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Clinical Research Scientist

Lancesoft Inc.
Woodcliff Lake, New Jersey, United States
February 06, 2017


The incumbent is responsible for, but not limited to the following:

• Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies

• Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, ISE, Investigator Brochure, etc)

• Performs literature search and data analysis to address research questions

• In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.)

• Assisting in database cleaning, review of study results, and interpretation of results

• Adhering to key performance indicators for clinical study development, conduct, and reporting

• Individual contributor with specialized knowledge

• Presents concepts, facts, and reports and advises on key trends and issues

• Troubleshooting routine site inquiries

• Work is completed under limited supervision

• Supports the planning, execution and reporting of clinical programs/trials

• May handle multiple protocols simultaneously

• Contributes to risk resolution by escalating and monitoring project risks

• Minimum of 5-7 years of experience in clinical research in the pharmaceutical industry

• A thorough understanding of clinical research methodology including study design, protocol writing, and CRF preparation is required, as is a knowledge of GCP and local regulatory requirements

• Working knowledge of the IND/NDA/CTD/MAA process acquired through direct industrial experience preferred

• Knowledge of medical, scientific and clinical research techniques in the oncology therapeutic area;

• Bachelor’s Required. Doctoral (PharmD or PhD) degree preferred