Associate Director - Project Management (Clinical Research)

Are you a professional with strong initiative and excellent problem-solving skills? Do you aspire to make a meaningful impact in the pharmaceutical industry particularly in overseeing and executing critical projects? If so we have an exciting opportunity for you! Join our team at WEP Clinical as an Associate Director of Project Management and help us bring life-changing treatment solutions to patients worldwide. At WEP Clinical our business is growing and the career opportunities are limitless. We encourage our team to bring innovative ideas to the table. Join us and see how you can elevate your career while making a significant impact on the lives of patients!

Role Objectives:

The WEP Clinical Associate Director of Project Management is responsible for assisting with the oversight of program set up implementation and overall management of Expanded Access Programs (EAP) and/or Post-Approval Named Patient Programs (PA-NPP). The Associate Director is also responsible for the line management of assigned reports and for contributing to the development of departmental processes.

The Ideal Candidate:

• Excellent Communicator

• Proactive Leader

• Highly Adaptable

• A Problem Solver

What You'll Do:

• 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.

What You'll Need:

• 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

What We Offer:

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

What sets us apart:

WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.

We're Committed to Our Team:

WEP has many initiatives to encourage wellness growth and development and team relationships. Check out our LinkedIn Life Page to learn more about our team events and all that we do to support our employees.

We're Committed to DEI:

At WEP Clinical acceptance recognition and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth embracing everyone's unique identities.

Our services include:

Access Programs

Clinical Trial Services

Patient Site Solutions

Clinical Trial Supply

Market Access and Commercialization

WEP Clinical is a smoke-free drug-free and alcohol-free work environment.

WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race colour religion creed sex sexual orientation gender identity or expression national origin genetic information age disability marital status veteran status or any other status protected by applicable law. This policy applies to all terms conditions and privileges of employment including recruitment hiring placement compensation promotion discipline and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities in accordance with applicable law.