• Responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects • Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s) • Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing • May perform quality control of data entry • Provide input, assess and manage timelines • May develop CRF specifications from the clinical study protocol • Conduct database build UAT and maintain quality controlled database build documentation • Responsible for creating, revising, appropriate versioning and maintaining data management documentation • Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed • Review and query clinical trial data according to the Data Management Plan • Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM • Run patient and study level status and metric reporting • Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency • Coordinate SAE/AE reconciliation • Liaise with third-party vendors such as external data and EDC vendors • Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies • Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities • Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues

• The Clinical Data Manager II/Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. • Supervise project data entry process including development of data entry guidelines, training, data entry quality, and resourcing. • Ensure clinical data management deadlines are met with quality. • Conduct database build UAT and maintain quality controlled database build documentation. • Provide input, assess and manage timelines. • Review and query clinical trial data according to the Data Management Plan. • Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.

• Responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. • Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. • Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing • Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. • Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database. • Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File. • Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed. • Review and query clinical trial data according to the Data Management Plan. • Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM. • Liaises with third-party vendors such as external data and EDC vendors in a project manager capacity in support of timelines and data-related deliverables. • Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.

• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs. • Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing • May perform quality control of data entry • Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed. • May develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders • Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database. • May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications • Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File. • Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed. • Review and query clinical trial data according to the Data Management Plan • Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM • Run patient and study level status and metric reporting • Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency • Coordinate SAE/AE reconciliation • Liaises with third-party vendors such as external data and EDC vendors in a project manager capacity in support of timelines and data-related deliverables • May assist with SAS programming and quality control of SAS programs used in the Data Management department • Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders • May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project • Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities • May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings • May review Request for Proposals (RFP), proposals, provide project estimates • Provide leadership for cross-functional and organization-wide initiatives, where applicable • Trains and ensures that all data management project team members have been sufficiently trained • Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues • May present software demonstrations/trainings, department/company training sessions, present at project meetings • May require some travel • Perform other duties as assigned