Senior Clinical Study Manager

Key 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 [Employer hidden]’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 [Employer hidden] 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 [Employer hidden] 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 & Experience:

• 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

Qualifications/Education:

• Bachelor’s degree required, preferably in life sciences, medicine, or related discipline.

Travel Requirements

• Position may involve periods of travel up to 50% during study start-up and close-out.

Working Conditions:

• Remote working model