Sr. Clinical Trial Manager (Sr. CTM)

Responsibilities

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- In partnership with Clinical Study Management, provide guidance and daily oversight for the successful in-house management of all aspects of international clinical trials, delivering high quality study data, on time and on budget.

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- Develop and execute operational plans for the successful in-house implementation and management of oncology clinical trials.

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- Collaborate with cross-functional teams, including data management, clinical scientists, regulatory and investigators, to ensure operational excellence and rapid delivery of high quality data. Ability to examine functional issues from a broader organizational perspective.

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- Manage all aspects of trial start-up activities, collaborating with other Clinical Operations functions (Site Engagement & Monitoring Excellence, and Supplier Relationship Management & Performance), to deliver efficient and effective site selection, feasibility assessments, and preparation of study-related documentation.

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- Collaborate with other Clinical Operations functions (Site Engagement & Monitoring Excellence) to efficiently and effectively deliver study site initiation, training, and monitoring activities to ensure adherence to study protocols, regulatory requirements, and ICH-GCP guidelines.

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- Collaborate with other Clinical Operations functions (Site Engagement & Monitoring Excellence) to develop and maintain strong relationships with investigators, study coordinators, and study site personnel to facilitate patient recruitment and retention.

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- Monitor and evaluate study progress, identifying risks, issues, and deviations, and implement appropriate corrective actions to maintain study integrity and timelines.

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- Ensure compliance with regulatory requirements, including ICH-GCP, FDA guidelines, and other applicable regulations throughout the trial lifecycle.

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- As required, collaborate with external vendors, including CROs, central laboratories, and imagin

📌 Sr. Clinical Trial Manager Consultant (Celaya)
🏢 ClinChoice
📍 Celaya