Clinical Data Lead

The lead data management 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, reporting to the Data Management Project Manager.

Job Responsibilities

Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance

As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs

Travel approximately 10% domestic/international

Read, ensure understanding and adhere to all assigned ICON SOPs and working procedures

Ensure all work performed is of high quality, compliant with Good Clinical Practice, ICH Guidelines and all applicable laws and regulations

Complete all assigned training (including the Study Lead Development Program) and courses in the ICON Training Management system (iLearn); ensuring that mandatory courses are all completed before the designated date and that the required system specific training has been completed for current studies

Record all billable and non-billable time in the appropriate timesheet management system (e.g. PlanviewTM)

Take part in study kick off (internal and external) meeting along with the DMPM

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

Assist in compiling the change order log for review by the DMPM

Develop an understanding of the revenue recognition and revenue forecasting process

Assist the DMPM with 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

Perform project planning tasks and support the DMPM in the development of 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 SOPs, the Data Management Plan and study specific procedures in the implementation of tasks on the study

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

Organize and lead regular data management team meetings, both internal and with the sponsor and the DMPM

Attend and provide an update for data management services at cross-functional study team meeting both internally and with the sponsor and the DMPM

Maintain and track meeting minutes, issues and decisions logs, and escalations

Support the DMPM in negotiation of time lines and decision making on the study

Provide regular study status update 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

Support the DMPM in the delivery of 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)

Job Requirements:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

US/LATAM/CAN: A minimum of 3 years clinical data management experience.

EU/APAC: Prior relevant clinical research industry experience.

Experience of at least one of ICON preferred CDMS (Rave, Inform, Oracle Clincal, OCRDC)

Highly computer literate, including strong Microsoft Office skills (Excel, Word, Powerpoint, Project)

Excellent communication and interpersonal skills, both verbal and written skills

Strong client relationship management skills, and the aptitude to develop this further

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

Education:

Bachelor's degree or local equivalent in a scientific discipline and/or appropriate experience