WEP Clinical

Associate Director, Project Management – Clinical Research

WEP Clinical

full-time

Posted on:

Location Type: Remote

Location: United States

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About the role

  • Lead and oversee the project management team, including training, development, and performance reviews.
  • Ensure project teams manage programs in accordance with WEP Clinical SOPs, policies, and regulatory requirements.
  • Oversee regional and global programs, ensuring successful delivery on time and within budget.
  • Develop and monitor program plans, timelines, and budgets in compliance with Statements of Work (SOW).
  • Identify, evaluate, and mitigate program risks, communicating issues to management and clients as needed.
  • Support Business Development, Contracts, and Finance teams with contracts, change orders, invoicing, and proposals.
  • Maintain knowledge of US, UK, EU regulations, GxP/ICH guidelines, and ensure GMP/GDP, GCP/ICH compliance.
  • Document and update internal processes, SOPs, and working practices for consistency across programs.
  • Produce performance reports for Senior Management and build strong client relationships.
  • Lead issue resolution, identify new client opportunities, and support vendor evaluation and selection.

Requirements

  • Bachelor’s Degree (in a health or science field preferred)
  • 5+ years’ experience in clinical research or project management, with at least three (3) to four (4) years direct clinical trial or Expanded Access Programs experience in a CRO or research related organization with at least one (1) year line management experience
  • Computer literacy and proficiency in Microsoft Office, as well as experience with an eTMF and CTMS
  • Ability to handle confidential information with complete discretion
  • Ability and willingness to travel up to 20% of the time
  • Knowledge of clinical research process from Phase I through regulatory submission
  • Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
  • Ability to set baseline targets, track trends, and implement mitigation plans
  • Understanding of basic data processing functions, including electronic data capture
  • Working knowledge of current ICH GCP guidelines
Benefits
  • Medical, dental, and vision insurance, FSA, HSA
  • Voluntary short-term and long-term disability insurance
  • Voluntary life insurance
  • 401K safe harbor plan and company match
  • Paid vacation, holiday, and sick time
  • Paid maternity & paternity leave
Applicant Tracking System Keywords

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

Hard Skills & Tools
project managementclinical trial managementrisk evaluationprogram planningbudget managementdata processingelectronic data captureGMP complianceGCP complianceSOP documentation
Soft Skills
leadershipcommunicationproblem-solvingclient relationship managementteam coordinationdiscretionpositive attitudeperformance evaluationtraining and developmentissue resolution