Clinical Study Manager II

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Lead or support study operational strategy and planning and oversee execution of select clinical studies (global/regional and/or local country) for an assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan.

In close collaboration with Clinical Operations Program Lead(s)

• • Oversee the execution of select studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and SOPs), on schedule and on budget.
  • Oversee Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda’s
  • obligations described in ICH-GCP and Takeda’s business objectives.

ACCOUNTABILITIES

• 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
• Support budget development and ensures impacts are adequately addressed
• Participates in country and site feasibility/selection process, with a focus on providingcountry insights, alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy
• Develops and manages overall study timelines.
• Challenges study team to ensure timelines meet the needs of the clinical development plan
• Ensure new team members and vendors are appropriately onboarded
• Trial risk and mitigation identification and oversight
• Leader of the cross functional study team
• During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place
• Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly
  
• Supports for study budget planning and management and accountable for external spend related to study execution. Works closely with Clinical Operations Program Leader(s), 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 Clinical Operations Program Lead(s); serve as escalation point for third party 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;
• Specific areas of sponsor oversight include, but are not limited to:
• 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)
• Reviewing and 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.
• 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

• 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 require
• Demonstrated successful experience in project/program management and matrix leadership

o E.g. timeline/budget management

o E.g. Risk identification and management

Preference: Experienced Vendor selection and oversight

Good communication skills

• Excellent teamwork, organizational, interpersonal, and problem-solving skills
• Fluent business English (oral and written)
• 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 could 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.
• 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 of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.