Temp - Senior Clinical Documentation Associate Contractor (TMF Lead)

Location
Tarrytown, NY, United States
Posted
Nov 15, 2020
Ref
22339BR
Required Education
Bachelors Degree
Position Type
Contract
The Senior Clinical Documentation Associate collaborates with the clinical study team to set up, manage and oversee the study trial master file (TMF). This role crafts and maintains the TMF plan and the study-specific inventory list. The TMF Lead is also responsible for locking the TMF at the end of the study following approval by all functional areas.
In this role, a typical day might include:
• Serving as the steward of the study eTMF to make sure the process to ensure completeness, quality and timeliness is followed by the study team.
• Optimally communicate and drive document management compliance and quality issues to the clinical study teams and management.
• Presenting eTMF at study Kick-off meeting and investigator meetings (CRA training) and attend regular study team meetings as applicable to report on the status of the TMF
• Supporting the study teams to ensure study TMFs are submission and inspection ready at all times.
• Preparing the study specific TMF plan and corresponding study inventory list and insure they are current throughout the study and finalized at study completion.
• Conducting documentation reviews of the TMF looking for areas missing significant documentation, logical checks (missing versions, missing documentation from 1572 participants, accurate number of sites, etc), gross errors in location, inconsistencies in naming conventions.
• Ensuring QC reviews are conducted as prescribed in the TMF plan and that issues identified are addressed
• Supporting the study team during inspections and audits as necessary.
• Handling deletion/demotion requests throughout the duration of the study (Once Veeva eTMF workflow is in place)
• Answering any filing queries or general Veeva eTMF questions from CRO/study team
• Ensuring Veeva eTMF is set up for the study and that countries and sites are added as needed
• Up to 10% travel

This role may be for you if:

You have a proven, deep understanding of the TMF Reference model and processing of documentation into the eTMF system.
You have the ability to build the TMF plan and ensure compliance by the study team
You can prioritize and run multiple projects simultaneously
You have excellent interpersonal skills with the ability to collaborate effectively across all levels of an organization
You are highly self-motivated, flexible, able to follow through in an ambiguous, constantly evolving environment
Highly organized and detail oriented, with the ability to meet deadlines under pressure

To be considered for this opportunity you must have a degree or equivalent. At least three years of experience is required. Proficiency in Microsoft Applications is also vital for success in the role.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.