Clinical Data Lead/Senior 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.

We have an incredible opportunity for an experienced Clinical Data Lead to join the team.

The role:
• As a member of staff, the employee is encouraged to accept and supply 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 and international
• Ensure all work performed is of high quality, aligned with Good Clinical Practice, ICH Guidelines and all applicable laws and regulations
• Independently prepare all materials and take part in study kick off (internal and external) meeting
• Read, ensure understanding and adhere to the study's 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 revenue recognition/forecasting process by performing the process monthly
• Ensure effective implementation of standard metric and status reporting on 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
• 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 critical issues
• Independently negotiate the time lines 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 detailed and the documentation filed in the DM Study files
• 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

You will need:
• US/LATAM/CAN: 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 leading all aspects of and coordinating tasks delegated to the study team members
• Experience of at least one of ICON preferred 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
• 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

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.