Clinical Research Scientist

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Job description

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.

*You will;*

Work with the Study Medical Monitor/Study Clinical Scientist and provide scientific and clinical support from ongoing early and late stage clinical trials with an emphasis on protocol-specific, in-life clinical data monitoring activities. This role will also serve as a point of contact for CROs,investigators and study staff in day-to-day safety monitoring under the guidance of the Study Medical Monitor. This individual will report into Global Clinical Operations , and will interface directly with the Study Clinical Scientist and other cross-functional team members (including Clinical Development, Global Clinical Operations, Data Management, Biometrics, Patient Safety, Clinical Pharmacology and Biomarkers,) to support clinical study execution and clinical data monitoring.

*Responsibilites;*

• Support Medical Lead/Lead Clinical Scientist with medical monitoring reports, safety reviews, site interactions, and reviewing TFLs. Responsible for analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations to Medical Lead. Analyze and synthesize information to assess issues relating to protocol conduct and/or individual subject safety.

• Provide clinical operational support for Data Monitoring Committees including operationalizing the charter, preparing updates and blinded data reviews, execution of meetings and adjudications, and communication of synthesized data reports.

• Contribute to ICFs, training documents, literture reviews and other clinical and regulatory documents under the direction of the Medical Lead/Lead Clincal Scientist.

• Interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical trial objectives; responds to or triages questions for appropriate escalations.

• Contribute to the organization, preparation, and execution of investigator and advisory board meetings in collaboration with the project team and external vendors.

*We're looking for someone who has;*

* Experience in analysis and interpretation of clinical data (including safety and efficacy); working knowledge of GCP and clinical trial execution.

* Experience working with clinical trial sites.

* Experience in all stages of drug development

* Ability to make independent, timely and appropriate decisions.

* Ability to handle multiple projects at a time and have a strong attention to detail Excellent oral and written communication skills and solid computer/analytical skills.

* Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.

ICON 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.