Parexel

Manager, Clinical Operations – FSP

Parexel

full-time

Posted on:

Location Type: Remote

Location: Netherlands

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About the role

  • Manage integration of project team activities, leveraging internal and external resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge.
  • Provide input on trial level operational strategies for clinical trials from protocol design to the final clinical study report for specified studies
  • Provide input into global subject/patient recruitment plans.
  • Relationship management between study sites and vendors
  • Manage aspects of CRO/vendor identification and the day to day operational management activities of CROs & other vendors including set up, statement of work creation and budget oversight.
  • Manage strategic study operations including: study sites and tracking systems for regulatory submissions, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, all budgetary and financial information, performance metrics, data flow, etc.
  • Create and update critical trial-specific documents (for example country specific ICF) and plans
  • Support development of compound and protocol level training materials
  • Review and provide input into budgets, timelines, and forecasts for assigned clinical studies
  • Interface with internal key stakeholders including, but not limited to; Finance, Program Management, Vendor Management, Safety, Accounting, Clinical Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting as a liaison between groups.
  • Provide support for inspection readiness activities and on identification of risks and mitigation plans at the trial level
  • Participate in process improvement activities at a trial and department level as needed
  • Support onboarding of new team members
  • Attend CTWG and provide input and updates on operational activities and progress
  • Ability to travel (approximately10% but flexibility to go over or below as per business need.

Requirements

  • BS/ BA Degree is required.
  • 5+ years of clinical research experience gained with a CRO, Biotech, or Pharmaceutical Company working on Phase 1-4 global clinical trials.
  • 2-3+ years leading aspects of global clinical trials
  • Experience working with a CRO
  • Strong regulatory knowledge, including Good Clinical Practices (GCPs)
  • Strong decision-making, analytical and financial management skills are essential to this position
  • Proven ability to foster team productivity and cohesiveness and the ability to operate and execute with limited supervision
  • Experience in leading without authority and in multifunctional matrixed and global environments
  • Experience mentoring/ coaching others
  • Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability.
  • Strong project planning/ management, communication (written and verbal) and presentation skills
  • Experience with protocol, ICF, CRF, CSR development and review.
  • Proficient with MS Office Suite (Excel, Word and PowerPoint)
Benefits
  • Competitive salary
  • Flexible working hours
  • Professional development opportunities
Applicant Tracking System Keywords

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

Hard Skills & Tools
clinical researchproject managementregulatory knowledgeGood Clinical Practices (GCP)budget oversightprotocol developmentICF developmentCRF developmentCSR developmentdata flow management
Soft Skills
decision-makinganalytical skillsfinancial managementteam productivitymentoringorganizational skillsproblem-solvingcommunication skillspresentation skillsflexibility