Clinical Trial Liaison / Clinical Research Lead
ICON plc
Google Cloud Platform
Senior Clinical Study Manager – Device
Convatec
full-time
Posted on:
Location Type: Remote
Location: Remote • Florida, Massachusetts, Virginia • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Proactively manage assigned clinical studies.
- Effectively manage clinical study delivery across the Clinical Study team during study start-up, routine monitoring, and closeout activities.
- Identify and escalate clinical study risks and propose solutions for risk mitigation.
- Oversee clinical study finance tracking, identify and escalate potential risks.
- Provide regular progress reports for clinical study activities through ongoing tracking and review of study project plans.
- Coordinate the production of key clinical study documentation, including Clinical Investigation Plan (CIP), Investigator Brochure (IB), Informed Consent Form (ICF) and Clinical Study Report (CSR).
- Motivate a multi-disciplinary clinical study team.
- Drive milestone achievement through management of study issues and conflict resolution with limited oversight.
- Oversee 3rd party Vendors where necessary to support milestone achievement.
- Build and develop relationships with key internal teams, including Medical Affairs and Medical Writing.
Requirements
- Bachelor’s or Master’s degree required, preferably in life sciences, medicine, or related discipline.
- Minimum of 10 years Clinical Research experience, preferably some within the medical device arena, with at least 5 years of experience in clinical study management.
- Strong knowledge of the clinical study lifecycle.
- Clinical study management skills, including the ability to manage timelines, budgets and resources effectively.
- Medical Device experience essential.
- Advanced knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs).
- Excellent collaborative team player.
- Experience in pre-market (IDE) and post-market clinical studies.
- Experience with Clinical Trial Management Systems.
Benefits
- Flexible working arrangements
- Professional development opportunities
- Health insurance
- 401(k) matching
- Paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical study managementclinical study lifecyclerisk mitigationfinance trackingtimeline managementbudget managementresource managementpre-market studiespost-market studiesGood Clinical Practices (GCPs)
Soft skills
collaborative team playerconflict resolutionmotivationrelationship buildingcommunication
