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Employment type: Permanent - Full-Time
Location: Bangalore, Hyderabad, Pune
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.
With our patients at the center 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.
Position Summary :
Primary point of contact between site staff and NN. Acts as ambassador for the company and contributes to making NN the preferred partner.
Responsible for taking leadership of site management for the selection and initiation of sites as well as conduct and closing activities of the appointed studies in compliance with local regulations, ICH-GCP, NN procedures and protocol requirements to ensure data quality and study subject protection.
Responsible for managing the site to meet patient recruitment rate and target.
Delivers results that have direct impact on the successful completion of the clinical program.
Coordinates with PM and communicates to them progress and critical issues that may impair trial progress.
Performing monitoring visits according to plan, document actions and follow up on action plans Site feasibility visits incl. analysis of site logistics, site personnel performance/quality indicators
and accountability for patient recruitment strategies
Train and guide site staff in the protocol and trial procedures to minimize protocol deviations(PDs)
Train site staff in safety information handling and systems
Know and meet all local and company requirements with respect to safety reporting
Proactive use of EDC and other data source systems for preparation and conduct of site visits as well as source data verification in collaboration with data management/logistics team
Identify potential risks and proactively take action to prevent or mitigate
Collaborate with Data Management/logistics in resolving queries
Ensure data cleaning cycle timelines are met in accordance with the Data Flow Plan
Manage trial product requirements, incl. temperature deviations and training of site staff
Motivate and build strong relations with site personnel to ensure NN is their preferred clinical research partner
Ensure collaboration with and deliverables from vendors locally, if applicable
Collection and management of essential documents
Support the site in filing and archiving trial documentation in the Investigator Trial Master File (ITMF)
Participation in Investigators Meetings to ensure relations with sites as well as active presentation as applicable
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.
Would you like to know more? Please submit your CV to Kalpana.Kulasekaran@docsglobal.com
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