1+ months

Clinical Data Manager

MSC
Bethesda, MD 20814

Overview

We blend deep domain expertise in health IT, life sciences, public safety, and grants management with advanced technologies to help Federal agencies 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 cultivate a culture of innovation, customer success, and employee growth.

Duties & Responsibilities

MSC is 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 Bethesda, Maryland.

 

  • Oversee sponsor Clinical Data Management project timelines on multiple complex studies or programs.
  • Provide technical oversight of service providers performing core data management functions including CRF/edit check development, user acceptance testing, data cleaning, listings review, and database lock procedures.
  • Responsible for the oversight of clinical data management study deliverables, evaluates and mitigates risks across programs on behalf of the Division.
  • Conduct data reviews.
  • Review the development of database specifications, validation plans, and data management plans; ensuring alignment with case report forms, protocol, and safety data standards.
  • Lead and participate in cross-functional data management-related process initiatives on behalf of the Division.
  • Responsible for overseeing the end to end data management study related activities on a day to day basis, and is the ultimate accountable person for the data management study deliverables in terms of quality and delivery according to plan.
  • Provide oversight for data management activities, including: a) implementation of data management aspects of clinical protocols and data collection systems; b) strategic input into proposal or protocol design focused on data management considerations; c) mitigation of potential data management issues by reviewing protocols for cross-project consistency and identifying standard case report form modules to meet objectives; d) reviewing data management activities and recommending process improvements; and e) maintaining high-level oversight on data quality metrics and data management deliverables.

Requirements

  • Bachelors degree in Life Sciences, Computer Science or a related scientific field required. Masters degree, Certified Clinical Data Manager (CCDM) or related graduate certification preferred.
  • At least five (5) years of clinical data management experience is required.
  • Pharmaceutical experience is required.
  • Experience managing clinical study data using Electronic Data Capture (EDC) software.
  • Prior experience in database development required.
  • Experienced in developing study documents, specifically case report forms (CRFs), edit check specifications and data management platforms (DMPs).
  • Familiar with the multiple phases of clinical trial development. Knowledge of GCP, ICH and FDA regulations and guidelines a plus.
  • Excellent computer skills and proficient in Microsoft Office Suite and Adobe products. Experience with statistical software a plus.
  • Strong verbal and written communication skills. Demonstrated ability to communicate with non-data focused people is a plus.

 

 

Medical Science & Computing (MSC), a Dovel company, is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Categories

Posted: 2020-09-22 Expires: 2020-11-21

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Clinical Data Manager

MSC
Bethesda, MD 20814

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