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 a Clinical Data Lead to join the team.

LOCATION OPTIONS

• United States (home-based OR office-based)
• Mexico (office-based with some remote flexibility)
• Canada (home-based OR office-based)

Summary:

As a Clinical Data Lead (CDL) 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. You will also co-ordinate 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

• Independently prepare all materials and take part in study kick off (internal and external) meeting.
• 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.
• Lead the development of specifications, implementation, and testing for the eCRF or paper CRF.
• Lead development of the data management plan and study specific procedures.
• 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.
• 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 negotiate the time lines and make study level decisions.
• 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.

To apply you will need

• 5+ years clinical data management experience including 3+ years 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 overseeing 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.