Overview
Clinical Research Manager (CRM) to lead and manage the end-to-end performance of assigned clinical trial protocols within a designated country. This role ensures compliance with ICH/GCP guidelines, country regulations, and company policies and procedures.
Responsibilities
* Act as the primary contact for assigned protocols, coordinating efforts between Country Operations and the Clinical Trial Team (CTT).
* Manage project timelines and performance metrics, ensuring all country commitments are met.
* Review Monitoring Visit Reports, escalating issues and training compliance to managers as necessary.
* Lead local study teams, providing training and support on protocols to enhance performance.
* Create and execute local risk management plans for assigned studies.
* Ensure compliance with CTMS, eTMF, and other essential systems.
* Collaborate with outsourcing vendors, investigators, internal stakeholders and external partners to facilitate study success.
* Build and maintain business relationships with investigators and support local business needs.
Qualifications
* Bachelor's degree in Science or related field with 5+ years of clinical research experience.
* Experience as a Clinical Research Associate (CRA) or Clinical Research Manager (CRM).
* Strong organizational skills and ability to make independent decisions.
* In-depth understanding of local regulatory environment and clinical trial management.
* Effective communication skills and ability to work collaboratively in a remote/virtual environment.
* Proficiency in written and spoken English and local language.
* Proven project management skills or relevant certification/training.
Nice to have
* Advanced degree (e.g., Master\'s degree, PhD).
Additional Information
Job Posting End Date: 09/03/2025. Requisition ID: R362410. Employment type: Full-time. Travel: Hybrid. Company relocation and visa sponsorship details are as per policy. We are committed to flexible working where possible and have introduced a hybrid working model for office-based colleagues around the world.
As an equal opportunity employer, we are committed to diversity and inclusion. If you need support during the recruitment process, contact the Talent Acquisition Advisor assigned to this role.
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