Trial Master File Specialist

Location
Rockville, MD, US
Posted
Mar 14, 2021
Ref
2021-9824
Hotbed
BioCapital
Required Education
Other
Position Type
Full time
Overview

We are currently searching for a Trial Master File Specialist to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Rockville, MD

Duties & Responsibilities

  • Assist with the development, implementation, and maintenance of the Trial Master Files (TMFs) to meet regulatory requirements.
  • Provide support and guidance to various functional areas supporting the TMFs, both electronic and paper.
  • Provide support of TMF operations during eTMF implementation, audits, and/or regulatory inspections.
  • Ensure TMF's are "inspection ready" at all times and TMF documents are filed contemporaneously in a timely manner.
  • Monitor and identify study trends, communicate issues, and escalate concerns to the federal client.
  • Liaise with Regulatory, Quality, and other task area leads to reconcile TMF documents which have been received from various functional areas to ensure completeness and quality of files.
  • Ensure compliance with ICH, U.S. federal regulations, and NIH policies and procedures.
  • Assist in the tracking of all TMF activities (essential document submission and status).
  • Participate in working groups and team meetings, as required.
  • Develop SOPs as required to ensure oversight of the TMF process.


Requirements

  • MPH or Master's degree in Regulatory Affairs or a Clinical Trials field.
  • Minimum of one (1) to two (2) years of experience working in the TMF field is essential.
  • Additional experience in clinical trial management or clinical regulatory affairs is preferred.
  • Demonstrated experience developing SOPs and other formal documents.
  • Excellent communications skills, both verbal and written.

#LI-DD1

Company Description

We are a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management.

The Dovel Family of Companies offers employees an opportunity to advance beyond a specific role or contract, we offer a path to develop an enriching career. We believe in empowering a culture of innovation, customer success, and employee growth.

What you'll get...
  • Time Off! Flexible schedules and company paid holidays allow you to take the time you need.
  • Investment in YOU! 401(K) company contributions are yours to keep with no waiting period.
  • Choices! Unique healthcare plans to choose from with options like fertility and orthodontia benefits.
  • Discovery! With our tuition assistance and training programs, we support your career advancement.
  • Tax Savings! Enroll in pre-tax Health or Dependent Care Flexible Spending, HSA with company contributions, parking, and/or transit commuter benefits.
  • Support! Working parents and busy professionals - we've got you covered with a supportive culture, confidential Employee Assistance Program and a membership to Care.com.
  • Perks! Employee discounts, peer recognition programs, company-wide wellness challenges, and fun community events.
  • A Voice! A unique culture where you can influence decisions and have your voice heard.


We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability, or veteran status.