Clinical Trials Disclosure Associate(Manager, Global Clinical Trial Transparency, MDC) (19-00666) – NJ – Woodcliff Lake

Job title: Manager, Global Clinical Trial Transparency, MDC

Main purpose of the job:

To 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 Client’s Policy for Clinical Trial Data Access and the Disclosure of Clinical Trial Information and applicable regulations.

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Will include but will not be limited to the following activities:
• 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 Client team and vendor to ensure they understand their roles and responsibilities related to Client’s disclosure obligations
• Works with the internal Client 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.
• Disclosure Tracking Database: ensure Client’s disclosure information are maintained and in compliance with relevant procedures
• Process and Training: maintain Client 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

• Work will be mainly office-based in an open plan environment with flexibility to work from home, adhering to the company rules.
• Software/computer systems used mainly include:
o MS Office, especially MS Excel
o Sharepoint
o Document Management System (Documentum)
o Client Clinical Trials tracking database
o Data entry portals for publicly accessible registries
o Vendor platforms and databases

• The position does not currently have line management responsibilities
• Internal: close collaboration with Client departments worldwide managing studies, such as clinical operations and local affiliates (EU, US, Japan, China, other Asian countries)
• External: close collaboration with an external vendor (tasked with tracking, summary writing, and posting of information)

• Education to B.Sc. 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;
o Clinical trial transparency
o Clinical trial disclosure
o 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

• 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 Client guidelines and requirements related to clinical trial transparency.
• Flexible and proactive.
• Eye for detail.
Source: Job Diva – Job Listing

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