Clinical Data Manager

Location
Rockville, Maryland
Posted
Jul 15, 2021
Ref
2021-10434
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time

We are currently searching for a Clinical Data Manager 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
  • Serve as a subject matter expert for the legacy clinical data management system and form designer.
  • Function in a collaborative role to support clinical research data management services and develop standard templates for clinical trials and observational studies.
  • Develop standard databases and forms for the NIAID DataFax (DFdiscover) system and in supporting tools.
  • Design forms for collection of data requires expertise using legacy versions of Adobe FrameMaker and a familiarity with clinical research data points and terminology forms and database using CDISC standards.
  • Ensure the integrity, maintenance, and on-going support of the DataFax/DFdiscover system, Adobe FrameMaker, and SharePoint for document repositories.

 

Requirements
  • Bachelor’s Degree in Life Science, Computer Science or any other related field(s).
  • Minimum of ten (10) years of experience working with DataFax/DFdiscover (prior to 2018 the application was DataFax) is required.
  • Minimum of seven (7) years of experience with Adobe FrameMaker to ensure skills using older versions and converting the legacy FrameMaker files to the latest versions is required.
  • Facility experience with study table structures and variable names using major domains and control terminology in Clinical Data Interchange Standards Consortium (CDISC), particularly Study Data Tabulation Model (SDTM) and Clinical Data Acquisition Standards Harmonization (CDASH) is required.
  • General understanding of FDA 21CFRPart11, Good Clinical Data Management Practices, and Good Clinical Practices is required.
  • Ability to read clinical protocols for trials or observational studies.
  • Prefer to have working proficiency in French language – verbal and written.
  • Experience with the management and provisioning of sites, lists, tables, document repositories, and site collections, in particular management of user permissions, in Microsoft SharePoint server environments is required.
  • Demonstrated understanding of the roles and authorizations for support and management of clinical data is required.

 

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.