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 function is responsible for clinical trial disclosure and data sharing activities. The ideal candidate will be responsible for executing registration and results disclosure and data sharing activities in accordance with sponsor requirements and international regulations.
The individual will participate on project teams to provide guidance on public disclosure and data sharing processes and requirements, including regulatory requirements for content and format.
- Develops and maintains effective policies and procedures for clinical trial disclosure and data sharing functions including identification of qualifying clinical trials, registration, and results disclosure and or data sharing. Ensures accurate, comprehensive and timely completion of required disclosure activities in applicable public databases and corporate disclosures websites.
- Keeps abreast of changes in local and international regulatory requirements regarding clinical trial transparency. Communicates changes to stakeholders. Updates processes as required to remain compliant.
- Establishes/manages department budgets, manages workload forecasting, resource balancing and ensures optimal utilization across one or more projects/programs.
- Maintains effective team by recruiting, selecting, orienting, training, and coaching employees; ensures a safe, secure, and compliant work environment; provides employees with professional development and growth opportunities. Achieves staff results by communicating job expectations; planning, monitoring, and appraising job results; coaching, counseling, and disciplining employees; developing, coordinating, and enforcing systems, policies, procedures, and productivity standards.
- Maintains quality service by enforcing quality and customer service standards; analyzing and resolving quality and customer service problems; identifying trends; and recommending system improvements.
- Proactively identifies risks and issues and proposes/implements sustainable solutions to resolve the problems and prevent from reoccurring.
- May serve as primary contact for organizations that manage disclosed clinical trials information such as the US National Institutesof Health (ClinicalTrials.gov) and the EU Clinical Trials Register website (EudraCT).Develops local processes and procedures for clinical trial transparency activities. Provides guidance to staff in the execution of day to day activities.
- Bachelor's Degree preferred
- Minimum of 3 years of experience in clinical research and/or regulatory affairs with a focus on GCP activities. Prior 2+ years of work in a QA Capacity preferred.
- Proficieny using Microsoft Office applications oreferred.
- Experience using Sharepoint preferred.
- Ability to manage multiple timelines and perform under strict timelines.
- Demonstrate ability to work across multiple functions.
- Excelled written and interpersonal skills.
- To qualify, applicants must be legally authorized to work in the United States/Canada and should not require, now or in the future, sponsorship for employment visa status.
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.
HeadquartersHeadquarters 4130 ParkLake Avenue - Suite 400 Raleigh, North Carolina 27612 United States
$1B to $5B (USD)
PRA Health Sciences has been acquired by ICON plc, creating the world’s most advanced healthcare intelligence and clinical research organization. ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently operates from 77 locations in 38 countries and has approximately 11,700 employees. Further information is available at www.iconplc.com and http://careers.iconplc.com/.
"A great company to work with"
Former Employee•Clinical Research Associate
I enjoyed working at PRA. The managers are helpful and have good work ethics. Although I disagree with the opinion of the HR policies for job termination, I respect the decision and appreciate the help and assistance of the immediate supervisors. I would recommend my friends to work with PRA to enhance their knowledge and professional carrier goals since the zero-tolerance policy related to work ethics and keeping up with the current industry rules and guidelines along with subject knowledge puts the employees among the high performers' list.
"Great training, laser focus on process"
It’s a great place to learn how things should be done. However the laser focus on process kills innovation in this ever evolving field. Advice to leadership
"Amazing workplace, little growth. "
Former Employee•Research Associate
Working at PRA was fun! You meet a lot of great people and you get a lot of downtime. This is an amazing job if you're in school. It's very repetitive work. You always get stuck with extra work when people call in. Which kind of leads to no break.
"Nice place to work"
Current Employee•Project Manager
Pros: I work exclusively with the client which is a big pharma company so no interaction with icon colleagues . Cons: too new to tell but in overall I can say that work environment is not bad.