Senior Clinical Trial Manager

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Position summary

Accountable for end-to-end study operational oversight and delivery at country level, ensuring adherence to timelines, budget and quality standards.

Acts as the primary point of contact at a country level for both internal and external stakeholders, ensuring clear communication, effective coordination, and successful project execution.

Position Responsibilities:

• Oversees and collaborates with study team members and cross-functional stakeholders, to proactively identify opportunities and manage and mitigate risks and to ensure timely and on-budget execution of clinical trial deliverables.
• Supports internal audit and inspection activities and contributes to corrective and preventive actions (CAPAs), including leading the resolution of issues when appropriate.
• Monitors updates throughout a study’s lifecycle for compliance with regulations and standard operating procedures (SOPs), including contract research associate (CRA) compliance with study parameters and tracks escalation and closure of action items noted in monitoring visit reports during late phase studies including registration of protocols.
• Monitors progress of clinical trials and identifies and resolves any issues or risks that may impact timelines or study outcomes.
• Serves as the key operational contact for clinical studies, providing oversight for the site evaluation, initiation and close-out visits in addition to routine monitoring visits.
• Participates in contract research organization (CRO) and vendor selection and manages all interactions and deliverables from relevant CROs and vendors under the guidance of leadership.
• Acts as the main point of contact for a country with global study team members and accountable for the coordination with local country  cross functional teams.
• Implements the local country and site feasibility process, including proposal and validation of country study targets, as endorsed by country leadership.
• Plans, develops and executes timelines and activities for start-up in collaboration with the local study team, Global Trial Acceleration Centre (GTAC) and other relevant stakeholders.
• Implement country and site level patient recruitment strategy and risk mitigation.  Coordinates and ensures country level study enrolment targets and timelines are met in collaboration with relevant stakeholders.
• 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 the Clinical Trial Management System (CTMS) is current and complete, and access to eDC and vendor systems is available for the country and clinical trial site personnel. This includes entering necessary data and uploading documents in eTMF.
• Validation of study related materials (i.e. protocol, ICF, patient material).
• Supports the review of country and site-specific documents (e.g. ICF, patient material), and where applicable may include the preparation of site level ICF and other documents.
• May support preparation of materials for Site Initiation Visits.
• Responsible for verifying and confirming with local team eTMF completeness (Country and Site level).
• Prepare investigator sites to conduct clinical trials through verifying acceptability of Clinical Trial Package (CTP) documentation.
• Acknowledges 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.
• En