Lead Data Manager
The EMMES Corporation, established in 1977, is a privately-owned 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 Lead Data Manager
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. More information about the NIDA CTN can be found here: http://www.nida.nih.gov/CTN/Index.htm
The Lead Data Manager (LDM) serves as a team leader to the project DM staff. The LDM works with the DMs to ensure that timelines are met and deliverables are of high quality throughout the lifecycle of the clinical studies, from protocol development through final reporting. The LDM is instrumental in the review of data management deliverables, including 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 each Data Management meeting. The LDM is responsible for mentoring DMs and is the main resource for problem solving and training. The LDM may serve as the primary DM for one protocol. The LDM is a secondary point of contact with the study sponsor and clinical site investigators.
As the project grows, the Lead Data Manager may become a Project Manager for a portfolio of studies. The LDM will be responsible for developing a timeline and managing deliverable execution against that timeline. He or she will independently review and approve data management deliverables and directly supervise DM(s).
- Participate as a team leader in protocol planning, implementation, and problem solving
- Hire, mentor, train and potentially supervise project 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 and approval 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
- Provide oversight of the development and implementation of a strategy for data cleaning for all protocols
- Review and approve data edit checks and queries produced by the project DM staff. Develop, generate, manage, and distribute data queries and reports to clinical sites for the protocol for which they serve as the DM
- 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
- Lead project standardization and training efforts
Bachelor’s degree in a scientific discipline or equivalent experience
Minimum 4 years of experience in clinical research, including 2 years of 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 strong capacity and desire to mentor project DMs
Strong skills in prioritization, critical thinking, problem solving, organization, decision making, time management and planning
Prior experience in substance use disorder research preferred
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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.