Sr. Clinical Documentation Associate, Site Start Up

Location
Tarrytown, New York, US
Posted
Nov 01, 2018
Ref
14646BR
Required Education
Bachelors Degree
Position Type
Contract
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 Documentation Associate - Site Start-up, will serve as the primary contact for the requirements, coordination and review of essential documents required for release of Investigational Product on site for the conduct of a clinical trial. The CDA-SSU will also ensure the clinical study documents are filed in the electronic Trial Master File (TMF) from the beginning of the study until study completion in compliance with SOPs and guidances.

Job Duties:

• Review and assess study documents required for site activation and investigational product release according to relevant SOPs and regulations, provide feedback to provider as necessary.

• Maintain metrics on results of study documentation reviews and provide to management periodically.

• Ensure all relevant documents are uploaded into the Electronic Trial Master File (eTMF)

• Provide applicable essential documents to regulatory for submission to the FDA

• For inhouse studies (typically phase 1), prepare and distribute regulatory documentation packages for site completion.

• Filing/uploading of essential clinical documents and maintenance of the TMF as applicable

• Prepare and maintain transmittals and trackers of essential documents as applicable

• Manage the exchange of TMF documents with external service providers as applicable

• May maintain file QC schedule for assigned studies and performs periodic quality checks and inventories of study/project TMFs to ensure completeness and inspection ready

• Effectively communicate and drive study document management compliance and quality issues to line manager and offer potential solutions.

Requirements:

• Ability to travel approximately 10-15% in support of inspections or audits

• Proficient in oral and written communication, excellent organizational skills and the ability to manage multiple tasks with great attention to detail

• Good interpersonal skills with an ability to work in a team environment and independently

• Must be flexible and able to handle a fast paced environment

• Familiarity with clinical trial processes and ICH/GCP guidance and working knowledge of essential documents

• Ability to think critically and problem solve

• Knowledge of eTMF systems

• Understanding of the TMF reference model or similar filing structure

• Proficient in Microsoft Office software applications
3+ years in essential or regulatory document management in Pharmaceutical /CRO industry, understanding of clinical study start up requirements and working knowledge of relevant documentation.

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.

LMR, documentation, clinical documentation., #LI-LR1