Clinical Research Scientist
Proclinical is currently recruiting for a Clinical Research Scientist for a biotechnology company located in New York, NY. Successful candidate will contribute to and/or lead the development of clinical protocols and other clinical documents, in close collaboration with cross-functional team members and external vendors
Skills and Responsibilities:
- Participate in activities related to protocol data review, medical monitoring, query resolution, and study conduct oversight
- Support enrollment projections and assist with the development and implementation of subject recruitment and retention strategies
- Provide scientific review of statistical analysis plans
- Support regulatory activities at the protocol level to develop, prepare and respond to regulatory authorities
- Collaborate on the review, analysis, and interpretation of study results, including exploratory endpoints
- Collaborate with team members in Data Management activities such as development of eCRFs, edit checks, report development and database lock processes
- Assist in writing and providing scientific input, review, and edits of clinical study reports, Investigator Brochures, INDs, NDA annual reports, integrated medical reports, and other regulatory submissions.
- Support preparation of abstracts, manuscripts, presentations, and materials for external meetings as it relates to the assigned protocol(s) and/or clinical program
Skills and Requirements:
- Doctorate degree (e.g. Pharm.D., Ph.D.) with at least 3 years of experience in clinical development in the pharmaceutical/biotech industry, particularly in Phases II-III
- Experience in analysis and interpretation of clinical data (safety and efficacy) and a working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
- Excellent written and oral communication skills
- Ability to multi-task and to work successfully in a lean, fast-paced, matrix team environment
High level of organizational and project management skills.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nicole Aganon at (+1) 347-293-1161 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.