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 (CTT) Manager is responsible for the operational execution of ICON's clinical trial disclosure activities, including managing protocol registration and results postings, on local, national or regional clinical trial registries including EudraCT/EU CTIS and ClinicalTrials.gov. The CTT Manager will partner closely with functional groups and external and internal stakeholders to ensure that trial disclosures adhere to internal processes/strategy and comply with all applicable laws, regulations, policies and registry requirements. The CTT manager will be a Subject Matter Expert in all aspects of trial disclosure and have a good knowledge of other aspects of transparency so they are able to work in a multi-functional and diverse team of experts. The role will also contribute to the development and maintenance of processes and standards that support compliance with current or future global clinical trial disclosure requirements along with promoting the need for transparency both internally and to the wider external audience. The CTT manager will be the go to expert on disclosure for both other functional ICON teams and Clients alike.
The Clinical Trial Transparency function will also be responsible for clinical trial disclosure activities. The ideal candidate will be responsible for executing registration and results disclosure in accordance with sponsor requirements and international regulations.
The individual will participate on project teams to provide guidance on public disclosure and requirements, including regulatory requirements for content and format.
The Clinical Trial Transparency (CTT) Manager is responsible for the operational execution of ICON's clinical trial disclosure activities, including managing protocol registration and results postings, on local, national or regional clinical trial registries including EudraCT/EU CTIS and ClinicalTrials.gov. The CTT Manager will partner closely with functional groups and external and internal stakeholders to ensure that trial disclosures adhere to internal processes/strategy and comply with all applicable laws, regulations, policies and registry requirements. The CTT manager will be a Subject Matter Expert in all aspects of trial disclosure and have a good knowledge of other aspects of transparency so they are able to work in a multi-functional and diverse team of experts. The role will also contribute to the development and maintenance of processes and standards that support compliance with current or future global clinical trial disclosure requirements along with promoting the need for transparency both internally and to the wider external audience. The CTT manager will be the go to expert on disclosure for both other functional ICON teams and Clients alike.
The Clinical Trial Transparency function will also be responsible for clinical trial disclosure activities. The ideal candidate will be responsible for executing registration and results disclosure in accordance with sponsor requirements and international regulations.
The individual will participate on project teams to provide guidance on public disclosure and requirements, including regulatory requirements for content and format.
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
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 through the form below.
