Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical and play a vital role in the setup, execution, and management of clinical trials. We challenge our team to bring thought-provoking ideas to the table and to help define and drive solutions for clients and patients. Join us in our mission to improve patient outcomes and make a difference in the field of clinical research.
Role Objectives:
As a Senior Clinical Project Manager at WEP Clinical, you will be responsible for the setup, implementation, and management of clinical trials, with a keen focus on patient safety, data integrity, high-quality operations, and exceptional customer service.
The Ideal Candidate:
- Team Player
- Adaptable
- Detail Oriented
- Problem Solver
What You'll Do:
- Serve as clinical trial project team lead.
- Manage the setup, execution, and close-out of clinical trials in compliance with WEP Clinical SOPs, GCP/ICH guidelines, and other regulatory requirements.
- Act as the primary contact with the client for clinical trial operations, deliverables, and issues; lead recurring internal and external calls.
- Oversee day-to-day trial operations, ensuring accountability as defined by the contract and according to laws and regulations.
- Provide cross-functional oversight of project team members and deliverables, including monitoring, site management, data management, pharmacovigilance, medical writing, and regulatory activities.
- Develop and maintain study manuals and operational project plans, including detailed timelines and key performance indicators or metrics.
- Engage all stakeholders to identify, assess, mitigate, and manage risks.
- Ensure internal and external teams are adequately trained on the operational aspects and therapeutic areas of the clinical trial.
- Manage submissions to IRB/ECs and review local informed consent forms.
- Proactively identify and resolve issues, implementing solutions and proposing corrective actions where necessary.
What You'll Need:
- Bachelor's Degree (In a health or science field preferred)
- 5+ years’ experience in project management, clinical trials, and/or clinical research, (or equivalent combination of education, experience, and expertise)
- Computer literacy and proficient in Microsoft Office
- Effective verbal and written communication skills
- Ability to manage multiple priorities
- Working knowledge of current ICH GCP guidelines
- Ability and willingness to travel up to 20% of the time
What We Offer:
- Medical, dental, and vision insurance
- Short-term disability insurance
- Life insurance
- Voluntary Long-term disability insurance
- 401K safe harbor plan and company match
- Paid vacation, holiday, sick, and volunteer time
- Paid maternity & paternity leave
- Personal Development Allowance
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 a decade of experience distributing products worldwide to treat unmet patient needs.
We're Committed to Our Team:
WEP has many initiatives in place to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, 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:
- Expanded Access Programs (EAPs)
- Open Label Extension Studies (OLE)
- Named Patient Programs (NPPs)
- Clinical Trial Supplies (Comparator & Ancillaries)
- Wren Nursing (Clinical Trial Home Nursing & Clinical Education)
- Hospital Supply of Unlicensed Medicines
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.
