Clinical Trial Manager Consultant - II
Clinical Trial Manager 2 (CTM 2)
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 3 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.
About the job
Apply for this position
Clinical Trial Manager Consultant - II
Clinical Trial Manager 2 (CTM 2)
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 3 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.