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.