Clinical Trial Manager

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.

 Key Purpose:

•   Primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up (COLA) to close out at a       

      country level in accordance with ICH-GCP and other applicable local regulations

• Maintain the quality and scientific integrity of clinical trials at a country level.
•  Collaborate with cross functional internal and external stakeholders to ensure timely execution, budget execution of clinical trial.

      deliverable within the country

•  Maintain expert country, site and protocol knowledge to support sites with questions as well as build strong site relationships.
• Partner with global, local country teams and study team to provide high level country strategy, drive study progress and country level

         study delivery. (Accountable for study deliverables and drives key decisions within set country)

•  Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through

        leadership of the cross-functional Local Study Team (LST)

•    Supports country-level operational planning and accountable for site selection within assigned country(ies)
•    Contribute and develop to program,/study-specific materials – e.g., monitoring plan, study specific training documents.
•   Support and contribute to Clinical Study Teams (CSTs) / Trial Management Teams

   (TMTs) as applicable, agenda driven, present at meetings.

•   Communicate country status (including timelines and deliverables) to key stakeholders (e.g., GCMs, Program Managers, CST or TMT,

          DOM etc) with oversight as required and ensures updates to relevant systems

•   Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country(ies)
•    Contribute to, deliver and/or lead CRA, Investigator and Study Coordinator training
•  Oversight and monitoring of applicable vendor activities e.g., laboratories and equipment provisioning

     Engage with local cluster team and local functions from a study perspective (e.g., Local Medical, DOM).

   Provides country level input into the Country Operational Plan (COP) and partner with the DFM through feasibility and with the

          GCMs to ensure local delivery of the study.

          Accountable for approval of Baseline and Revised Enrolment Plans (Country Level)

•   Contribute to the study-level forecast for investigational product, support study level accountability and reconciliation across 

          assigned countries, management of ELE (enrolment long-range estimates)process

•    Monitor the execution of the clinical study against timelines, deliverables, and budget for that country:

   Translate global start up requirements into local country targets

•    Monitor country enrolment and retention and act on deviations from plan. Identify barriers to enrolment and support recruitment

          and retention strategic solutions.

•   Monitor and act upon data flow metrics - review, trend identification and analysis, with targeted follow up where appropriate
•      Monitor and review country and study trends

    Review Monitoring Visit Reports

•     Identify and facilitate resolution of cross-functional study-specific issues
•    Provide updates regarding the study budget and obtain approval for budget deviations for clinical sites (outside of range)
•      Escalate any issues related to delivery, timelines, or budget to GCMs.

Basic Qualifications:

    Doctorate degree OR

    Master’s degree 3 years of directly related experience OR

    Bachelor’s degree & 5 years of directly related experience OR

    Associate’s degree & 10 years of directly related experience OR

    High school diploma / GED & 12 years of directly related experience

    Advanced knowledge of global mimimum 2-3 years’ experience of leading local/regional or global teams

    Minimum 2-3 years’ clinical trial project management experience

    7 years’ work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience 

    obtained working on clinical trials in a biotech, pharmaceutical or CRO company

    Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)

Knowledge:

• Project Management  skillset
• Critical thinking and horizon scanning
• Problem solving
• Decision making
• Delegation skills
• Relationship Management  and influencing skills
• Cross functional team leadership - a team player with the ability to take initiative and lead
• Ability to work effectively in a team/matrix  environment on multiple projects
• Proven ability to work independently and effectively handle multiple priorities in a fast-paced environment
• Risk management skills
• Strong organizational,  self-management  and planning skills
• Strong verbal reasoning, attention to detail, critical thinking, problem solving and analytical abilities
• Excellent interpersonal skills and effective communication across all levels within an organization
• Data analytics skills – using data to enhance performance and delivery
• Strong oral and written communication skills
• Time management
• Business English
• Delivery and risk focused
• Adaptability and Flexibility
• Demonstrable ability to work effectively cross-culturally and in a virtual work environment
• Strong IT computer literacy, including word processing, presentation, and spreadsheet applications