Data Manager (Experienced)

Location
Rockville, Maryland
Posted
Apr 05, 2019
Closes
Apr 05, 2019
Function
Management
Industry
Science
Hours
Full Time

The EMMES Corporation, established in 1977, is a woman-owned, private Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, 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 offer statistical support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation. Emmes is seeking a Senior Data Manager.

Project

This position will support The National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) research team that provides data management and statistical support for clinical studies. The NIDA CTN is a national network of research sites conducting studies of behavioral, pharmacological, and integrated treatment interventions in rigorous, multi-site clinical trials. The objective is to “bridge the gap” between science and practice. The NIDA CTN is comprised of 13 Nodes, associated with approximately 240 Sites. Primary services that the DSC provides for the NIDA CTN include developing and maintaining an electronic data capture system, designing and performing statistical analyses, monitoring the quality of study data and the progress of the study, preparing study reports, assisting in protocol development, and assisting in the reporting of study findings.

Congress has recently allocated funding towards the HEAL (Helping to End Addiction Long-term) Initiative, an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. A large portion of the funds have been allocated to NIDA and the CTN in particular. With this increase, our project will have the opportunity to play an important role in advancing this research to combat the opioid crisis and develop more customized, high-quality treatments for addiction and pain, as well as harness implementation science to bring evidence-based changes to our healthcare system. More information about the NIDA CTN can be found here: http://www.nida.nih.gov/CTN/Index.htm

A Senior Data Manager works as an integral part of a multidisciplinary team to ensure that timelines are met and deliverables are of high quality throughout the lifecycle of their protocol(s), from development through final reporting. An experienced Data Manager will quickly learn Emmes’ proprietary systems for eCRF development and query generation, and is also expected to work independently to develop data collection forms based on the protocol, draft study documents, and coordinate study report generation. The DM is responsible for the completeness and accuracy of the study data in the electronic database and works closely with site staff to achieve this. Data management deliverables include sections of the protocol, electronic case report forms, functional requirements, data integrity checks, manuals of procedures, user’s guides, data collection guidelines, and materials for their protocol(s)’ Data Management meeting. The DM also performs quality control of study-specific reports.

Responsibilities

  • Critically review and comment on study Protocol, Manual of Procedures, and eCRFs and other study documents as needed
  • Collaborate with internal and external team members to improve study conduct, monitoring and assure compliance with study procedures
  • Develop rapport and strong, productive relationships with NIDA contacts and protocol operations team
  • Willing and eager to seek out creative and innovative resolutions to issues or problems and think strategically
  • Participate as a team leader in protocol planning, implementation, and problem solving
  • Mentor project junior DM staff
  • Assist in the planning, monitoring, and coordination of clinical research studies at external sites by facilitating effective communications (oral and written) with internal and external project team members, site study coordinators and investigators, and the study sponsor to ensure compliance with protocol and overall clinical objectives
  • Provide critical review of study materials, including the study protocol, manual of procedures, User’s Guide, CRF Completion guidelines, practica, and functional requirements
  • Work in a team environment to oversee and contribute to the design, development, validation and management of electronic case report forms and the clinical trial data systems, utilizing strong data management and computing skills
  • Develop, generate, manage, and distribute data queries and reports to clinical sites
  • Ensure adherence to project and corporate standard operating procedures (SOPs), as well as federal and ICH guidelines in maintaining data integrity and quality throughout a clinical study
Experience

    Bachelor’s degree in a scientific discipline or equivalent experience Minimum 3 years of experience in clinical research, including data management experience Strong data management/computer skills; experience with CRF design, EDC systems, or other web-based data collection systems Strong attention to detail required Excellent oral and written communication skills with the ability to effectively communicate and coordinate with internal and external clients and colleagues Personable and able to work well as part of a team Interpersonal skills with a capacity and desire to mentor project DMs a plus Strong skills in prioritization, critical thinking, problem solving, organization, decision making, time management and planning Prior experience in substance use disorder or mental health research preferred
Emmes has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs

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The EMMES Corporation 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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