- 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.
- Annual bonus in addition to your monthly salary and attractive benefits
- A dynamic team in an innovative global company
- Open, friendly and ever-changing work environment where you will get space for your ideas and are encouraged to take challenges and grow
- Careful and comprehensive induction
- Active field presence and regular customer visits
- The opportunity to help make patients' life better
- Relevant (Life science) education on MSc level
- Bachelor's degree in a related specialty required
- Minimum 10 years of experience in Clinical Project/Study Management (Medtech, Pharma, CRO, academia) in an international setting, preferably a mix of companies/settings. Wound care preferable.
- 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)
Sr. Clinical Project Manager - Norcross, United States - Mölnlycke Health Care
Description
The role will be a key contributor in the development, execution, reporting and completion of Molnycke 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.
Location: Remote, Must be located near a major airport.
What you'll do
What you'll get
What you'll need
Our approach to diversity and inclusion
At Mölnlycke diversity is not just a vision, but our strength. We are dedicated to fostering an inclusive workplace that values and celebrates the power of diversity. At the heart of our commitment is the belief that diversity fuels innovation, creativity, and problem-solving. We invite you to be a part of a team where authenticity is embraced, and every employee, regardless of background or any other traits, experiences a true sense of belonging
We welcome applications from those who do not meet every criteria on the requirements list. Attitude, drive, enthusiasm, and willingness to learn are also important to us
About Mölnlycke
Mölnlycke is a world-leading medical products and solutions company that equips healthcare professionals to achieve the best patient, clinical and economic outcomes.
Our business is organized into four business areas Wound Care, Operating Room Solutions, Gloves, and Antiseptics, where customer centricity, sustainability, and digitalization are at the heart of everything we do.
Mölnlycke employs around 8,400 people. The company headquarters are in Gothenburg, Sweden and we operate in more than 100 countries worldwide. Since 2007, the company has been part of Investor AB, an engaged owner of high-quality, global companies which were founded by the Wallenberg family in 1916. For more information, please visit and