Clinical Data Science Lead

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

As a Clinical Data Science Lead at ICON, you will drive data science initiatives within clinical trials, ensuring that our analyses provide meaningful insights that inform strategic decisions.

What You Will Do:

You will manage day-to-day clinical data science activities, supporting your team to deliver quality outcomes.
 

* Participates in study level vendor oversight activities. May represents data management function on the Clinical Sub-team ensuring aligned expectations.
especially in support of key decision points and regulatory submissions. 
* Serves as a first point of contact for CROs partners when collaboration is needed to ensure established milestones and deliverables are met with the highest degree of quality.
* Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks.
* Leads and manages clinical trial data collection set-up, data review, and database lock:
 (a) Works with other functions to complete set up of EDC and other study data collection tools such as IRT, 
ePRO and eCOA.
 (b) Leads the creation and maintenance of study data cleaning plan components, including edit checks (data validation plan), listing review checks, data integration specifications, data transfer specifications, external data reconciliation plan(s), coding guidelines, SAE reconciliation guidelines, database lock plans.
 (c) Leads data review, including query management, and leads activities required for interim and final 
database locks.
* Participates in preparing function for submission readiness and may represent function in a formal inspection or audit.
* Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
* Tracks study deliverables and evaluates study metrics to mitigate risk for major data management deliverables and milestones.
* Responsible for the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting.
* May prepare metrics to support the function’s KPIs.
* Contributes to functional Continuous Improvement initiatives, providing expertise and ensuring deliverables are provided on time, to budget, and in alignment with company, departmental or functional requirements.
* Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables 
* Champions and adopts technology improvements and tools for use in clinical data management processes.
 

Your Profile:

You will have solid clinical data science experience, with the ability to manage competing priorities and develop your team.

Required qualifications and experience:

*Bachelor's degree in life sciences, computer science, or a related discipline

* Preferred 4 + years experience in data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.
* Proven track record of strong project management skills and experience managing data management activities for large drug development programs.
* NDA/CTD Experience preferred.
* Strong knowledge of data management best practices & technologies as applied to clinical trials.
* Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
* Strong knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
* Good understanding of CDISC standards. Some experience in standards development, implementation and 
maintenance is ideal.
* Advanced knowledge of office software (Microsoft Office).
* Strong knowledge of relational databases and experience using multiple clinical data management systems.
* Good working knowledge of general medical coding in the pharmaceutical/biotechnology industry including 
knowledge of medical dictionaries, coding tools, and coding governance models.

#LI-JC3

#LI-Remote

What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   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.

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