Clinical Trial Activation Specialist
4 weeks ago
The Clinical Start-Up Trial Specialist will be responsible for driving and executing all start-up and maintenance-related activities and deliverables for assigned studies and sites in their assigned country or countries.
Key Responsibilities- Ensure the successful, on-time, and quality execution of start-up and maintenance activities for assigned sites and studies.
- Establish the country/site activation plans and priorities, including risk assessment and mitigation plans with CCOM/COM, Area SSU, and CSM Lead.
- Proactively identify and communicate issues impacting delivery and provide proposed solutions.
- Attend regional/area start-up calls and provide input for assigned sites/studies.
- Collect essential documents from sites and complete quality checks (ALCOA).
- Compile and submit ethics and other required local submissions, including customization of ICFs, patient-facing materials, and safety reporting.
- Coordinate with Regulatory and CTS on CA submission and approval status to ensure alignment with other site activation requirements.
- Collaborate with contract manager, CRA, and Area CSM Lead as required to ensure timely site activation.
- Review site and/or IRB/EC comments on ICFs and route for approval by required functional areas.
- Trigger clinical supply shipments.
- Complete IP release activities and trigger IP shipment.
- Issue site green light letter and activate sites in IXRS.
- Track all start-up and maintenance-related activities in Vault SSU as appropriate.
- Maintain local country and site intelligence database and EDLs in Vault.
- Maintain SSU performance metrics and KPIs for assigned sites/studies.
- Provide start-up updates and metrics to CCOM/COM and Area SSU and CSM Leads.
- Ensure audit/inspection readiness.
- Ensure compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines.
- Participate and drive process improvement initiatives as required.
- Degree in a health care or scientific field.
- A minimum of 3 years of clinical research experience and preferably 1+ years of study start-up management experience for the designated region.
- Experience in VEEVA VAULT or similar Clinical Trial Management System for project management.
- Exposure in site selection, feasibilities, and budget reviews.
- Experience working with remote/virtual teams.
- Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives.
- Strong interpersonal skills with the ability to build trust and communicate with clarity, flexibility, and adaptability to changing requirements.
- Demonstration of successful start-up and activation, and aptitude for managing multiple priorities in a fast-paced environment.
- Working knowledge of ICH and GCP guidelines and operational understanding of the country's regulatory environment.
Candidates meeting the criteria may apply via this portal or via www.mnarecruitment.com. If you do not receive feedback within 7 days, please consider your application unsuccessful.
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