[Remote] Senior Clinical Study Manager

Note: The job is a remote job and is open to candidates in USA. Convatec is a global medical products and technologies company focused on solutions for chronic conditions. The Senior Clinical Study Manager will oversee the planning, execution, and completion of clinical trials, ensuring compliance with regulations and effective communication with stakeholders while mentoring junior team members.

Responsibilities

• 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
• Working closely with other functional groups within Convatec’s Clinical Operations team such as data management, clinical site management, quality assurance and biostatistics where necessary to support milestone achievement and to manage study issues and obstacles
• Manage 3rd party clinical monitoring Vendors where necessary to support milestone achievement and to manage study issues and obstacles
• 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
• Managing 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 (development though study close-out) for Convatec clinical studies to ensure compliance with applicable SOPs, guidelines, and regulations
• Responsible for managing risks, and monitoring progress to meet deadlines and stakeholder expectations
• Leading and motivating project teams, providing direction and support, and fostering a collaborative environment
• 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 the internal functional leads, CRO and vendors to ensure project objectives remain on track
• Build solid professional relationships with key opinion leaders and clinical site staff to support clinical trial enrolment and other activities
• Responsible for planning and conducting investigator meetings together with the CRO or Convatec meeting event planner
• 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 such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate

Skills

• 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 on how to properly assess an investigative site's capabilities for conducting clinical research. Knowledge of how to select and qualify an investigative site
• 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
• Bachelor's degree required, preferably in life sciences, medicine, or related discipline

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