Principal Clinical Data Manager

Location
Rockville, Maryland
Salary
Competitive
Posted
Oct 18, 2020
Closes
Nov 17, 2020
Ref
2635
Function
Management
Industry
Science
Hours
Full Time
The Emmes Company, LLC is searching for a Principal Clinical Data Manager based out of our Rockville, Maryland, Frederick, Maryland and/or Tysons Corner, Virginia office. Emmes provides flexibility for the office location or work remote preference dependent upon position.

The Emmes Company, LLC is a private Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.

Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.

Primary Purpose

The Principal Data Manager provides data management leadership and subject matter expertise for research studies. The Principal Data Manager works as an integral part of a cross-functional team through the lifecycle of the research study from design through final analysis and study closeout. The Principal Clinical Data Manager is responsible for the completeness and accuracy of the study data in the electronic database and serves as an expert consultant to cross-functional internal and external teams on all aspects of data collection and data management best practices .

Responsibilities
  • Serves as lead point of contact for both internal cross functional teams and external contacts on the design, documentation, testing and implementation of clinical data collection studies in an electronic data capture (EDC) system
  • Provides oversight for creation and/or review of study-specific electronic or paper Case Report Forms (CRFs) using strong technical knowledge, protocol-specific information, and departmental standards. Ensures timely development and implementation of CRFs. Serves as project or therapeutic area resource for design and development challenges
  • Provides oversight for determining data collection requirements at a project or therapeutic area level, utilizing extensive system experience to drive development
  • Responsible for analyzing potential complex data management issues/risks and recommending/implementing solutions
  • Approves/reviews clinical data management plans or develops key study document templates (e.g. Data Management Handbook, Data Management Plan, Data Validation Plan, EDC System User's Guide, EDC Training and Certification Documents)
  • Leads data reviews with data management team to ensure accuracy and consistency and creates corrective action plan as necessary
  • Provides oversight of training documentation and system user access, may serve as resource for complex troubleshooting
  • Mentors DM staff in general team leadership skills, project management skills, internal Emmes DM processes, and for project or therapeutic area specific tasks
  • Authors, reviews, and/or edits written summaries of data reports, presents data as applicable
  • Provides oversight for the management and reconciliation processes of the data obtained through Electronic Medical Records (EMR) integration, commercially available EDC systems, or other external data sources
  • May be required to facilitate or present at meetings, conferences, and other events representing Emmes; including job fairs or other external events
  • Develops and implements data validation processes
  • Ensures the integrity of data, providing recommendations for corrective action when necessary.
    • May provide direct line support for DM staff. For direct reports:
    • Collaboratively conducts performance and compensation review activities with the applicable project leader or designee
    • Responsible for addressing employee relations issues and resolving problems
    • Ensures DM salary and bonus equity compliance
    • Approves timesheets, expense reports, and leave requests

Required Experience
  • Bachelor's degree in scientific discipline preferred with a working knowledge of the clinical/scientific terminology and methods; at least 8 years data management experience
  • Preferred Master's in scientific discipline accompanied with basic understanding of the clinical development and data management processes with 6 years progressive experience working in a clinical research environment

Required Skills/Abilities
  • Knowledge of MS Excel, Word, Access, and PowerPoint
  • Good analytical, interpersonal, and organizational skills
  • Excellent verbal and communication skills
  • Must have a good understanding of clinical database structures, and data management processes
  • Strong attention to detail and flexible

CONNECT WITH US!!

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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

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