Mgr Clinical Transparency

The Manager Clinical Trial Transparency (CTT) will work with the Clinical Trial Disclosure (CTD) Team and be responsible for assembling information for protocol registrations, updates and results postings on ClinicalTrials.gov and other applicable websites as per Clinical Trial Registration & Results Disclosure requirements worldwide. The CTT Specialist will partner with representatives from Global Development to ensure accuracy and consistency across registries, respond directly to comments from government registry operations staff as needed and advise relevant functions of public release. CTT Specialist will provide functional groups' guidance on internal public disclosure processes and global regulatory requirements for registrations and results disclosure as needed
In this role, a typical day might include the following:

Collaborate with Study Teams and Collaborators to develop and facilitate approval of Registry and Reporting content

Assist with results reporting to global databases as required (eg, CT.GOV, EudraCT and ROW National Registries)

Help in the development of job aids, work instructions, training materials and procedures, as needed

Consults with relevant team functions within Global Development, such as, Clinical Operations, Medical, Biostatistics, Regulatory Affairs, and Medical Writing to review protocol information to acquire accurate, appropriate information for public disclosure.

Outlines requirements from multiple international disclosure laws and guidance and internal processes, and interprets requirements as appropriate for the type of study, and recommends information to be disclosed.

Enters and releases the initial protocol information and revised protocol information on clinicaltrials.gov and other websites as required by international law/guidance Policy

Interprets constantly evolving domestic and international laws and requirements for clinical trial results disclosure.

Consults with relevant team functions to assimilate the required results data fields for posting.

Ensures information is entered in appropriate databases and reviews information for accuracy.

Releases information to the public and responds to government agencies to resolve issues if needed.

Ensures sponsored studies are disclosed according to applicable laws, regulatory requirements and policies

Archives registration and results posting documentation

Communicates registrations and results dates and links to relevant partners

Updates existing registries with changes in ongoing clinical trial status including recruitment status, protocol amendments, site updates and actual dates

Monitors and tracks existing clinical trial registrations for future results posting and advises appropriate team members of upcoming timelines.

Serves as a driver to international clinical trial disclosure processes

Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs. Provide training on applicable requirements for scientific staff.

Develop regulatory strategies for assigned programs by analysis of guidances and assessment of drug developed for similar indication
This role might be for you if:

• Minimum of 2+ years of relevant industry experience
• Understands the legal/regulatory requirements and guidelines with regard to clinical trial disclosure, as well as ongoing discussions of pending changes
• Understands the clinical drug development process, including clinical trial design, operations and results analysis
• Have excellent organizational, interpersonal and communication skills, and is able to develop and present unique ideas
• Have outstanding attention to detail and the ability to analyze and assess data
• Have a proven understanding of MS WORD, Excel and Power Point