Project Manager

PE Global is recruiting a Project Manager for our pharmaceutical client based in Wrexham, the role is hybrid (4 days onsite p/month) and is a 12-month contract.

Responsibilities of the role:

Trial support

• Maintain trial organisation, keep records and reports up to date
• Supporting trial process and compliance
• Ensuring regulatory requirements and company policies are being followed with high attention to record documentation
• Support communications with external clients/partners
• Co-ordinating travel arrangements
• Planning and scheduling of meetings
• Supporting senior managers with clerical tasks

Scientific support

• Support writing and reviewing of study documents (protocol, statistical analysis plan, reports)
• Support drafting and coordinate submission of scientific publications, including posters and peer-reviewed articles.
• Support the team by coordinating the engagement with regulatory agencies (EMA, FDA) regarding qualification of novel eCOA/digital biomarkers.
• Support drafting of presentations and creation of figures and visuals, for both internal and external dissemination, according to company guidelines.
• Perform weekly and ad hoc literature searches of therapeutic areas of interest, digital health technologies and best practices and update the team on new developments.
• Keep abreast of updates on regulatory guidance concerning electronic data collection, digital biomarkers and outcome measurement and decentralized clinical trials.

Requirements:

• Life-science graduate with research and/or project management experience in public or private sector
• The candidate must have strong technical writing skills and digital literacy
• Strong interest in digital health technologies applied to drug development, outcome measurement science and regulatory affairs.
• Proactive and creative; problem-solver and pragmatic, but with a broad vision to improve processes and share knowledge.
• Team player
• High digital proficiency
• Excellent verbal and written communication skills – especially technical writing
• Strong organisational and time-management skills
• Strong presentation and public-speaking skills
• Ability to collaborate with others
• Relevant experience of a similar role

Please note PE Global is unable to provide sponsorship to any candidates for this role. Candidates will need to have their own visa to live and work within the UK for at least the next 12 months.