PRAHS Clinical Research Manager - General Medicine - Home Based 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
What you will be doing:
Main POC for assigned protocols and link between Country Operations (CO) and clinical trial team (CTT).
Project management of assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
Accountable for performance of assigned protocols in country in compliance with ICH/GCP, country regulations, client policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Reviews Monitoring Visit Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management
Performs Quality Control visits as required
Leads local study teams in high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert & coordinates activities across different local country roles.
Creates and executes local risk management plans
Supports compliance with CTMS, eTMF and other systems
Escalates issues to TA Director/CRD/CQM/CTT
Collaborates with functional outsourcing vendors, investigators and other external partners in studies
Country POC for programmatically outsourced trials for assigned protocols
Serves local business needs in his/her country (if delegated, signs contracts and manages budgets)
Collaborates internally with HQ functions and locall with PV, Regulatory and GMA to align on key decisions
Builds business relationships and represents the client with investigators
Shares protocol-specific information and best practices across countries/clusters
What you need to have
Bachelor’s degree in science or similar required. Masters, PhD, MD preferred.
5-6 yrs. experience in clinical research required
Previous CRA experience required
Ability to travel up to 30%
Clinical trial management experience required
Project/Site Management knowledge
Demonstrated success of strong organizational skills
Strong understanding of local regulatory environment
Strong scientific and clinical research knowledge
Strong understanding of clinical trial planning, management and metrics
Ability to focus on multiple deliverables and protocols simultaneously
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status
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/