Ruderfer & Associates
Biopharmaceutical Search Consultants

#2087

Associate Director, Clinical Research - Oncology

Position:                      Associate Director, Clinical Research - Oncology        Job #2087

Location:                     Northern NJ

Compensation:          Based Upon Experience

CLICK TO APPLY

Position Summary


The Associate Director, Clinical Research Scientist will assist the Clinical Lead and/or Study Director in the planning and implementation, execution, day to day managing and reporting of clinical trials. Additional responsibilities include: assisting with the preparation of the clinical trial synopses, protocols, protocol amendments, drug development plans, clinical research forms, Investigator Brochure, Clinical Study Report, etc.; training new CRO monitors and CRAs on protocol and processes; assisting with the preparation of the NDA documents; preparing clinical sections of IND annual safety report and annual Investigator brochure updates; assist with the database cleaning (eligibility listings, patient profiles, listings, laboratory results, etc.); and assisting with the preparation of the publications (abstracts, articles, etc.) pertinent to the study.

Responsibilities include but are not limited to:

1. Assisting the Clinical Lead and/or Study Director in the planning and implementation, execution, day to day managing and reporting of clinical trials.

2. Assisting with the preparation of the clinical trial synopses, Protocols, protocol amendments, drug development plans, clinical research forms, Investigator Brochure, Clinical Study Report, etc.

3.Training new CRO monitors and CRAs on protocol and processes

4. Assisting with the preparation of the NDA documents

5 Preparing clinical sections of IND annual safety report and annual Investigator Brochure updates

6. Assisting with the database cleaning (eligibility listings, patient profiles, listings, laboratory results, etc.)

7. Assisting with the preparation of the publications (abstracts, articles, etc.) pertinent to the study

Job Qualifications

• 5 years of experience in clinical research in the pharmaceutical industry

• Requires a Doctoral (PhD or MD) level degree

• 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 process acquired through direct industrial experience is required.

• Knowledge of medical, scientific and clinical research techniques in assigned therapeutic area.

CLICK TO APPLY