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.
Qualifications
Clinical Trial Manager Minimum of 4 years' industry related experience
Senior Clinical Trial Manager At least 6 years of industry related experience
Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiative
