Our client is a global Clinical Trials Supplier that specialise in unlicensed medicine distribution and Expanded Access Programs. They are a steadily growing business with a highly dynamic and supportive team working on an exciting project portfolio. They offer autonomous working and an exceptional career progression and development plan within the Quality function.
Our client is looking for a Director of Project Manager to lead their EAP distribution Project Management team in London. Responsibilities include:
* Oversee and manage regional PMs and be accountable for the successful delivery of projects
* Ensure all EAP programs project plans including timelines and budgets are developed and operate within compliance
* Responsible for project team's leadership, training and operational oversight
* Responsible for building and maintaining positive client relationships
* Ability to negotiate with clients to assure the company's EU operational processes are maintained and projects are delivered within scope
* Oversight of the development and documentation of study-specific training requirements to assure project-level compliance across EAP Programs
* Responsible for preparation and finalization of EAP Out of Scopes (OOS). This includes ensuring that Project Teams are identifying OOS effectively and developing the effective change orders for finance
* Responsible for Performance Evaluations of Direct Reports
* Oversight of all documentation for the Electronic Trial Master File required for Expanded Access Programs, including case report forms and completion guidelines, informed consent documents, investigator agreements, investigator brochures, logic checks and data handling guidelines, and all other documents as required by the client
* Through a continuous methodology process, assist with developing, documenting, and updating internal company processes and processes required for consistency across programs such as SOPs, working practices, and related quality assurance forms
* Assists in the development and delivery of proposals for bid defences and capability presentations to prospective clients
* Participates in the performance appraisal program by providing timely and accurate feedback regarding the performance of respective team members
* Maintains current knowledge of MHRA regulations and cGDP Guidelines for Expanded Access Programs
* Degree in a health-related field with a minimum of five (5) years direct clinical trial or EAP experience with a minimum of two (2) years' experience managing teams
* Demonstrated competency with MS Excel, Word, Power Point etc
* Effective verbal and written communication skills
* Ability to handle extremely confidential information with complete discretion
* Strong organisational skills
What should you do next?
This role is one not to be missed; it encompasses the opportunity to work in a new senior position in a growing business. To discuss further, please submit your current CV. Unless otherwise stated, if applying for a job within the European Union, you must ensure that you are already authorised to work there. Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.