Clinical Trials Data and Disclosure Manager

Proclinical is currently seeking a Clinical Trials Data and Disclosure Manager for a biotechnology company located in the greater New York area. Successful candidate will be responsible for managing Global Clinical Trial Registration & Results Disclosure activities.

Job Responsibilities:

• Work with R&D Actors to review protocol information to obtain accurate data for public disclosure.
• Manage the public registries as end to end process from initiation, monitoring to archiving.
• Plan and prepare registrations and results for public registries according to current guidelines.
• Liaise with R&D Actors to prepare the dataset of summary results for posting. Ensure data is entered appropriately and validate the accuracy of the full dataset before posting.
• Post protocol data and results summary into the public registries and answer to the Request for Information from Regulatory Bodies.
• Monitor timelines and liaise with the R&D actors if needed.
• Participate in development of a Trial Registration Platform.
• Assist the Senior Management to prepare the implementation of transparency requirements.
• Assist the Senior Management to develop a patient centered approach.
• Task management and performance management of contractors or junior employee may be required.

Skills and Requirements:

• 5+ years of relevant experience and a BA/BS or 3+ years with MA/MS or above.
• Preferably 2+ years of direct experience in disclosures and/or data transparency, clinical operations or medical writing/clinical submissions.
• Core understanding and familiarity with Clinical Development, Clinical Trial conduct, and the Regulatory Submission process is preferred.
• Embracing the transparency trend. Well-aware about the environment and the involvement of non-profit organization.
• Exceptional attention to details and ability to analyze and assess data.
• Knowledge of statistical methods in clinical studies and publication results, Clinical Trials Management Database.
• Excellent knowledge of public registries, especially EudraCT and Clinicaltrials.gov.
• Working knowledge of business software, including MS Office, Adobe Acrobat and Outlook.
• Experience in the preparation and submission of documents using regulatory/document management systems is a plus.
• Excellent oral and written communication skills.
• Experience working in cross-functional teams is highly preferred.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Nicole Aganon at (+1) 347-293-1161 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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