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.
About the job
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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.