Senior Clinical Project Manager

WORKING AT MÖLNLYCKE
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 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 should apply for this exciting opportunity that we have below.
We are currently recruiting for a Senior Clinical Project Manager.
The role will be a key contributor in the development, execution, reporting and completion of Molnlycke sponsored global clinical projects according to set budget and timeline.
The role represents specialist competence within Clinical studies planning, conduct and closure as well as global and local regulations in the area.


Key Accountabilities:
Being part of cross functional teams, to lead clinical projects within and outside M&E.
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 through e.g. processes, systems, templates, instructions and standardization as well as review and update of applicable SOPs.
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 in the analysis of clinical data and being accountable for the Clinical Investigation Report activities.
Accountable for documentation management in regards to clinical studies.
Take appropriate action on Vigilance reporting, safeguard the quality of the study and escalate compliance issues via the appropriate channels.

Key Decisions:
Project Excellence optimisation and implementation
Investigation Plan input
Site/investigator/vendor selection and management
Contract management
Investigation Report input
Clinical investigation budget and timelines
From a clinical study perspective responsible for compliance with internal and regulatory guideline such as FDA, MDR, ISO and MDCG guidelines.

Capabilities, Qualifications and Experience:
Relevant (Life science) education on MSc level
Minimum 10 years of experience in Clinical Project/Study Management (Medtech, Pharma, CRO, academia) in an international setting, preferably a mix of companies/settings
Experience in driving change and improvement projects with solution oriented mindset
Proven track record of working in cross functional teams
Solid experience of managing various study types eg, Sponsored clinical investigations, Investigator initiated studies, pre-market clinical studies, post-market clinical follow-up studies etc.
Good net-working and organizational skills as well as entrepreneurial sense of ownership and execution.
Strong negotiation and communication skills and ability to work with various stakeholders, subcontractors and partners.
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)


About Mölnlycke
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 specialise 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.