Senior Data Manager/Protocol Monitor
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 Senior Data Manager/Protocol Monitor
This position will support a pediatric study that is responsible for developing and supporting a comprehensive national research and training effort to increase the knowledge base for understanding how to appropriately treat disease during pregnancy, infancy, and childhood using pharmaceuticals that are appropriately tested within their target populations. These activities are intended to improve pediatric drug therapeutics through preclinical and clinical testing that lead to drug labeling change.
- Coordinate the activities and supervise the project study team
- Liaison with the study sponsors and the collaborating investigators to prepare and initiate clinical protocols
- Utilize project management tools and practices to coordinate the development of new protocols including developing necessary documentation (Operations Manuals, Standard Operating Procedures, etc) in collaboration with protocol team, managing timelines (concept development, initiation, implementation and closeout) and other tasks as needed
- Ongoing review of protocols/consents/IRB submissions
- Oversee and conduct data management and related communication processes for the clinical trials studies
- Work with the study statisticians to prepare statistical and safety reports
- Additional tasks include, but are not limited to, development, review, and approval of protocols, eCRF, study documents, and reports such as SMC, IND and CSR
- Key role as team leader in project planning, implementation, problem solving, tracking milestones and deliverables
- Bachelor’s degree in a scientific discipline or equivalent experience
- Minimum 4-6 years of experience in clinical research
- Knowledge of GCP and HSP regulations
- Strong data management/computer skills; experience with CRF design, EDC systems, or other web based data collection systems helpful Training in and demonstrated understanding of the regulatory obligations of the clinical site monitor, as it relates to site monitoring responsibilities; ACRP CCRA certification is a plus Prior experience in mentoring/training new or junior staff is a plus Excellent oral and written communication skills with the ability to effectively communicate and coordinate with internal and external clients and colleagues Skills in prioritization, problem solving, organization, decision making, time management and planning
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.