Position Overview
The Senior Clinical Study Manager (Sr. CSM) plays a key role in the success of Convatec’s clinical trials, overseeing planning, execution, and completion. The Sr. CSM leads teams, manages budgets, and ensures projects align with organizational goals. Responsibilities include developing project plans, managing resources, mentoring junior team members, and coordinating day‑to‑day clinical trial operations. The Sr. CSM ensures studies are conducted efficiently, effectively, and in compliance with ICH GCP guidelines, local regulatory requirements, and Convatec’s policies and SOPs.
Key Responsibilities
* Proactively manage assigned clinical studies.
* Ensure overall study efficiency and adherence to project timelines and budgets; report metrics to Head Global Clinical Operations as required.
* Analyze and manage study risks, proposing solutions for risk mitigation.
* Provide regular progress reports for study activities through ongoing tracking and review of 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 study team.
* Handle escalations for study management questions and issues.
* Work closely with data management, clinical site management, quality assurance and biostatistics to support milestone achievement.
* Manage third‑party clinical monitoring vendors when 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, track expenses, and ensure projects stay within allocated financial resources.
* Ensure compliance with applicable SOPs, guidelines, and regulations for all study phases.
* Monitor vendor performance against contractual deliverables.
* Drive performance, quality, timelines, and relationships in partnership with CROs and vendors.
* Manage study scope, quality, timelines, and budgets with internal leads, CROs, and vendors.
* Build professional relationships with key opinion leaders and clinical site staff to support study enrollment.
* Plan and conduct investigator meetings with CRO or Convatec event planners.
* Support the CRO and CRA to ensure effective patient enrollment strategies.
* Evaluate issues, implement solutions and mitigation plans.
* Create risk assessments and mitigation plans, performing regular reviews to adapt to changing circumstances.
* Provide clinical operations input into protocols, investigator brochures, regulatory documents, study reports, and other documents as appropriate.
Skills & Experience
* Minimum of 5 years independently managing clinical trials.
* Experience in the medical device industry and/or wound care, dermatology or related therapeutic areas.
* Prior study management experience.
* Comprehensive understanding of site assessment and qualification.
* Ability to monitor and report study progress from start‑up to completion.
* Extensive experience in site evaluation, initiation, interim, and close‑out visits.
* Advanced knowledge of federal regulations governing research and GCP standards.
* 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.
Equal Opportunities
Convatec provides equal employment opportunities for all current employees and applicants for employment. No discrimination on the basis of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
#J-18808-Ljbffr