Data Manager/Protocol Monitor
6 days left
- Full Time
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 an experienced Data Manager/Protocol Monitor
This position will support a Clinical Trial Coordinating Center study, which has responsibility for protocol development, data systems development/maintenance, data management, site monitoring, medical monitoring, Data Safety and Monitoring Board (DSMB) management and biostatistical services for clinical trials.
The study sponsor is a leader in the development of cellular and immune therapeutics, committed to changing the treatment paradigm for patients with cancer and rare genetic diseases. The lead clinical program has received U.S. Breakthrough Therapy Designation and is currently in phase 3 clinical testing as a universal bone marrow transplant solution for patients unable to find a suitable matched donor. In pilot and phase 1/2 studies, it has achieved the first evidence of an ex vivo expanded graft providing a rapid and robust hematopoietic recovery following infusion.
- Work in a multidisciplinary project team environment to provide clinical trial support throughout the lifecycle of the clinical study, from study design through final analysis
- Critically review and comment on study protocols, informed consents and other study documents as needed
- Assist the Project Manager with site start up activities
- Assist project staff in tracking that essential documents are received and maintained across assigned studies and sites
- Assist in the training of new site staff on trial procedures and data system use
- Track and document training of Emmes staff as well as key site staff
- Collaborate with internal and external team members to improve study conduct
- Participate on conference calls with study team offering input as appropriate
- Prepare meeting minutes for team calls
- Review site visit reports prepared by CRAs for site or study wide issues
- Prepare summary reports of outstanding issues and Investigator File verification needs for CRAs prior to site visits
- Ensure adherence to project and corporate standard operating procedures (SOPs), as well as Federal Regulations and ICH/GCP in maintaining
- Develop, generate, manage, and distribute data queries and reports to clinical sites
- Contribute to electronic case report form (eCRF) and data system build and validation as needed
Bachelor’s degree in a scientific discipline preferred
- 2 years of experience, preferably in clinical research
- Skills in prioritization, problem solving, organization, decision making, time management and planning
- Ability to function effectively on a team, providing and receiving constructive feedback
- Prior knowledge of GCP, HSP and regulatory guidelines and regulations helpful 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 Data management/computer skills; experience with CRF design, EDC systems, or other web based data collection systems helpful
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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.