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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.

Accountabilities (Responsibilities)

• Provides Project Oversight and Leadership for Clinical Deliverables:

• Leads and manages the start-up and clinical teams

• Plans and leads execution of the day to day activities for the monitoring

• of a clinical study and communicates consistently with the clinical team providing project

• objectives, expectations and status updates. Works with the team to set priorities

• Takes the initiative to make things happen and leads and supports the relevant staff ( this

• may include but is not limited by Country Start Up Specialist (CSS), Global Regulatory Affairs

• Lead (GRAL), Local Regulatory Affairs

• Lead (LRAL) and In-House Clinical Research Associate (IHCRA)) to ensure the successful

• activation of trial sites according to time, quality/scope and budget parameters

• Ensures effective communication plans are place for the clinical team

• Ensures effective escalation plans are in place for the clinical team

• Works with the Project Manager (PM) to facilitate cross functional team and sponsor

• communication for proactive, study-wide problem solving regarding study progress and trial

• issues during the study

• Monitors the quality of clinical deliverables and addresses quality issues with the

• appropriate team member

• Reviews and approves site visit reports within agreed turnaround times and ensures

• tracking, follow up and resolution of site issues

• Identifies opportunities to improve training, execution and quality control across the team

• Liaises with relevant staff to provide data as required for clinical operations performance

• metrics and project status metrics

• Works with the relevant staffto identify data related issues and risks to clinical activities;

• develops contingency and mitigation plans to minimize risks.

• Attends Executive Project Status Reviews as required

• Project Resourcing

• Works with the relevant staff (including Director of Project Delivery (DPD) when applicable)

• to ensure all Clinical team members are adequately assigned to the project

• Forecasts as per the contractually agreed FTE, tailoring forecasts to peaks and flows of

• activities throughout the project duration

• Actively monitors initial and ongoing clinical resource and identifies/escalates issues to the

• Project Manager (PM) and/or Clinical Management when applicable

• Liaises with Clinical Operations Managers to resolve clinical resource and performance issues

• Disseminates and agrees forecasted activities/FTE to all key team members

• Oversees transition plans to allow seamless transition of knowledge in case of CTM or

• clinic team member replacement

• Quality – Training & Development

• Creates and maintains project specific plans, documents and tools for the clinical team.

• Plans, oversees and conducts initial and ongoing training for the relevant study staff on

• clinical project specifics

• Analyzes data related to sites activation, monitoring, data retrieval and close out to identify

• issues and risks to clinical deliverables; develops contingency and mitigation plans to

• minimize risks; communicates risks & mitigation strategies. Supports the Clinical Research

• Project Finance

• Provides Time Entry Guidelines to the relevant study team members in adherence with

• project scope and budget; monitor burn rates, escalating issues with potential solutions to

• the Project Manager (PM).

• Forecasts units and hours and generic resources for the start-up and monitoring activities,

• determines worked units and hours, analysing forecasted and worked activities to ensure

• adherence to contract and budget

• Ensures that forecasted units are achieved as planned and within the budgeted FTE

• Identifies out-of-scope tasks from clinical team and escalates as required

• Ensures no out-scope tasks be conducted without the required evidence of agreement from

• the client or approval by the relevant PRA staff.

• Customer Relations (Internal & External)

• Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required.

• 5+ years of clinical research experience required, including at least 2 years experience in clinical trial management Read, write and speak fluent English; fluent in host country language required.

• Experience in managing all trial components (start-up to database lock) preferred Experience in coaching/mentoring other CTMs, leading a team of CTMs, participating in departmental initiatives preferred

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.

ID: 2022-93473

External Company Name: Pharmaceutical Research Associates, Inc

External Company URL: http://prahs.com/