Clinical Data Manager

Location
Bethesda, MD, US
Posted
Feb 11, 2021
Ref
2020-4182
Discipline
Clinical, Clinical Data
Hotbed
BioCapital
Required Education
Masters Degree/MBA
Position Type
Full time
Overview

Medical Science & Computing (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.

Duties & Responsibilities

  • 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

  • Bachelor's degree in Life Sciences, Computer Science or a related scientific field required. Master's 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.


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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 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.