Manager, Clinical Trial Transparency
ICON Clinical Research
Manager, Clinical Trial Transparency (CTT) - EMEA
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Manager, Clinical Trial Transparency to join our diverse and dynamic team. As a Manager, Clinical Trial Transparency at ICON, you will play a pivotal role in ensuring the compliance and ethical transparency of clinical trial data, promoting accountability in the research process. You will contribute to the advancement of innovative therapies by overseeing the timely registration and reporting of clinical trial information.
**What You Will Be Doing:**
+ Leading the development and implementation of strategies to ensure compliance with global clinical trial transparency regulations and guidelines.
+ Manage and maintain a forward-looking book of work for clinical trial disclosure activities and conduct capacity planning and resource forecasting to ensure appropriate staffing levels and skillsets.
+ Collaborate with cross functional teams to align resources with study timelines and regulatory milestones.
+ Guide our clients in their global regulatory requirements to ensure timely and accurate registration, results reporting, and data sharing in compliance with global regulations (e.g., FDAAA, EU CTR, WHO, ICMJE).
+ Providing training and line management of a global clinical trial transparency team, fostering a culture of accountability, collaboration and ethical conduct.
+ Building strong relationships with regulatory agencies and internal stakeholders to facilitate effective communication on transparency initiatives.
+ Monitoring and reporting compliance metrics and conducting audits to identify areas for improvement and ensure adherence to transparency standards.
+ Provide operational input onto ICONs business activities including planning and forecasting, budget tools, business development activities.
**Your Profile:**
+ Bachelor’s degree in life sciences or related field (advanced degree preferred).
+ Over 5 years of experience in clinical trial transparency, medical writing, or regulatory affairs, including a minimum of 3 years’ hands-on experience in one or more key areas of clinical trial transparency such as trial registration and results disclosure, plain language summary development, or redaction and anonymization of clinical documents in alignment with data sharing policies
+ Thorough knowledge of global disclosure regulatory requirements and industry standards.
+ Strong leadership skills with the ability to motivate and guide teams effectively in a diverse environment.
+ Excellent communication and interpersonal skills, with a proven ability to influence stakeholders and promote a culture of transparency.
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**What ICON can offer you:**
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family’s needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site (https://careers.iconplc.com/benefits) to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 or submit a request here (https://careers.iconplc.com/reasonable-accommodations)
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here (https://wd3.myworkday.com/icon/d/task/1422$1235.htmld) to apply
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