Principal Biostatistician
ICON plc
Senior Clinical Trial Manager
ICON plc
full-time
Posted on:
Location Type: Hybrid
Location: Reading • 🇬🇧 United Kingdom
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Act as Delegate when assigned on a study.
- Authoring of Quality & Risk Management Plan
- Facilitate - Identification and documentation of CtQ
- Facilitate - Identification and documentation of critical data and processes
- Facilitation of the initial risk assessment process and meetings
- Ensuring on time and high-quality risk assessment completion
- Review critical data path /data flow in association with Clinical data science lead
- Review of critical data review methods in association with Clinical data risk analyst who is the author and owner of Data Review Requirements.
- Input and review of Risk based monitoring strategy- T-SDV/T-SDR, reduced SDV/SDR in collaboration with CTM
- Review/input into QTLs
- Review/input into central monitoring Key risk indicators
- Quality Gate - Review/input into all applicable Functional plans to ensure risk mitigations are appropriately covered.
- Initiate ongoing risk reviews
- Initiate Risk Review Meetings - QRRM
- Quarterly- Operational Quality review checks to ensure- Ø Ongoing Risk Review and ensure Risk & Risk control review are documented Ø Risk Review Meetings are conducted as planned- with proactive and fully engaged functional leads and sponsor when applicable.
- Review QRRM slides to identify the adequacy of content in RRM slides.
- Ø Monitoring strategy is operationalized as per plan and in alignment with budget
- Periodic Project Risk assessments as required by changes to critical data or risks or change in milestone or protocol amendments
- Input into division or program-level oversight, quality and compliance processes related to RBQM requirements.
- Ø study level reviews of quality related data, to identify trends and potential risks, including: Project non-conformance trending CAPA trending (project and site level CAPAs) Critical and Major audit & inspection findings (study and site level)
- Present review output to PM and FTLs, collaborating with them on the identification of risks, proposing potential risk mitigations and actions
- Report to Governance and oversight dashboard as per plan
- Serves as a point of escalation for RBQM and/or quality issues for the project team
Requirements
- Functional expert on ICH E6 and E8
- General knowledge of clinical trials
- RBQM subject matter expert
- Strategic RBM approach knowledge
- Change agent champion
- Experience with RCA and CAPA practices
- Effectively lead cross functional teams
- Strong communication/interpersonal skills
- Ability to influence without authority
- Creative and critical thinker
- Comfortable with challenging the status quo
- Comfortable with ambiguity
- Demonstrate a diversity and inclusion mindset
- Proactively anticipates critical risks/issues and develops contingency plans
- Understands ICON cross functional SOP/WI/workflows and cross-functional roles; translates project concepts into actionable plans
- Promotes knowledge sharing - Effectively mentor’s/Trains Functional leads/study team at all levels to comply with RBQM SOP/ICH GCP E6 & E8.
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
Quality & Risk Management Plan authoringRisk assessmentRisk-based monitoring strategyData review methodsProject Risk assessmentsRCA practicesCAPA practicesMonitoring strategy operationalizationQuality controlClinical trial knowledge
Soft skills
LeadershipCommunication skillsInterpersonal skillsInfluencing without authorityCreative thinkingCritical thinkingChange agentDiversity and inclusion mindsetProactive risk anticipationMentoring