.
- 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 electronic Trial Master File (e TMF).
- Coordinate closely with Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Drug Safety, Project Management, and Regulatory to ensure operational excellence.
- Participate in regular Clinical Data Operations team meetings and provide input when appropriate.
- Contribute to or lead department process improvement initiatives, including 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 related to CDM, third‑party vendors, and data sources.
Qualifications
- Bachelor’s degree required; degree in scientific/healthcare fields preferred.
- At least five years of experience in Clinical Data Management, sample management, third‑party data sources, 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.
- Comprehensive understanding of regulatory guidelines and industry standards related to third‑party data/deliverables.
- Good project‑management skills and proven ability to prioritize across multiple tasks.
- Attention to detail and ability to work individually, within a multidisciplinary team, and with external partners and vendors.
- Experience working with a globally distributed team.
- Strong written and verbal communication skills in English.
- Growth‑orientated, strong computer and technical skills, with the ability to learn multiple computer applications; prior experience with different Data Management/Clinical Study systems and Electronic Data Capture systems is desirable.
- Experience with 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.
- Ability to travel to off‑site meetings or training seminars as needed.
Compensation & Benefits
Base Pay Range for
Actual salaries may vary within the range based on education, training, experience, professional achievement, and location.
Additional benefits may include participation in Parexel’s annual performance‑based bonus plan, annual salary review, and total rewards incentives.
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StudySmarter Expert Advice🤫
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We think you need these skills to ace Manager, Centralized Data & Sample Management - UK , Poland or South Africa (Home-based) - FSP
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✨Brush Up on Lab Techniques
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