About The Role

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.

Role Objectives

The WEP Clinical Senior Project Manager is responsible for leading and overseeing the setup, implementation, and management of Post Approval Named Patient Programs (PA-NPP) and/or related projects.

The Ideal Candidate

Team Player
Adaptable
Detail Oriented
Problem Solver

What You'll Do

Lead and/or oversee regional and global PA-NPP or related projects, ensuring project timelines are met as per contract.

Ensure all program project plans, including timelines and budgets, are developed, maintained, and in compliance with the Scope of Work (SOW).

Responsible for the project team's leadership, training, and operational oversight, including overseeing delegation of support staff activities as necessary; may serve as line manager of direct report(s) in some instances.

Build and maintain positive client relationships, communicating with clients to ensure WEP Clinical operational processes are maintained and projects are delivered within scope.

Identify, evaluate, monitor, and mitigate any factors or processes that may threaten project quality (risk management), and communicate identified risks to internal team members, upper-level management, and clients as appropriate.

Develop, identify, define, and document study-specific training requirements to assure project-level compliance across projects.

Prepare and finalize Out of Scopes (OOS), ensuring Project Teams identify OOS effectively and develop effective change orders in collaboration with WEP Clinical Business Development.

Assure project teams are managing programs in accordance with WEP Clinical SOPs and Policies.

Participate in proposal meetings for potential clients.

Review documentation for the Electronic Trial Master File required for Programs, including treatment guidelines or protocols, case report forms and completion guidelines, informed consent documents, investigator agreements, investigator brochures, logic checks, data handling guidelines, and all other documents as required by the client.

In conjunction with management, assist with developing, documenting, and updating internal WEP Clinical procedures and processes required for consistency across programs, such as SOPs, working practices, and related quality assurance forms.

Provide operational oversight during Programs and projects, including reviewing site visit preparation documents, site visit reports, and site payments; audit the compilation and completion of the eTMF and CTMS; and maintain current knowledge of FDA, GDPR, and other global regulations and GCP/ICH Guidelines for Post-Approval Named Patient Programs and Clinical Research.

What You'll Need

Fluency in French is a requirement for this role

Bachelor's Degree (in a health or science field preferred)

Significant experience and demonstrated ability in project management or clinical research, with direct clinical trial or PA-NPP experience in a CRO or research-related organization

Computer literacy and proficiency in Microsoft Office, as well as experience with an eTMF and CTMS, and an understanding of basic data processing functions, including electronic data capture

Ability to handle confidential information with complete discretion

Strong organizational, interpersonal, and attention-to-detail skills, with the ability to manage multiple priorities and interact with all levels of staff to coordinate and execute study activities

Effective verbal and written communication skills, including the ability to express complex ideas

Knowledge of the clinical development process from Phase I through regulatory submission, and working knowledge of current ICH GCP guidelines

Ability to reason independently to assess and recommend specific solutions in clinical settings, and to set baseline targets, track trends, and implement mitigation plans