Clinical Data Lead

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

**Clinical Data Lead**

**_ *Role is South African based - remote working or office based*_**

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.
- 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.
- Coordinate with data management teams, studies and programs of studies and independently oversee the performance of data management activities on multiple studies.
- Reporting to the Project Manager I Sr. Project Manager, Data Management.

**Overview of the Role**
- 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 I international.
- Read, ensure understanding and adhere to all assigned ICON/Client 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 COL 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. Planview).
- Independently prepare all materials and take part in study kick off (internal and external) meeting.
- Read, ensure understand ing 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.
- Independently compile the change order log and distribute internally as per ICON's change order process.
- 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.
- 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.
- 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 time lines and make study level decisions.
- Provide regular study status updates to the DMPM.
- Support the DMPM in the d