Clinical Trials Lead – Medical Devices

Coloplast A/S; Denmark; On-site; DKK 700,000 - 900,000; Full time

Job summary

Coloplast A/S, a global leader in intimate healthcare, invites an Associate Clinical Manager to join the Clinical Execution team at HQ in Humlebæk. You will contribute to planning, managing, and executing clinical investigations across Chronic Care and Wound Care portfolios, collaborating with hospitals and health professionals worldwide.

In this role you will support study plans, site qualification, regulatory approvals, budgeting, and sponsor/investigator files. English fluency is required.

Qualifications

• Hold a degree within life sciences, applied sciences, nursing or similar.
• Have experience with clinical investigations of medical devices or pharmaceuticals.
• Are familiar with the guidelines and directives within clinical research.
• Possess project management proficiency and can stay on budget.
• You are fluent in spoken and written English.

Responsibilities

• Contribute to the development of clinical investigation plans and study-related materials and assist with budget forecasting
• Support site identification, investigator qualification, selection, and training activities
• Support the process of obtaining approvals from health authorities and ethics committees
• Assist in monitoring and coordinating field monitors and contract research organisations
• Help ensure patient recruitment remains on track
• Prepare, maintain, and archive sponsor and investigator site files
• Support the planning and oversight of study material packaging to maintain accountability throughout the investigation

Skills

Stakeholder management

Project management

Budgeting

English language

Education

Degree in life sciences/applied sciences/nursing

Job description

Coloplast A/S, a global leader in intimate healthcare, invites an Associate Clinical Manager to join the Clinical Execution team at HQ in Humlebæk. You will contribute to planning, managing, and executing clinical investigations across Chronic Care and Wound Care portfolios, collaborating with hospitals and health professionals worldwide.

In this role you will support study plans, site qualification, regulatory approvals, budgeting, and sponsor/investigator files. English fluency is required.