Clinical Scientist

Clinical Scientist

Hurley Consulting Associates Ltd. is seeking a Clinical Scientist to join our Development  group. Pharm D., R.N., or B.A./B.S. with a minimum of 5 to 10 years’ pharmaceutical industry experience including oncology.  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.