Clinical Scientist/Manager

Hurley Consulting Associates is seeking a Clinical Scientist/Manager to join our Development  group. A Bachelors/M.S., or R.N with a minimum of 5 years pharmaceutical industry or related field is required.  The successful candidate must have excellent written and oral communication skills, have a working knowledge of FDA clinical  regulatory and compliance requirements, and have experience in clinical trial planning, study conduct, site monitoring, and project management.  The main focus of this position is to support the planning and assessment of clinical trial data and the preparation of documentation required to support IND, NDA, and BLA applications.    

The responsibilities include:

• Review of clinical data, reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, and data management plan
• Contribute to the design, central monitoring, and reporting of clinical studies performed by clients or by CROs
• Draft written summaries for regulatory submissions including INDs, NDAs, and BLAs
• Create and maintain project plans
• Participate in cross-functional teams and provide support to others in the preparation, analysis, and documentation of studies

Hurley Consulting Associates Ltd. offers a competitive salary, health care benefits, group life insurance, and a 401(k) plan.