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In oncology, hematology, immunology, and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change.
We bring a human touch to every treatment we pioneer.
Join us and make a difference.
As Clinical Trial Manager, you will be responsible for study oversight and delivery management (time, budget, quality) at country level from start-up to closure.
You will serve as the main point of contact at a country level for internal and external stakeholders.
Key Responsibilities 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 setup of vendors during study start-up period (locally).
Investigator Meeting participation and preparation.
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, ensuring 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.
Leads study team meetings locally.
Reviews and approves 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.
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