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Clinical Data Lead

Dublin
Permanent
Reference: 061062_1571465213
Description

CLINICAL DATA ASSOCIATE

Locations: Ireland, UK, Poland, Madrid, Paris or Strasbourg

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries! You will be the point of contact for day to day activity on a study with key responsibilities for study set-up and close-out tasks as well as overseeing and coordinating tasks delegated to the study team members both locally and in other offices.

Additionally you will coordinate with data management teams, studies and programs of studies and independently oversee the performance of data management activities on multiple studies.

OVERVIEW OF THE ROLE

  • Record all billable and non-billable time in the appropriate timesheet management system

  • Independently prepare all materials and take part in study kick off (internal and external) meeting.

  • 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.

  • Independently compile the change order log and distribute internally as per ICON's change order process.

  • Lead the development of specifications, implementation, and testing for the eCRF or paper CRF.

  • Independently perform project planning tasks and develop the project plan and timelines.

  • Set up and maintain data management study files for inclusion in the Trial Master File, ensuring these are maintained in an audit ready state for review by Sponsor, Regulatory or ICON Auditors.

  • Adhere to ICON/Client SOPs, the Data Management Plan, Working procedures and study specific procedures in the implementation of tasks on 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.

  • 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.

  • 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.

ROLE REQUIREMENTS

  • Prior relevant clinical research industry experience, ideally with experience of at least one of CDMS (e.g. Rave, Inform, Oracle Clinical, OCRDC, UX EDC)

  • Highly computer-literate, including strong Microsoft Office skills (Excel, Word, PowerPoint, Project).

  • Excellent communication and interpersonal skills, both verbal and written skills, with a strong client relationship management skills and the aptitude to develop this further.

  • Excellent organizational and planning skills as well as a proven aptitude for project management, and the ability to lead more than one project and prioritize accordingly.

 

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