- Clinical Trial Project Manager
- Exciting, growing Pharmaceutical Company.
- West London based.
- £40,000 plus a competitive bonus, pension and healthcare structure in place.
Alex Dobson is recruiting for an exciting opportunity that is ideal someone with a GCP and ICH background working with a leading Expanded Access and Name Patient Programme organisation. For this position you will be the primary point of contact for clients, managing all aspects of the delivery of the project as well as providing advice and guidance.
The company are a young, ambitious, small to medium sized pharmaceutical company based in West London. As an organization they focus on providing patients with untreated medical needs who have tried all the available treatment options. They offer EAP options that can help life-threatening illnesses that can allow them to go into new treatment options. In addition to this they offer the NPP programme which give access to unlicensed or unavailable medicines to patients around the world. They are looking to expand their middles management team and have a role for an exceptional candidate with a background in Project Management.
We are looking for a high calibre with professional with Expanded Access or Compassionate Use access to pre- approval medicines.
As a Project Manager you will be accountable for the setup, implementation and delivery of Expanded Access Programs for Pharmaceutical and Biotech Companies. You will be the primary point of contact for clients, managing all aspects of the delivery of the project as well as providing advice and guidance. This is a pivotal role and requires a strong customer focus and attention to detail as well as the ability to develop and execute project plans, track against KPIs, identify risk and contingency planning.
Key Accountabilities/Responsibilities will include the following:
- Working with Sponsor and internal teams to implement and execute devised project plans.
- Researching and understanding new territories by country regulations for project implementation.
- Order Management, process design and implementation.
- Logistics & stock management - liaising with couriers & external partners.
- SOP management and review (with support from Quality function).
- Country specific regulatory submissions.
- Handling queries and management of issues.
- Management of shipping documents, customs queries.
- Order processing.
- Client first port of call for project status and updates.
As a Project Manager, you will have the following qualifications, skills and experience:
- Educated to degree level within Life Sciences (biological science, pharmacy or other health related discipline preferred) or equivalent nursing qualification / experience.
- Experience managing multiple projects with different customers.
- Account management / service sector background preferred.
- Strong interpersonal skills and ability to motive members with in a matrix system.
- Strong knowledge of ICH, GCP, and the UK clinical trials environment/ drug development process.
- 2nd language (other than English) is advantageous.
- Previous experience in a project management role, with projects requiring specific deliverables of logistics, external & internal communication plans, supply chain, regulatory (ideal) and KPI measures.
- Excellent planning and organizational skills.
- Ability to communicate at all levels.
Pharmacy, Pharmaceutical, Biotech, Life Sciences, Project Manager, Clinical Trial, Expanded Access, Compassionate Use, Clients, ICH, GCP, SOP, Drug Development West London, Chiswick, Brentford, Acton, Middlesex.
This is a permanent position.