Associate Director, Project Management (Clinical Research)

WEP Clinical is a growing company in the pharmaceutical industry, seeking an Associate Director of Project Management to oversee critical projects. The role involves managing Expanded Access Programs and ensuring compliance with regulatory requirements while leading a project management team.

Responsibilities:

• 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