Principal Clinical Data Science Lead

hace 5 días

Bogotá, Bogotá D.E., Colombia ICON Plc A tiempo completo
Principal Data Science Lead (PCDSL - Early Phase Specialized) - Mexico & Colombia - Remote

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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, ensuring 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 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 relation 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.
- Bachelor's 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.

What ICON can offer you:

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits designed to be competitive within each country and focused on well-being and work-life balance opportunities for you and your family.

Our benefits examples include:

- Various annual leave entitlements.
- A range of health insurance offerings to suit you and your family's needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
- Life assurance.
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organization. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 or submit a request here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply.

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