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WEP Clinical · 21 hours ago

Associate Director, Project Management (Clinical Research)

Morrisville, NC

Full-time

Hybrid

Lead/Staff, Director/Executive

5+ years exp

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.

BiotechnologyInformation TechnologyPharmaceutical

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

Qualification

Clinical research experienceICH GCPProject management experienceMicrosoft Office proficiencyETMFCTMS experienceCommunicatorProactive leaderProblem solverHighly adaptable

Required

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