Clinical Data Science Lead (External Data)

Clinical Data Science Lead (External Data)

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.

This role is responsible for study level external-data management activities within a drug development program for QSEG. Not only to develop EDM responsible deliverables and to execute EDM responsible activities, this includes all aspects of broader DM deliverables to provide insights from EDM perspective especially for fundamental data management field  (external data spec/ingestion, eSource,  data standards, database build, etc.), and overall management/oversight of all external-data management activities with getting the picture progress/milestone for assigned projects to ensure that studies are executed within the agreed timelines and according to the agreed global standards and processes. The position has full accountability for the EDM deliverables across multiple studies and is responsible for oversight/taking control EDM vendor if outsourced EDM activities.

Responsibilities and Accountabilities:

• ​​Demonstrated knowledge and experience of all aspects of the Data Management (DM) discipline. Ability to support multiple studies concurrently with minimal oversight by functional manager.
• Advocates the EDM position within study team meetings and/or study QSEG internal communications.
• May act as a functional DM expert for a specific EDM specialty area, such as data standards, eSource, listings, etc.
• Support Data Reporting & Analytics team to develop e-data related listings with well understanding requirements of study protocol basis and ensure effective/qualified listings to release in production.
• Communicates/Oversees multiple External vendors (Lab vendor, IRT vendor, etc.) to progress e-data cleaning in timely manner.
• Supports development and execution of eDM reviews and plans across study teams, including KRIs.
• Oversees/ EDM vendor staff supporting EDM work if applicable, and provides suggestion/indication/training if needed.
• Proactively shares and provides suggestions on how to improve Astellas processes, how to improve vendor oversight with functional manager and/or EDM team. Uses metrics and key performance indicators (KPIs) to monitor performance on studies regardless of vendor performance or one’s own performance.
• Documents any process related deviations and communicates to functional manager.
• Coordinates, facilitates and leads the e-data discrepancy meetings for all external data sources with Medical, Clinical Operations, LDM, Biostatistics, Stat Programming, and eCOA Lead (if applicable) etc to highlight and discuss external data issues in any risks, and ensure e-data readiness for use.
• knowledge of regulatory requirements, such as GCP, and how they impact Data Management activities and outputs.
• Collaborates with other functions to promote consistency in the management and conduct of eData management to enhance edata quality and operational workflows.

Required Qualifications:

• ​​Bachelor’s degree in biological science, health-related or computer science field (or equivalent experience).
• Typically 6+ years of relevant experience in pharmaceutical, clinical research, or health services industry with at least 4 years as a Data Manager, showing increasing responsibility across study types and phases.
• Demonstrated strength and developing subject matter expertise in Data Management (DM).
• Subject matter expertise for key DM related global process improvement initiatives.
• Prior exposure to regulatory submission, inspection and major (vendor) audit experience preferred.
• Well-versed knowledge of data management, stats programming, biostatistics and clinical operations.
• Strong computer skills in database management software, and reporting tools.
• Familiarity with eSource systems/devices and diverse clinical trial data sources.
• Working knowledge of statistical programming, biostatistics, and clinical operations.
• In-depth knowledge of drug development strategy, clinical trial, and data management processes.
• Proven ability to think critically to enable judgement-based decisions related to data management.
• Solid knowledge of clinical data standards (e.g., CDASH/CDISC) and international clinical trial regulations (e.g., GCP).
• Proven ability to think critically and exercise judgement-based decisions in DM activities.
• Strong communication skills with ability to build effective cross-functional relationships and various external/global vendors.
• Demonstrated learning agility and openness to adopting new data management technologies and practices not only from strategic/operational level but also logical/programmatic level.

Preferred Qualifications:

• ​​SCDM Certified Clinical Data Manager (CCDM) preferred.
• Experience with RAVE, and eClinical Solutions elluminate is a plus. Program with SAS and SQL is a plus as well.

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. Our benefits are designed to be competitive within each country and are 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, LifeWorks, 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.

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.

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