Clinical Research Project Manager
The EMMES Corporation, organized in 1977, is a privately owned Contract Research Organization (CRO). Emmes is dedicated to providing statistical and epidemiological expertise, computer systems development, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in clinical and biomedical research. Emmes is seeking a Clinical Research Project Manager to support all phases of clinical trials.
- Coordinate the activities and supervise the project study team
- Liaison with the study sponsors and the collaborating investigators to prepare and initiate clinical protocols
- 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
- Minimum of a bachelor’s degree and a background in public health, biological sciences or related fields
- 5-10+ years of experience in clinical trials with a solid understanding of clinical trial databases
- Proven supervisory skills and excellent verbal and written communication skills
- Infectious disease knowledge and FDA-related experience a plus
- SAS proficiency, familiarity with CDISC, and experience with site monitoring, training and selection a definite plus
Emmes has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs.
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Emmes is proud to be an Equal Opportunity Employer. EOE/M/F/D/V