Evolution Research Group
CRO-Senior Clinical Data Manager (Sr. CDM)
Evolution Research Group, New Providence, New Jersey, us, 07974
Senior Clinical Data Manager (Sr. CDM) – CRO
The Senior Clinical Data Manager manages the general conduct of project assigned tasks as the Lead Data Manager or under advisement from senior members of the Data Management Team. Responsible for oversight and conducting data activities in an efficient manner and in accordance with all SOPs and regulations. Responsibilities include all data management activities, customer relationship management, development and implementation of the data correction process, discrepancy resolution, data control activities, and data validation. In addition to these standard clinical data management responsibilities, the Senior Clinical Data Manager will also assist the management team with SOP review & update, process improvement, employee onboarding, and training. Serve as Lead for assigned studies, overseeing data management from startup to closeout per SOPs. Manage protocol review, study specs, CRF and database design, edit checks, and data validation. Lead data cleaning, discrepancy resolution, and data transfer/control activities. Develop and execute Data Management Plans and ensure compliance with ICH/GCP, SOPs, and regulatory standards. Coordinate and conduct User Acceptance Testing for EDC systems. Oversee clinical trial data from setup through database lock, including regulatory submissions. Monitor timelines, milestones, and ensure quality through supervision and QC of team deliverables. Support process improvements and SOP updates. Collaborate with cross-functional teams and maintain vendor relationships. Participate as needed in reviewing and responding to QA audit reports. Participate in audits, sponsor meetings, and departmental initiatives. Train and mentor junior staff; assist other Data Managers as needed. Perform additional duties as required. Education and/or Experience: BS/BA in health science, life science, information technology, or nursing preferred but not required with 6+ years of experience in clinical research and a demonstrated aptitude for the Senior Clinical Data Manager role. Experience working in CRO industry strongly preferred. Working knowledge of EDC systems, Medidata Rave and Veeva preferred. Thorough knowledge of ICH guidelines, GCP, and the clinical trial process. Skills and Abilities: Excellent organizational skills; strong written and verbal communication; exceptional attention to detail; technology proficiency including Data Management Systems; study documentation production and maintenance, data processing, data review; knowledge of clinical research including regulatory requirement GCP/ICH Data Quality; strong interpersonal skills; strong computer skills, including Microsoft Office.
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The Senior Clinical Data Manager manages the general conduct of project assigned tasks as the Lead Data Manager or under advisement from senior members of the Data Management Team. Responsible for oversight and conducting data activities in an efficient manner and in accordance with all SOPs and regulations. Responsibilities include all data management activities, customer relationship management, development and implementation of the data correction process, discrepancy resolution, data control activities, and data validation. In addition to these standard clinical data management responsibilities, the Senior Clinical Data Manager will also assist the management team with SOP review & update, process improvement, employee onboarding, and training. Serve as Lead for assigned studies, overseeing data management from startup to closeout per SOPs. Manage protocol review, study specs, CRF and database design, edit checks, and data validation. Lead data cleaning, discrepancy resolution, and data transfer/control activities. Develop and execute Data Management Plans and ensure compliance with ICH/GCP, SOPs, and regulatory standards. Coordinate and conduct User Acceptance Testing for EDC systems. Oversee clinical trial data from setup through database lock, including regulatory submissions. Monitor timelines, milestones, and ensure quality through supervision and QC of team deliverables. Support process improvements and SOP updates. Collaborate with cross-functional teams and maintain vendor relationships. Participate as needed in reviewing and responding to QA audit reports. Participate in audits, sponsor meetings, and departmental initiatives. Train and mentor junior staff; assist other Data Managers as needed. Perform additional duties as required. Education and/or Experience: BS/BA in health science, life science, information technology, or nursing preferred but not required with 6+ years of experience in clinical research and a demonstrated aptitude for the Senior Clinical Data Manager role. Experience working in CRO industry strongly preferred. Working knowledge of EDC systems, Medidata Rave and Veeva preferred. Thorough knowledge of ICH guidelines, GCP, and the clinical trial process. Skills and Abilities: Excellent organizational skills; strong written and verbal communication; exceptional attention to detail; technology proficiency including Data Management Systems; study documentation production and maintenance, data processing, data review; knowledge of clinical research including regulatory requirement GCP/ICH Data Quality; strong interpersonal skills; strong computer skills, including Microsoft Office.
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