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Senior Clinical Data Lead

Employer
ICON Plc
Location
India
Salary
Competitive
Start date
9 Nov 2023
Closing date
9 Dec 2023

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Job Details

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.

Job roles & 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 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.
• lnde endentl or anize and lead re ular data mana ement team meetin s, both internal and with the
HR006-SOP-F01Nersion 1.0/Effective: 10 February 2015 (Ref. HR006-SOP) Page 2 of 5

A Symbol of Excellence

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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