Clinical Project Manager/CRA – Expanding Biotechnology Company - Sweden
My client is a small Biopharmaceutical company based in Sweden who are currently seeking an experienced Clinical Project Manager to take on a position with varied responsibilities. We need an experienced project manager, who is also happy to carry out some work of a CRA.
My client currently has 2 x Phase I studies and is looking to progress further and needs the correct person in place to achieve the results required.
With an outstanding team of 6, you will be involved with a very tight and well organised team. There will be an expectation to hit the ground running and assist the team when required.
This is an opportunity to join a rapidly expanding biopharmaceutical company and to join an innovative and flexible team with great career progression. As a small company, they can be very flexible with what they offer in terms of responsibilities and full package.
Some of your responsibilities may include:
• Formulation of clinical protocols and related documentation in collaboration with the Clinical Operations Team (COT)
• Lead and matrix manage the global multidisciplinary COT to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures
• Identify sites and manage study set-up
• Lead the clinical trial protocol development process
• Responsible for ordering and management of clinical trial materials
• Support the CRA on study related questions and serve as point of contact for managing/ answering questions relating to trial procedures and subjects eligibility
• Responsible for set up and maintenance of the Trial Master File for assigned studies
• Regularly update all trial information databases in order to manage accuracy of information
• Approve for all necessary centre payments
• Co-ordinate pre-audit activities for nominated projects
• Contribute to identification and evaluation of new centres suitable for performing TM studies in healthy volunteer and patients.
• 5 years’ experience as a Project Manager
• Life Science Degree
• Motivates staff and ensures team effectiveness through eliciting feedback
• Previous experience in a small company is preferred
• Ability to be flexible and innovative as needed in a small company and small team
• Previous experience in the management/coaching of direct reports.
To find out more, please email email@example.com or call +44 (0) 203 778 0909