- $64,190.00 -83,300.00/year*
8 Dorchester Rd
Ascent Life Sciences is hiring a Clinical Trials Disclosure Associate immediately for a 12 month contract. As the Clinical Trials Disclosure Associate you will oversee the end-to-end operations for clinical trials registration and results posting on clinicaltrials.gov, EudraCT, and similar databases worldwide (disclosure operations process). To ensure disclosure operations, vendor and study teams perform activities in accordance with our policy for Clinical Trial Data Access and the Disclosure of Clinical Trial Information and applicable regulations. Work will be mainly office-based in an open plan environment with flexibility to work from home, adhering to the company rules. The position does not currently have line management responsibilities.
- Performing/coordinating all activities for the registration and results posting to clinicaltrials.gov, EudraCT, and similar databases worldwide in compliance with policy and procedures, and applicable regulations
Working closely with the internal team and vendor to ensure they understand their roles and responsibilities related to the company?s disclosure obligations
- Works with the internal team to ensure the source information is provided for disclosure activities in a timely manner
- Working closely with the vendor to ensure that the studies get registered and results get posted to major registries in compliance with policy, procedures, and applicable regulations
- Ensure company?s disclosure information is maintained and in compliance with relevant procedures
- Maintain process documents and training materials in line with regulation updates and acquired knowledge as required
- Raising awareness of clinical trial disclosure and its changing requirements within the company globally as required
- Supporting other clinical transparency activities within GCTT as required
- Education to B.S. level or equivalent
- Good knowledge of clinical disclosure rules such as FDAAA801, EudraCT, PhRMA/EFPIA principles for responsible data sharing, etc.
- Demonstrated experience in the pharmaceutical industry, with exposure to least one of the following areas; Clinical trial transparency, Clinical trial disclosure, Medical writing
- Understanding of clinical development within the pharmaceutical industry
- Experience with study registration and results disclosure on clinicaltrials.gov
- Experience of supporting and managing tasks / projects, by establishing strong relationships and coordinating those resources (internal and external) to achieve deliverables in compliance with process and / or contract
- Experience of working with different software packages and platforms
- Track record of driving and successfully completing time-sensitive projects across multiple departments
- Ability to use various systems such as: MS Office, especially MS Excel, Sharepoint, Document Management System (Documentum), Company?s Clinical Trials tracking database, Data entry portals for publicly accessible registries, Vendor platforms and databases
- Strong verbal and written communication skills that enable effective global meeting facilitation, makes difficult concepts easy to understand, and demonstrates ability to articulate difficult issues
- Ability to quickly become a SME for software packages, IT platforms, databases etc. that support GCTT operations
- Team player able to form strong (internal and external) relationships, demonstrating an ability to influence/persuade others
- Ability to handle multiple tasks and/or projects simultaneously
- Ability to drive projects with conflicting priorities in a matrix team environment, working with individuals from a variety of departments and in a range of countries
- Ability to understand and apply international regulations and company?s guidelines and requirements related to clinical trial transparency
- Flexible and proactive
- Eye for detail
?For immediate consideration please email resume to Neha Potdat at ...@ascentsg.com?
Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascent s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts.
If you are ready to propel your career to new heights read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.
Associated topics: clinical, clinical development, clinical informatics, clinical trial, coordinator, lab, laboratory, research, research coordinator
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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