Principal Clinical Data Science Lead

Principal Clinical Data Science Lead- Early Phase

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

We have an incredible opportunity for a Principal Clinical Data Science Lead to join ICON.

OVERVIEW OF THE ROLE:

This Principal Clinical Data Science Lead (CDSL) role is part of the Early Phase Data Management department and is responsible for managing data management teams, studies, and programs of studies under the general direction of the Senior Manager/Director of Data Management. The Principal CDSL will provide planning estimates for project scope, schedule, and resource requirements, and ensures that studies are properly managed and delivered. They will work with Clinical Operations, Biostatistics, SAS Programming, Medical Writing, and Quality Assurance to ensure that data collected during trials is managed according to corporate standards and meets regulatory guidelines for data integrity.

The Early Phase service line of the company specializes in the strategic development, management, and analysis of studies and programs that support Phase 1/2a clinical development.

The Principal CDSL will manage a number of fast-moving early phase studies or programs of studies to ensure project objectives are met within budget, to agreed timelines, and to a high level of quality. As a Principal CDSL, you will manage a global team of clinical data management resources. The Principal CDSL will provide input into CRF design, protocol review, edit check specifications, data entry conventions, monitoring guidelines, and any other study related documents and will be responsible for the maintenance, cleaning, and lock of the EDC study databases.

Additional Responsibilities:

Review the project contract in order to ensure that any out-of-scope work is managed promptly and efficiently

Manage the overall project budget throughout the life cycle of the project, taking overall responsibility for cost control, timelines, and project quality

Negotiate with clients and/or external customers/departments in relations to timelines and key deliverables

Travel (approximately 15%) domestic and/or international.

TO BE SUCCESSFUL, YOU WILL NEED:

6+ years of clinical data management experience (in a Clinical Research Organization or Pharmaceutical company)

3+ years of experience leading studies with key responsibilities for study set-up and close-out tasks

Experience with Phase I studies strongly preferred, but not required

Experience with Rave strongly preferred, but must have experience with at least one of ICON’s preferred CDMS (e.g. Rave, Inform, Oracle Clinical, OCRDC, UX EDC)

Highly computer literate, including strong Microsoft Office skills

Excellent communication and interpersonal skills

Strong client relationship management skills

Excellent organizational and planning skills as well as a demonstrated aptitude for project management

Bachelors degree or local equivalent in a scientific field and/or equivalent experience

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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

Competitive base salary and performance related incentives

Health and wellbeing programmes including medical, dental, and vision coverage where applicable

Retirement and pension plans

Life assurance and disability coverage

Employee assistance programmes and wellbeing resources

Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to about the benefits ICON offers.

Inclusion and Accessibility

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.