ICON Strategic Solutions · 1 day ago
Clinical Study Manager
United States
Full-time
Remote
Senior Level
5+ years expICON plc is a world-leading healthcare intelligence and clinical research organization. They are currently seeking a Clinical Study Manager to lead or support Post Trial Access work within the RATIO team, ensuring compliance with quality standards and overseeing the execution of clinical studies.
Pharmaceuticals
Responsibilities
Accountable for planning and operational strategy and execution for assigned clinical trials
Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents
Challenges study team to ensure operational feasibility, inclusive of patient and site burden
Supports budget development and ensures impacts are adequately addressed
Participates in country and site feasibility/selection process, with a focus on providing country insights, alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy
Develops and manages study timelines
Challenges study team to ensure timelines meet the needs of the clinical development plan
Ensures new team members and vendors are appropriately onboarded
Identifies and oversees trial risk and mitigation
Leader of the cross functional study team
Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly
Supports/reviews study budget planning and management and accountable for external spend related to study execution. Works closely with COM (if applicable) and COPL, Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to COM and COPL; serve as escalation point for all vendors managed by Strategic Partner and/or other CROs
Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted
Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring
Conduct Oversight Monitoring Visits, as applicable
Review and endorsement of relevant study plans, as applicable
Study team meeting management and attendance when necessary; regular review of meeting agendas and minutes
Review of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the study
Documented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies
Review and ownership of trial operational data (e.g. CTMS)
Review and provide oversight of internal trial reports
In partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR
Support data review for database lock and CSR writing and review (including appendices)
Collect/review/File study documents in support of the trial master file (TMF)
Collect/review/File study documents in support of the regulatory filing
Responsible for overseeing study financial reconciliation
Ensure studies are “inspection ready” at all times; may be involved in regulatory inspections by preparing for and/or attending the inspections
Site relationship management
Review and provide oversight of trial audits
Proper and timely follow up to audit findings and CAPAs
Preparation for Agency inspections, including document readiness, tracking, storyboard development and other pertinent documents and preparations
Qualification
Required
Bachelor's Degree or international equivalent required; Life Sciences preferred
Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required
Demonstrated successful experience in project/program management and matrix leadership. Including timeline/budget management and risk identification and management
Works independently and is highly organized
Good communication skills
Excellent teamwork, organizational, interpersonal, and problem-solving skills, including experience with Leading cross-functional teams, vendor selection and oversight
Experience managing recruitment challenges and boosting enrollment
Fluent business English (oral and written)
Experience of managing post trial access is required for this particular role
5+ years' experience in pharmaceutical industry and/or clinical research organization, including 3+ years clinical study management/oversight, including significant study management support experience (e.g. clinical trial assistant/associate or lead CRA)
Experience should include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Experience in more than one therapeutic area is advantageous
Preferred
Advanced degree(s) (e.g. Master or Doctorate) and relevant training or experience (e.g. fellowship, internships, etc.) may be considered to supplement experience requirements
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, 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.
Company
ICON Strategic Solutions
ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services.
10001+ employees
H1B Sponsorship
ICON Strategic Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (1)
2021 (2)
2020 (3)
Funding
Current Stage
Late StageLeadership Team
Jennifer Alamo Linnell
VP, HR Business Partnering
Aimée Guzmán
External Partnerships Project Manager & Site Lead | Providing Services for J&J Innovative Medicines
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