Clinical Data Specialist jobs in Middlesex, NJ

Job Title: Clinical Data Manager

Location: Remote

Job Description:

The Clinical Data Manager is 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.

Essential Duties and Responsibilities:

• May be designated Lead Data Manager on assigned study, working under oversight of Data Management Team Lead or other Senior Data Manager.
• Either as the Lead Data Manager, or assisting designated Lead Data Manager, drive all assigned study data management activities, from study startup through closeout in accordance with SOPs.
• Draft & final protocol review, study specification creation, case report form design, database design/build, form and edit check programming within EDC, and review of all data management specific study documents.
• Implementation of all data cleaning processes, discrepancy resolution, data transfer/control activities, and validation.
• Proactively and independently manages data management activities on assigned studies, including but not limited to setting and management of timelines, milestone deliverables, etc.
• Lead and/or coordinate the user acceptance testing through the build phase of the EDC platform to ensure completeness and correctness.
• Develop and implement the Data Management Plan which outlines the end-to-end handling of the data correction process, discrepancy resolution, data control activities, and data validation.
• Direct clinical trial studies from the initial preparation through database closeout, including all necessary regulatory submissions by standardizing study data in compliance with established guidelines.
• Ensure all Data Management study documentation and management of clinical study data is in accordance with ICH/GCP, SOPs, and regulations.
• Proactively coordinate and perform start-up, processing, and finalization activities as detailed in Lotus SOPs and the Data Management Plan.
• Proactively drive/support departmental process improvement efforts to include regular SOP, work instruction, and master document review/update.
• Assist other Clinical Data Managers with delivery of data management activities on an ad hoc basis.
• Ensure documentation and management of clinical study data is in accordance with regulations.
• Proactively coordinate and perform start-up, conduct, and closeout activities as detailed within SOPs.
• Ensure the project quality through direct supervision and Quality Control of team members’ work. Provide feedback as needed to team members to ensure the submitted work meets sponsor expectations.
• Participate as needed in reviewing and responding to QA audit reports.
• Actively participate in appropriate sponsor/project team meetings to provide clear and concise information as to how the study is progressing from a Data Management perspective including clearly articulating any issues or patterns observed throughout the study.
• Proactively manage timelines and projections.
• Proactively manages project quality through supervision and Quality Control of assigned team members’ work.
• Participate in reviewing and responding to QA audit reports.
• Proactively participate in appropriate sponsor/project team meetings.
• Leads and/or participate in User Acceptance Testing for projects as needed.
• Active involvement in departmental and organizational meetings and initiatives.
• Lead or assist with development and documentation of department procedures.
• Lead or participate in the review of cross functional department procedures.
• Train and mentor newer team members in accordance with the established departmental procedures and SOPs.
• Communicate with cross functional groups throughout the project lifecycle. Monitor project scope.
• Maintain key vendor relationships such as EDC System Vendor, etc.
• Perform other miscellaneous related duties, as required.

Education and/or Experience:

• MS/MA in health science, life science, information technology, or nursing AND 5 years equivalent experience OR demonstrated aptitude for the Clinical Data Manager role.
• Experience working in CRO industry preferred.
• Working knowledge of EDC studies.

Skills and Abilities:

• Excellent organizational skills.
• Strong written and verbal communication skills.
• 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.