Clinical Project Manager, Mölnlycke
If you enjoy stretching yourself in a transformational environment, Mölnlycke could be the next step for you.
Clinical Project Manager
We are now recruiting a Clinical Project Manager who will be a key contributor in the development, execution, reporting and completion of Mölnlycke’s sponsored global clinical projects according to set budget and timeline. The role represents specialist competence within clinical studies in planning, conduct and closure as well as global and local regulations in the area. As a Clinical Project Manager you will join an international team of Clinical Project Associates and Managers, be part of cross functional teams and lead clinical projects within and outside of the department Medical & Economic Affairs.
- Accountable to drive the development of Clinical Investigation Plans with focus on practical feasibility (design, time plan, country/site/investigator selection, budget).
- Accountable for compliant/efficient execution of clinical studies and to ensures regular and timely progress reporting (resources, budget, timelines) thereof.
- Accountable for applicable Submissions (e.g., Competent Authority, Ethics Committee/Institutional Review Board).
- Accountable for contract management (negotiation, management, payments).
- Accountable for vendor and site management (e.g., selection, training, monitoring, follow-up).
- Oversee data management and contribute to the analysis of clinical data and being accountable for the Clinical Investigation Report activities.
- Accountable for documentation management regarding clinical studies.
- Take appropriate action on Vigilance reporting, safeguard the quality of the study, and escalate compliance issues via the appropriate channels.
- As part of the Clinical Operations team the role will actively contribute in team activities and process improvement projects in line with priorities (e.g. review and maintenance of applicable SOP).
- Relevant (Life science) education preferred MSc level and/or relevant experience in Clinical Project/Study Management (Medtech, Pharma, CRO, academia) with preferred wound care management
- Experience of managing various study types eg, Sponsored clinical investigations, Investigator initiated studies, pre-market clinical studies, post-market clinical follow-up studies etc.
- Knowledge in national and international requirements and regulations within the area of clinical studies for medical devices
- Good scientific writing capabilities
- Basic understanding in statistics and data management
- Fluent in English (written and spoken)
The person we are looking for has experience in driving clinical studies with a solution-oriented mindset. You have a proven track record of working in cross functional teams. You have good networking and organizational skills as well as an entrepreneurial sense of ownership and execution. You have a methodical and analytical approach and the ability to understand and analyze complex matters and make rational judgments and clear priorities. You have strong negotiation and communication skills and the ability to work well with various stakeholders, subcontractors, and partners.
Do not miss this exciting opportunity to join Mölnlycke, a world-leading medical products and solutions company that equips healthcare professionals to achieve the best patient, clinical and economic outcomes!
This recruitment is handled by Dedicare Life Science (formerly HP Search & Interim). Please contact us for more information. You can also apply directly by uploading your resume in English.
We look forward to your application!
Catharina Bergold & Torbjörn Ströberg