Parexel

Manager, Centralized Data and Sampled Management

Parexel

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇬🇧 United Kingdom

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Job Level

Mid-LevelSenior

About the role

  • Manage the sample and external data transfers and associated activities for assigned studies across the sponsor portfolio.
  • Facilitate effective internal and external relationships.
  • Contribute to the development and growth of the Clinical Data Operations Team.
  • Lead the planning and oversight of clinical samples and external data sources for assigned studies, ensuring effective management of related procedures and deliverables.
  • 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
  • Open and friendly work environment
  • Opportunities to develop long-term careers

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
Clinical Data ManagementSample ManagementData Transfer AgreementsReconciliationRisk Based MonitoringProject ManagementRegulatory GuidelinesData Management SOPsElectronic Data CaptureStatistical Programming
Soft skills
Attention to DetailCommunication SkillsLeadership SkillsCritical ThinkingTeam CollaborationProblem SolvingOrganizational SkillsTraining and OnboardingAdaptabilityInterpersonal Skills