Principal Clinical Data Science Lead
Role details
Job location
Tech stack
Job description
The Clinical Data Manager (CDM) is responsible for all data management aspects of the assigned clinical studies from initiation till closure ensuring that clinical data completeness, accuracy and consistency meet the standards of quality for analysis and reporting to regulatory bodies, compliant with the local and global regulations. What You Will Be Doing:
- 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
Trial Responsibilities For assigned trials, the Clinical Data Manager will:
- 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
Additional Responsibilities
- Lead or contribute to process improvement initiatives
- Participate in regulatory inspections and audits
Requirements
Do you have a Master's degree?, * 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.
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Benefits & conditions
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, 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.
