Clinical Transparency Manager

Location
Tarrytown, New York, US
Posted
Sep 23, 2018
Ref
14070BR
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

SUMMARY: The Clinical Transparency Manager is responsible for managing Global Clinical Trial Registration & Results Disclosure activities. These activities include the registration of protocols and results postings on appropriate clinical trial registries, and development and implementation of clinical trial transparency activities in accordance with relevant laws, regulations, and SOPs. The Clinical Transparency Manager will provide functional groups guidance on internal public disclosure processes and global regulatory requirements for registrations and results disclosure as needed. The Clinical Trial Manager will

JOB RESPONSIBILITIES:

• Consults with relevant team functions within Global Development, such as, Clinical Operations, Medical, Biostatistics, Regulatory Affairs, and Medical Writing to review protocol information to obtain 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

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

• 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

• Monitors and tracks existing clinical trial registrations for future results postings and notifies appropriate team members of upcoming deadlines

• Archives registration and results posting documentation

• Communicates registrations and results dates and links to relevant stakeholders

• Participates in group initiatives and authoring of training manuals, checklist documents, business practices, or standard operating procedures (SOPs)

• Manage vendors, as needed

• Provides CRO oversight, as needed

• Serves as a member of the Clinical Data Transparency team

JOB REQUIREMENTS:
Education

• Bachelor's degree (advanced degree preferred) in science or a health profession
Experience

• Minimum of 5+ years of relevant industry experience

• Understands the legal/regulatory requirements and guidelines with regard to clinical trial disclosure, as well as on going discussions of pending changes

• Understands the clinical drug development process, including clinical trial design, operations and results analysis

• Has excellent organizational, interpersonal and communication skills, and is able to develop and present varied and unique ideas

• Has exceptional attention to details and ability to analyze and assess data

• Has a good working knowledge of MS WORD, Excel and Power Point

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.