Principal Clinical Data Science Lead

hace 6 meses

Bogota, Colombia ICON A tiempo completo

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

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

**LOCATIONS**:

- Mexico (office-based with remote flexibility)
- Colombia (office-based OR home-based)

**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
- CVs must be submitted in English

**BENEFITS OF WORKING IN ICON**:
Our success depends on the knowledge, capabilities, and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.

In addition, our best-in-class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

**ICON, including subsidiaries, 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.**

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