Clinical Data Manager

Location
Rockville, Maryland
Posted
Jul 24, 2021
Ref
2021-10209
Hotbed
BioCapital
Required Education
Doctorate/PHD/MD
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
  • Oversee sponsor Clinical Data Management activities for the adaptive platform trial, ACTIV-2.
  • Work collaboratively across multiple cross functional groups including Clinical Trial Managers (CTM’s), Biostatistics and Clinical Data Management vendors to ensure database development, data review/cleaning, database auditing, database lock, and receipt of final database deliverables are in compliance with standard operating procedures and regulatory agency guidelines.
  • Provide technical oversight of service providers performing core data management functions including CRF/edit check development, user acceptance testing (UAT), integrated response technology (IRT), biostatistics, data cleaning, listings review, and database lock procedures.
  • Responsible for the oversight of clinical data management study deliverables, evaluates and mitigates data management-related risks across functional areas of ACTIV-2 on behalf of the trial sponsor.
  • Conduct reviews of oversight related data, operations-related trend analyses, and performs report reviews.
  • Review the development of database specifications, validation plans, and data management plans, ensuring alignment with case report forms, protocol, and safety data standards.
  • Responsible for overseeing the end-to-end data management study related activities in terms of quality and delivery according to plan on a day-to-day basis.
  • Provide oversight for data management activities, including: Implementation of data management aspects of ACTIV-2 and data collection systems; Strategic input into mitigation of potential data management issues; Review data management activities and recommend process improvements; Maintain high-level oversight on data quality metrics and data management deliverables.

#LI-DD1

Requirements
  • Master’s Degree in clinical, biological, mathematical or computer science subject.
  • Minimum ten (10) years of experience in clinical data management.
  • Experience with developing and managing clinical trial databases and data management/collection systems.
  • Familiarity with user testing, integrated response technology (IRT), and biostatistics useful.
  • Experience with extensive data reporting, data specifications, validations and data planning.
  • Project management experience or experience managing timelines highly desired.
  • Strong verbal and written communication skills.

 

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.