Ref #: 32933

Employment type: Permanent - Full-Time

Location: China-Shanghai

Posted: 11-Oct-2021

Description

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 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.

Provide documented sponsor site oversight at country level for outsourced trials in country under remit as required by regulation. Utilize site performance and quality data to optimize prioritization of oversight actions.

Functional Tasks:
1.Builds and manages site relationships
2.Oversees site-level study start-up, conduct, and close-out activities outsourced to a CRO for global programs across different Therapeutic Areas, including without being limited to
o Supports Site Agreement negotiations, including stand-alone and Master Site Agreements
o Identifies trends, issues and risks across sites, and works with external vendors as well as the with the Clinical Trial Team to resolve/mitigate those
o Ensures, in collaboration with external vendors as well as internal Clinical Trial Team that the sites under his/her area of responsibility are activated in a timely manner and according to company’s agreed timelines
o Ensures, in collaboration with external vendors as well as internal Clinical Trial Team that the sites under his/her area of responsibility deliver on expected recruitment targets, including identifying reasons for non-recruitment, and identification of non-performing sites that require actions
3.Acts as liaison between the company and investigational sites building investigator and site staff awareness on Merck/EMD Serono compounds
4.Develops and implements a plan in collaboration with the global and local organization to raise the profile of the company and its global clinical development projects with current and potential investigators
5.Independently perform activities associated with the evaluation of investigational sites to build company network
6.Ensures ICH/GCP/local regulatory requirements are observed
7.Proactively works with Medical/Patient/Industry Associations to build company network and to promote company clinical trials
8.Develops the knowledge of site capabilities and past performance to assess their potential as participating sites in Merck/EMD Serono clinical trials
9.Ensures regular communication with local organizations to align interactions with KTLs and other relevant local/regional stakeholders
10.Function requires domestic and international travel up to 70% of time

Interfaces with other Departments/Functions/Roles:
1.Regional Clinical Operations;
2.Clinical Trial Management: Clinical Trial Coordinator/Clinical Trial Lead/Clinical

Operations Lead (CTC/CTL/COL);
• Global Clinical Data Sciences (GCDS);
• Clinical Quality Management (CQM);
• Medical Affairs (MA);
• Research and Development Quality (RDQ);
• Regulatory Affairs (RA)
• Clinical Development Center (CDC)

External Interfaces:
• Clinical Research trial sites (Institutions/Investigators)
• Ethics Committees/ Regulatory Authorities (e.g., ECs/IRBs); if applicable
• Hospital administration
• Pharma Industry working groups
• Vendors (CRO)
• Patient Associations

To be successful in the role, you will have:

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.


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