Clinical Operations Manager

Grow your career in an International Environment!

If you’re a team player who enjoys collaborating in a close-knit environment but likes the security and opportunities of a large organization, great news:

 

Molnlycke is hiring a Clinical Operations Manager in our Norcross office!

The Clinical Operations Manager will be vital in bringing clinically and commercially relevant research to life, aligning seamlessly with the company's strategic objectives while keeping things efficient and on track with projected timelines. As a supportive leader, you'll guide our clinical research team in prioritizing tasks and allocating resources. Your responsibility will also extend to fostering the professional growth of team members, helping them maintain top-notch skills and uphold best practices in all clinical research activities. This commitment is at the heart of meeting both current and future needs in line with our company's overarching strategy.

 

What you’ll do:

• Lead and uplift the Clinical Research team (including Sr. CPMs, CPMs, and CPAs) to ensure they achieve goals aligning with BA commercial strategies.

• Take ownership of guaranteeing our clinical studies run smoothly, meet forecasted timelines, and promptly address any concerns that may arise.

• Be the guardian of clinical research compliance, ensuring that all studies managed by your team adhere to the highest standards.

• Provide valuable input and recommendations for decision-making processes related to the clinical studies under your purview.

• Ensure that the clinical and commercial needs are not just met but exceeded, identifying any deviations from the standard of care.

• Personally handle operational activities within the studies, if applicable.

• Keep everyone in the loop with regular and timely progress reports, highlighting any potential risks, and championing continuous improvements in project management.

• Explore and implement innovative ways of generating clinical evidence, including adept vendor and contract management.

• Engage in proactive communication with cross-functional internal stakeholders (ME, CO, R&D, RA, QA, Operations, and Commercial organizations) to align on all evidence generation activities and optimize commercial impact.

• Foster effective communication and interaction with external stakeholders, such as clinicians, study sites, authorities, ethical committees, etc.

• Take the lead in improving existing processes and developing new ones, ensuring successful implementation of any enhancements.

• Actively contribute to the organization's clinical studies knowledge, identifying and addressing training needs for stakeholders/roles involved in the Clinical Study Process.

• Be the embodiment of Mölnlycke's high-performance behaviors within the team and department, setting the bar for excellence.

 

Work/Life Balance

• Hybrid Work schedule (2 days work from home!)
• Domestic & International Travel (20%)
• 4 weeks PTO, 4 Float Days and 1 Wellness Day

 

What you’ll get:

• Competitive Base Salary, Annual Bonus, Generous 401K
• Medical, dental and vision benefits starting Day 1 -plus Wellness Incentives!
• A Company that values YOU and your ideas!

 

What you’ll need:

• Bachelor’s Degree required.
• 10+ of experience in clinical research and people management in an international setting.
• Strong team builder with high flexibility, a positive attitude and able to lead and motivate people in a challenging environment.
• Proven experience of managing various study types within medical devices eg, sponsored clinical investigations, Investigator initiated studies, pre-market clinical studies, post-market clinical follow-up studies etc.
• Up-to-date, and in-depth, knowledge of national and international requirements and regulations within the area of clinical studies for medical devices.
• Ability to, and experience of, transforming complex regulations/guidelines into lean processes and way of working.
• In-depth knowledge of the clinical reality and patient pathway, preferably with an understanding of wound care and relevant challenges

 

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 l