Senior Clinical Project Manager

Mölnlycke Health Care

Senior Clinical Project Manager

Mölnlycke is a world-leading medical solutions company. We design and supply solutions to enhance performance at every point of care – from the hospital to the home proven it every day. We specialize in: • Wound management: including dressings with Safetac® such as Mepitel® and Mepilex® • Preventing pressure ulcers: with Mepilex® Border used prophylactically and devices to help turn and re-position patients • Surgical solutions: including Mölnlycke trays, HiBi® antiseptics and Biogel® surgical gloves Mölnlycke was founded in 1849. Nowadays our solutions are available in around 100 countries; we’re the number one global provider of advanced wound care and single-use surgical products; and we’re Europe’s largest provider of customised trays. Our headquarters are in Gothenburg, Sweden and we have about 7,800 employees around the world. For more information, please visit: www.molnlycke.com

Are you looking for a great career and want to make your mark?

Please keep on reading but don’t just take our word for it.

We’ve interviewed colleagues around the world about their jobs, the Mölnlycke unique culture and the Mölnlycke people and it is simply a great company to work for!

Could you help improve healthcare outcomes around the world?

If the answer is yes, you think just like us and then you should apply for this exciting opportunity as:

Senior Clinical Project Manager

We are currently recruiting a Senior Clinical Project Manager who will be a key contributor in the development, execution, reporting and completion of Mölnlycke’s sponsored global clinical projects. The role represents specialist competence within clinical studies in planning, conduct and closure as well as global and local regulations in the area. As Senior Clinical Project Manager you will be a key member in cross functional teams and be the lead of clinical projects within and outside of the department Medical & Economic Affairs. You will join an international team of Clinical Project Associates and Managers and will function as a mentor within the team. You will also be a key person in improvement projects within the department. 

 

Key Accountabilities

  • Accountable for actively explore and implement innovative and efficient ways of generating clinical evidence as well as, propose and implement improvements of the way projects are executed.
  • Accountable to drive the development of clinical investigation plans with focus on practical feasibility regarding design, timelines, country/site/investigator selection and budget.
  • Accountable for compliant/efficient execution of clinical studies and to ensure regular and timely progress reporting thereof.
  • Accountable for applicable Submissions (e.g., Competent Authority, Ethics Committee/Institutional Review Board).
  • Accountable for contract management as well as vendor and site management.
  • 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.
  • Ensure compliance, from a clinical study perspective, with internal and regulatory guideline such as FDA, MDR, ISO and MDCG. 

 

Qualifications

  • Relevant (Life science) education on M.Sc. level
  • Minimum 10 years of experience in Clinical Project/Study Management from Medtech, Pharma, CRO or academia in an international setting, preferably a mix of companies/settings
  • Solid experience in managing various study types (sponsored clinical investigations, investigator-initiated studies, pre-market clinical studies, post-market clinical follow-up studies)
  • Ability to, and experience of, transforming complex regulations/guidelines into lean processes and way of working
  • Knowledge in national and international requirements and regulations within the area of clinical studies for medical devices
  • Basic understanding in statistics, data management and scientific writing
  • Fluent in English (written and spoken)

The person we are looking for has a vast experience in driving clinical studies as well as experience in driving change and improvement projects 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!

To apply

This recruitment is handled by H&P Search & Interim. Please contact us for more information. Alternatively, you can apply directly by uploading your resume and sending us an email.

We look forward to your application!

H&P Search & Interim

Torbjörn Ströberg, torbjorn.stroberg@hpsearch.se, tel 0703-778 774

Karin Tomin, karin.tomin@hpsearch.se, tel 0726-013 619

Catharina Bergold, catharina.bergold@hpsearch.se, tel 0702-179 879