Clinical Trial Manager I Resume Example

providing services for Bristol Myers Squibb.

• Responsible for study oversight and delivery management (time, budget, quality) at country level from start-up to closure. Serves as the main point of contact at a country level for internal and external stakeholders.
• Recognize, exemplify and adhere to the ICON/DOCS values which center around our commitment to People, Clients and performance.
• 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 stakeholders
• Assessment and set up the of vendors during study start-up period (locally)
• Investigator Meeting participation and preparation (may include travel)
• Ensures data entered in Clinical Trial Management 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.
• Ensures 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)
• Conduct Pre-Study Evaluation Visits (PSEVs) and Site Initiation Visits (SIVs)
• Perform site closure activities, including post close-out
• Act as point of contact for Sites
• Support preparing submissions to and obtaining approval from local Health Authorities, Ethics Committees and other relevant instances.
• Maintain client, ICON/DOCS and patient confidentiality.
• Mentor and train new staff, as assigned
• Other duties as assigned.