Sr. Clinical Trial Manager Consultant

Sr. Clinical Trial Manager (Sr. CTM) 

Responsibilities  

• 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. 

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

• 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. 

• 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. 

• 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. 

• 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. 

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

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

• As required, collaborate with external vendors, including CROs, central laboratories, and imaging providers, to ensure their efficient and effective deliverables to the trial. 

• Contribute to the development and review of study-related documents, such as protocols, informed consent forms, case report forms (CRFs), and standard operating procedures (SOPs). 

• Prepare study materials and establish procedures to ensure adherence to study protocols and administrative requirements. 

• Lead the creation and maintenance of all study files, including the study master file, and oversight of site files. 

• Lead periodic review of the Sponsor Trial Master File. 

• and other clinical study management activities as assigned by Eikon 

Qualifications 

• Bachelor's or advanced degree in a relevant scientific discipline 

• Minimum of 5 years of experience in Clinical Operations; Oncology trial management experience preferred 

• In-depth knowledge of clinical trial regulations, guidelines, and best Practices, including ICH-GCP and FDA requirements, specific to oncology research 

• Demonstrated experience in managing and executing clinical trials from start-up to closeout 

• Strong project management skills, with the ability to effectively prioritize tasks, allocate resources, and manage study timelines and budgets 

• Excellent interpersonal and communication skills, with the ability to collaborate effectively with stakeholders at all levels, and create a clear sense of direction as necessary 

• Detail oriented with strong analytical and problem-solving abilities, capable of identifying and mitigating study risks and deviations 

• Proficiency in using Veeva clinical trial management systems (CTMS) preferred 

• Understanding of oncology therapeutic areas, including familiarity with oncology treatment modalities, disease progression, and related medical terminology.