PRAHS Clinical Team Manager 1 in United States
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.
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
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
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.
External Company Name: Pharmaceutical Research Associates, Inc
External Company URL: http://prahs.com/