Principal Clinical Data Science Lead
ICON plc
full-time
Posted on:
Location Type: Remote
Location: United Kingdom
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Job Level
Tech Stack
About the role
- Provide leadership with CROs, clinical study teams, and internal and external stakeholders to align and maintain data management expectations for assigned clinical trials
- Define quality standards and timelines for data management deliverables and actively track milestones
- Ensure compliance with standard operating procedures, company policies, and regulatory requirements from study start up through close out
- Support CRO selection and contract negotiations in collaboration with the clinical study team and Vendor Management
- Contribute to protocol development and review for data management related sections, including feasibility of data collection and data lock strategy
- Oversee all outsourced data management deliverables in line with the Statement of Work and Trial Oversight Plan, including data collection tools, essential documentation, submission ready datasets, and archival packages
- Ensure timely completion and cross functional review of data management documentation and deliverables
- Track project plans, budgets, metrics, and key performance indicators, adjusting plans as required with CRO and clinical partners
- Develop and oversee Data Release Plans, including interim and final data locks and DSMB or IDMC data releases, in line with blinding requirements
- Participate in User Acceptance Testing and perform quality control to ensure data completeness and accuracy
- Capture lessons learned and share best practices across the study team and department
- Lead or contribute to process improvement initiatives
- Participate in regulatory inspections and audits
Requirements
- Knowledgeable in GCP standards, CDISC standards.
- Experience with tools and systems for managing clinical studies (study progress and metric systems, eCRF systems, metadata repositories)
- Eye for detail, analytical skills
- Able to work effectively within a team matrix as well as independently
- Strong communication and interpersonal skills
- Bachelor’s or Master’s Degree (Biology, Biomedical Sciences, Pharmacy, Mathematics, etc.) or equivalent experience; 8+ years within Data Management
- Demonstrated experience in Clinical Data Management
- Experience in managing CROs and vendors.
Benefits
- 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 specialised 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, subsidised travel passes, health assessments, among others.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
data managementclinical data managementprotocol developmentquality controldata lock strategyproject planningbudget managementkey performance indicatorsprocess improvementUser Acceptance Testing
Soft skills
leadershipanalytical skillscommunication skillsinterpersonal skillsattention to detailteam collaborationindependenceproblem-solving
Certifications
Bachelor’s DegreeMaster’s DegreeGCP certificationCDISC certification