Parexel

Manager, Centralized Data and Sample Management

Parexel

full-time

Posted on:

Location Type: Remote

Location: Poland

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Salary

💰 PLN 100,000 - PLN 150,000 per year

About the role

  • 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.
Benefits
  • annual performance-based bonus plan
  • annual salary review
  • total rewards incentives
Applicant Tracking System Keywords

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

Hard Skills & Tools
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