Senior Clinical Data Coordinator

Under the direction of the Sponsor Clinical Data Management (CDM) Lead, the Senior CDC performs tasks to support the clinical trial data management life-cycle from study start-up through database lock and study close-out. Under the direction of the CDM Lead, the Associate Manager Clinical Data Management contributes to the successful conduct of Takeda’s clinical trials and to the delivery of high quality and timely data, which are used in statistical analysis and then submitted to regulatory authorities for the approval of Sponsor products

Key Accountabilities

Under the direction of the CDM Lead or delegate, performs data management tasks according to applicable SOPs (standard operating procedures) and processes. These activities may include the following categories:

Data Review

• May perform one of more of the following:
• Performs data review of clinical trial data, including query management. Communicates with study team members and CRO (Contract Research Organization) to resolve queries.
• Performs detailed review of eCOA/external data per the Date Review Plan and works closely with the vendor and CRO to resolve eCOA/external data related issues. May include the following:
• Acts as liaison between Sponsor, CRO and eCOA vendor/external data vendor.
• Ensures accessibility of eCOA/external data to all relevant Sponsor and CRO team.
• QCs a sample of data clarification requests processed by the eCOA/external data vendor.
• Maintains eCOA/external data issues within the centralized study data issues log.
• Ensures appropriate and timely communication of eCOA/external data related issues and resolutions to relevant Sponsor and CRO team.
• Performs reconciliation review of eCOA/external data against EDC data and works with applicable parties to resolve queries.
• Performs SAE (Serious Adverse Event) reconciliation and communicates with applicable safety team members to resolve issues.
• May prepare and distribute performance metrics (e.g. site completion of data entry and resolution of queries) to applicable stakeholders. Escalates to CDM Lead and study team as needed.
• Contributes to the creation and maintenance of study data cleaning plan components, including edit checks (data validation plan), listing review checks, data integration specifications, data transfer specifications, external data reconciliation plan(s), coding guidelines, SAE reconciliation guidelines, database lock plans.
• Performs additional review activities for interim and final database locks as needed.

Documentation & Filing

• Files study documentation in electronic Trial Master File (eTMF) and department project files.
• Performs periodic quality review of eTMF documents.
• Assists with taking meeting minutes and documenting/tracking study data management activities.
• Performs data archival activities.
• Performs inspection readiness activities and supports CDM team during internal and regulatory inspections

Data Collection Systems

• Supports the set-up and testing of study data collection tools such as EDC (electronic data capture), IRT (interactive response technology), eCOA (electronic clinical outcome assessment), ePRO (electronic patient reported outcomes), and creation/maintenance of associated documentation.
• May contribute to the creation and maintenance of study eCRF Completion Guidelines and other data collection tool guidelines.
• May assist with management of account access and training materials for data collection tools

Additional Activities

• Assists with quality review of above activities performed by the CRO, as needed.
• Coordinates and oversees the work of other data coordinators.
• Mentors other data coordinators.
• Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
• Performs other duties as assigned.

Educational Qualifications

Associate or Bachelor's Degree preferred

Experience

• Understanding of clinical trial documents (protocols, case report forms, data management plans, study
• reports) and processes
• 2-5 years relevant work experience, or equivalent combination of training and experience.
• Experience in data management/drug development within GCP/clinical research regulatory environment.
• Experience with electronic data collection systems.
• Experience managing multiple work deliverables and deadlines.
• Knowledge of data management best practices & technologies as applied to clinical trials.
• Knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.

Special Skills/Abilities

• Strong attention to detail, and organizational skills
• Good time management skills
• Quick learner and comfortable learning new technologies and systems
• Advanced knowledge of office software (Microsoft Office).
• Demonstrated good communication and project management skills.