Clinical Project Associate

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 Project Associate in our Norcross office!

The Clinical Project Associate will support and contribute to the planning, conduct, and reporting of global clinical projects in accordance with applicable guidelines/laws, timelines, budget, and quality standards

• Accountable for study logistics and materials.
• Support clinical studies through assignment of study site visits, including qualification, initiation, monitoring, and close-out visits.
• Accountable for study documentation and archiving.
• Support or lead project management for study delivery.
• Support or lead compliant execution of clinical studies by being skilled in applicable Standard Operating Procedures (SOP), laws, and regulations.
• Support and improve administrative routines and procedures.

As part of Clinical Operations, this role will operate through internal and external cross-functional teams and involve stakeholders, experts, investigators, subcontractors, and authorities. The CPA will have an academic background that supports the key deliverables.

 

What you’ll do:

• Accountable for key documentation processes in clinical projects, i.e.
  • Develop and maintain the investigation files.
  • Archiving of databases and Investigation files.
• Accountable for study documentation and archive during audits.
• Accountable for management of investigational products, including but not limited to, ordering, warehousing, shipment and accountability.
• Accountable for study logistics, including but not limited to, study supplies, material acquisition, documentation printing.
• Support clinical studies through assignment of study site visits, including qualification, initiation, monitoring, and close-out visits.
• Take a lead role in selected tasks related to planning, conduct, and closure of clinical projects (e.g. development of Clinical Investigation Plan and Clinical Investigation Reports, site selection and follow-up, vendor management).
• Drive operational aspects of assigned tasks (e.g. CRO/site/lab selection, milestones, meetings, resource allocation, enrolment, data consistency, investigation products).
• Support project budget planning and forecasting.
• Review and maintenance of applicable SOP.

Work/Life Balance

• Hybrid Work schedule (2 days work from home!)
• The role may require up to 25% domestic and international travel; at times travel could require up to 50% depending on project timelines.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.
• Working experience in Clinical Research (Project/Study Management, Monitoring, etc.) preferred.
• Knowledge of clinical research methodology, GCP, and applicable regulations/laws.
• Clinical research experience in medical device industry preferred.
• Strong feeling of ownership and execution.
• Problem solver with a solution-oriented mindset
• Strong communication skills and ability to work with various stakeholders, subcontractors and partners.
• Comfortable working with multiple activities simultaneously and with short deadlines.
• Experience working in cross-functional teams.

 

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. Customer centricity, sustainability, and digitalization are at the heart of ever