Job Information
ICON Strategic Solutions Clinical Trial Transparency Associate in Helena, Montana
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.
The Clinical Trial Transparency Specialist is responsible for assembling information and authoring the necessary components for protocol registrations, study updates, and results postings on ClinicalTrials.gov and other applicable websites as per Clinical Trial Registration & Results Disclosure requirements worldwide. The Clinical Trial Transparency Specialist will collaborate work with study teams to ensure accuracy and consistency across registries, respond directly to comments from government registry operations staff as needed, and notify relevant functions of public release. The Clinical Trial Transparency Specialist will provide cross functional groups guidance on internal public disclosure processes and global regulatory requirements for registrations and results disclosure as needed.
Essential Functions of the Job (Key responsibilities)
Author and release the protocol information on clinicaltrials.gov, EudraCT and other websites as required by international regulatory law in a timely fashion.
Maintain trial information for ongoing clinical trials status including recruitment status, protocol amendments, site updates, and actual dates on clinicaltrials.gov.
Knowledgeable in required data fields for posting studies on clinicaltrials.gov and EudraCT.
Consult with relevant study teams to assimilate the required results data fields for posting.
Author and release the result summaries in a timely fashion to clinicaltrials.gov and EudraCT.
Respond to government agencies to resolve issues, if needed.
Ensure sponsor studies are disclosed according to applicable laws, regulatory requirements, and internal policy.
Communicate registrations and result dates and links to relevant stakeholders.
Monitor and track existing and upcoming clinical trial registrations and results summary postings and
notify appropriate team members of upcoming deadlines.
Assist in the development of internal work instructions, training materials, and procedures as needed to comply with global requirements.
Ability to work with minimum supervision and resolve issues.
Develop and maintain collaborative relationships internally to ensure effective and efficient working
relationships and the delivery of high quality deliverables.
Stay informed of new clinical trial disclosure and transparency requirements globally including but not limited to clinical trial registration, posting of results.
Qualifications (Minimal acceptable level of education, work experience, and competency)
Bachelor Degree in a scientific or technical field.
Minimum of 3 years of work experience in either the health sciences or related industries (pharmaceutical, CRO, etc.)
Working knowledge of the global regulatory guidelines pertaining to clinical trial disclosure and transparency
Demonstrate experience in global clinical trial disclosure and transparency processes and systems.
Demonstrate Excel and analytical skills, working knowledge of SharePoint.
Strong communication, organizational, time management, and project management skills are required
Knowledge of ICH-GCP, awareness of clinical publication practices and standards (ie, ICMJE).
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required
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.