Clinical Data Lead

Clinical Data Lead

Location: UK and EU

KEY RESPONSIBILITIES:

• Record all billable and non-billable time in the appropriate timesheet management system (e.g. Planview™).
• Independently prepare all materials and take part in study kick off (internal and external) meeting.
• Read, ensure understanding and adhere to the study protocol, contract and scope of work for all task during set-up, maintenance and close-out of the study.
• Review all activity on an ongoing basis to identify out of scope tasks and bring to the attention of the DMPM and Contract analyst.
• Demonstrate an understanding of the revenue recognition and revenue forecasting process by independently performing revenue recognition and revenue forecasting process on a monthly basis.
• Lead the development of specifications, implementation, and testing for the eCRF or paper CRF.
• Lead the development of specifications, implementation, and testing for the edit checks and data review and oversight listings (DVS).
• Lead development of the data management plan and study specific procedures.
• Ensure effective implementation of standard metric and status reporting on the study.
• Lead development of specifications for custom reporting on the study.
• Independently perform project planning tasks and develop the project plan and timelines.
• Adhere to the project plan and timelines in the implementation of study tasks during set-up, maintenance and close-out of the study.
• Key point of contact for the sponsor and the study team on day-to-day study data issues, eCRF design, edit checks, and other implemented components.
• Independently attend and provide an update for data management services at cross- functional study team meeting both internally and with the sponsor.
• Maintain and track meeting minutes, issues and decisions logs, and escalations.
• Independently negotiate the timelines and make study level decisions.
• Provide regular study status updates to the DMPM.
• Support the DMPM in the delivery of study specific training to all team members, ensuring that the training is documented, and the documentation filed in the Data Management Study files.
• Assess the training needs of study team members on an ongoing basis.
• Provide refresher training to team members as required.
• Provide feedback to the DMPM on issues with study team member performance.
• Deliver training to cross-functional study team members both internal and external (e.g., training in the study specific electronic CRF for monitors or Site staff at the investigatory meeting).
• Represent Data Management at internal/external audits and manage findings through resolution both operationally and within the Quality Management System
• Participate in Business Development presentations to sponsor as required.

The position is a great opportunity to offer a Clinical Data Managers who enjoys problem solving, innovative, has a strong attention to detail and understands how to detect issues within complex projects.

• PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
• A minimum of 5 years clinical data management experience including 3 years' experience as a data management lead or point of contact for day-to-day activity on studies with key responsibilities for study set-up and close-out tasks as well as overseeing and coordinating tasks delegated to the study team members.
• EU/APAC: Prior relevant clinical research industry experience.
• Experience of at least Rave, Inform, Oracle Clinical, OCRDC, UX EDC