[Hiring] Senior Clinical Study Manager @Convatec

Role Description

The Senior Clinical Study Manager (Sr. CSM) plays a key role to the success of Convatec’s clinical trials. The Sr. CSM oversees the planning, execution, and completion of clinical trials, leading teams, managing budgets, and ensuring projects align with organizational goals. Responsibilities include:

• Proactively manage assigned clinical studies.
• Ensure overall clinical study efficiency and adherence to project timelines and budget; report metrics to Head Global Clinical Operations as required.
• Analyze and manage clinical study risks, propose solutions for risk mitigation.
• Provide regular progress reports for clinical study activities through ongoing tracking and review of study project plans.
• Coordinate production of key clinical study documentation including Clinical Investigation Plan (CIP), Investigator Brochure (IB), Informed Consent Form (ICF), and Clinical Study Report (CSR).
• Motivate and manage a multi-disciplinary clinical study team.
• Handle escalations for study management questions and issues for assigned projects.
• Work closely with other functional groups within Convatec’s Clinical Operations team such as data management, clinical site management, quality assurance, and biostatistics.
• Manage 3rd party clinical monitoring vendors as necessary.
• Build and develop relationships with key internal teams, including Medical Affairs and Medical Writing.
• Support audit and inspection activities as needed.
• Support adoption of best practices, updating processes and SOPs.
• Manage project budgets, tracking expenses, and ensuring projects stay within allocated financial resources.
• Responsible for managing the technical aspects for all phases of the clinical study to ensure compliance with applicable SOPs, guidelines, and regulations.
• Monitor and assess vendor performance against contractual operational deliverables.
• Drive performance, quality, timelines, and relationships in partnership with the CRO and other vendors.
• Manage study scope, quality, timelines, and budget with internal functional leads, CRO, and vendors.
• Build solid professional relationships with key opinion leaders and clinical site staff.
• Responsible for planning and conducting investigator meetings.
• Support the CRO and CRA to ensure patient enrollment strategies are conducted effectively and on time.
• Evaluate issues and implement solutions and mitigations as required.
• Create appropriate risk assessments and mitigation plans, perform regular reviews to continually assess changing circumstances.
• Review and provide clinical operations input into relevant clinical documents.

Qualifications

• Minimum of 5 years independently managing clinical trials is required.
• Experience in the medical device industry and/or wound care, dermatology or related therapeutic areas is required.
• Prior study management experience is required.
• Comprehensive understanding of how to properly assess an investigative site's capabilities for conducting clinical research.
• Ability to monitor and report on the progress of a clinical study from start-up to completion.
• Extensive experience in the conduct of site evaluation, initiation, interim, and close-out visits.
• Advanced knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs).
• Strong attention to detail.
• Excellent collaborative team player.

Requirements

• Bachelor’s degree required, preferably in life sciences, medicine, or related discipline.
• Position may involve periods of travel up to 50% during study start-up and close-out.

Working Conditions

• Remote working model.