Serves as the main point of contact at a country level for internal and external stakeholders
Coordinates country cross functional teams and acts as the main point of contact for a Country with the protocol manager and other global study team members
Coordinates with other internal roles in country and site feasibility process, including proposal and validation of country study targets
Develops country level patient recruitment strategy & risk mitigation. Coordinates and ensures country level study enrolment targets and timelines are met
Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/s
Assessment and set up the of vendors during study start up period (locally)
Investigator Meeting participation and preparation
Ensures data entered in Clinical Trial Managements Systems is current and complete and access to eDC and vendor systems is available for the Country and clinical trial site personnel
Validation of study related materials (i.e. protocol, ICF, patient material)
Responsible for preparing country specific documents (e.g. global country specific amendment)
Prepares materials for Site Initiation Visits
Responsible for verifying and confirming with local team eTMF completeness (Country and Site level)
Reviews Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues
Coordination of database locks and query follow up. Ensures timelines are met
Ensure inspection readiness of assigned trials within country. Provide support to Health Authority inspection and pre- inspection activities
Coordinates, develops and writes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings
Drives CAPA review, implementation and completion
Lead study team meetings locally
Reviewing and approving payments (based on GOA) and manage patient compensation claims (if applicable)
Management of Site relationships (includes CRO related issues)
May conduct Pre-Study Evaluation Visits (PSEVs) and Site Initiation Visits (SIVs)
May perform site closure activities, including post-close out
May act as point of contact for Sites
May support preparing submissions to and obtaining approval from local Health Authorities, Ethics Committees and other relevant instances
Responsible for the end-to-end management of budgeting and contracting for Study Teams with a focus on contracting a variety of contracts & study types including Confidential Disclosure Agreements (CDAs), Investigator contracts for BMS sponsored studies, non-registrational
Provide knowledgeable single-point of service to study teams related to study budgets and contracts
Prepare study /site level grant budgets
Manage the end-to-end process for executing Clinical Trial Agreements (CTAgs) with investigator sites
Prepares contract documents from templates and modify to reflect unique aspects of the particular study, including (the CTAg financial appendix)
Negotiates financial and legal aspects of CTAg and Master Service Agreements with sites, Institutions or vendor personnel
Is trained on legal fall back language and works with Legal as needed
Communicates clearly and efficiently with BMS Clinical and Legal Teams regarding amendments and other issues Enter CTAg, documents and data into Clinical Trial Management System and contract management software and ensure correct filing
Preparation, negotiation and execution of Master Agreements with Institution
Develop and maintain template language in collaboration with legal for all contract types. Would include maintenance of associated back-up language
Escalate to appropriate BMS colleague when a significant risk to the business is identified
Qualifications
Bachelor's degree required preferably within life sciences or equivalent
Experience - Responsibility and minimum number of years
Clinical Trial Manager: Minimum of 4 years' industry related experience
Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives
Competencies - knowledge, skills, abilities, other
Thorough understanding of GCP, ICH Guidelines and Country regulatory environment
In depth knowledge and understanding of clinical research processes, regulations and methodology
Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management
Software that must be used independently and without assistance
