Job Description/Responsibilities

Plans and executes clinical trial registrations, results postings, and maintenance of trial registry records, according to all applicable laws, regulatory requirements and policies
Engaging with both internal and Sponsor study teams for the planning, initiation and delivery of clinical trial registration and result postings on Clinicaltrials.gov, EudraCT and other global registries where applicable.
Contributing to the development of requests for Information/proposals, generation of contracts and budget for disclosure deliverables
Manages the procedures and standards that will support submissions to ClinicalTrials.gov, EU CTIS, and other global registries.
Conducts quality reviews of clinical trial disclosure deliverables, tracks compliance and compiles metrics for all disclosure-related activities
Acts as a clinical trial disclosure subject matter expert to study teams in communicating disclosure policies, processes, and system requirements
Acts as a clinical trial disclosure subject matter expert to enhance intra-department education and promote the transparency team activities within ICON.
Supports and develops relevant training and process-related documents, including internal guidance, standard operating procedures (SOPs) and work instructions (WIs)
Performing peer review and disseminating subject matter expertise to ensure highest quality deliverables.
Adhering to project plans and timelines for studies assigned
Keep abreast of changes in national and international transparency regulations.
Works with other functions to implement technology solutions related to clinical trial disclosures where applicable

Qualifications

Working knowledge of legal/regulatory requirements and guidelines relating to clinical trial disclosures.
Bachelor's degree in a scientific discipline, or other relevant discipline
Typically requires around 5 years of experience working in a clinical trial transparency / disclosure, clinical trial operations, medical writing, regulatory affairs or related environment in a pharmaceutical industry and/or clinical research experience.
Good understanding of the clinical development process, including clinical trial design, operations and results analysis
Strong organizational, interpersonal and communication skills for effective communication of information in complex situations
Demonstrated analytical skills and ability to interpret scientific content
Ability to work in a team environment and across all levels of the organization
Ability to multitask and prioritize multiple projects under evolving timelines
Competent in Microsoft Office (Word, Excel, PowerPoint) and Outlook; experience with Adobe Acrobat

Please note, this role is open to any remote working location in the UK.

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.

Apply here: https://bit.ly/3TMd1gJ

Clinical Trial Transparency Manager