Overview
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.
Responsibilities
- Lead and provide operational oversight for the project management team.
- Responsible for the project team’s training and development and performance reviews.
- Assure project teams are managing programs in accordance with WEP Clinical SOPs and Policies.
- Oversee and manage regional and global programs with accountability for successfully delivering projects on budget.
- Ensure all program project plans, including timelines and budgets, are developed in compliance with the Statement of Work (SOW).
- Proactively identify, evaluate, monitor, and mitigate program risks, as appropriate, and communicate identified risks to WEP Clinical management and clients.
- Support WEP Clinical Business Development, Contracts and Finance teams with contracts, change orders and monthly invoicing.
- Oversee all project operations and services and ensure compliance with GMP/GDP, GCP/ICH, and regulatory requirements.
- Maintain current knowledge of US, UK, and EU regulations and GxP/ICH Guidelines for EAP/PA-NPP and clinical research.
- Develop, document, and update internal WEP Clinical processes, such as SOPs, working practices, and related forms, required for consistency across programs.
- Produce update reports for Senior Management on the performance metrics of each program.
- Build and maintain positive client relationships.
- As required, oversee and lead the WEP Clinical PM team with issue management and resolution.
- Identify new opportunities within the existing client base and relay them to the BD team.
- Identify potential vendors and participate in the vendor evaluation and selection process in collaboration with WEP Clinical Quality.
- Assist in developing and delivering proposals for bid defences and capability presentations to prospective clients.
- Supports Contracts and Proposals with final project contract execution and change orders
Qualifications
- Bachelor’s Degree (in a health or science field preferred).
- Direct clinical trial or Expanded Access Programs experience in a CRO or research-related organization with basic knowledge or exposure to line management.
- Computer literacy, proficiency in Microsoft Office, and experience with an eTMF and CTMS.
- Ability to handle confidential information with complete discretion.
- Strong organizational skills and attention to detail.
- Ability and willingness to travel up to 20% of the time.
- Effective verbal and written communication skills.
- Knowledge of the 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.
- Proactive and solutions-driven, with the ability to meet multiple tasks and deadlines with high accuracy.
- Ability to reason independently to assess and recommend specific solutions in clinical settings.
- 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 You'll Need
- Bachelor’s Degree (in a health or science field preferred).
- Direct clinical trial or Expanded Access Programs experience in a CRO or research-related organization with basic knowledge or exposure to line management.
- Computer literacy, proficiency in Microsoft Office, and experience with an eTMF and CTMS.
- Ability to handle confidential information with complete discretion.
- Strong organizational skills and attention to detail.
- Ability and willingness to travel up to 20% of the time.
- Effective verbal and written communication skills.
- Knowledge of the 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.
- Proactive and solutions-driven, with the ability to meet multiple tasks and deadlines with high accuracy.
- Ability to reason independently to assess and recommend specific solutions in clinical settings.
- 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
- Private healthcare insurance
- Long-term illness Cover
- Death in service cover
- Salary sacrifice pension
- Annual leave
- Paid maternity & paternity leave
- Volunteer day
- Great social events
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 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
- 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.
Seniority level
Employment type
Job function
- Project Management and Information Technology
- Industries
- Pharmaceutical Manufacturing
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