Clinical Research:
Medical Director
Designs, implements and monitors clinical
studies of compounds designated for clinical development. Develops
protocols and case report forms,
which will provide adequate efficacy and safety information for Phases
1 to 3 of clinical trials. Interacts with data management personnel
to plan data entry and analysis; recruits/screens/selects competent
investigators; organizes investigators' meetings; assures that Good
Clinical Practices (GCPs) are followed; assures timely completion
of studies; monitors data for safety and efficacy trends by reviewing
clinical data; and writes clinical reports upon completion or termination
of studies (in cooperation with statistical staff). Reviews requests
for results of Investigational New Drugs (IND) studies, and provides
input for pharmacokinetics and pre-clinical studies. Prepares clinical
portions of INDs, New Drug Applications (NDAs) and Biological License
Applications (BLAs), including protocols, investigator brochures,
medical
reports, efficacy and safety summaries, scientific rationales and
benefit/risk ratios.
Medical Directors require a MD/PhD in a relevant
scientific discipline and a minimum of 5-8 years' experience in clinical
research. Associate
Medical Directors require a MD/PhD and 0-3 years' clinical research
experience. Pharmaceutical experience is desirable.
Approximate
Medical Director Salary Range $150,000 - $240,000
Approximate Associate Medical Director Salary Range $125,000 - $165,000
Clinical Research Manager
Supervises design and writing of protocols, case report forms and informed
consent forms for clinical trials. Supervises and directs the design,
implementation and monitoring of clinical trials, preparation of integrated
medical reports, INDs, Investigational Device Exemptions (IDE), periodic
reports New Drug Applications (NDAs) and Biological License Applications
(BLAs), etc. Makes decisions on recruitment/selection of new investigators,
contract research organizations and outside vendors. Directs planning
and implements all activities required to conduct and monitor complex
clinical trials and ensures that Good Clinical Practices (GCP) are followed.
Monitors site visits pre-study, at study initiation, at regular intervals
during the study and at study closeout. Directs investigator performance
and adherence to protocol, and proactively addresses conduct issues and
enrollment problems, as necessary. Ensures that Case Report Forms (CRF)
are reviewed in a timely fashion and submitted to the data management
group. Monitors the compilation/writing of integrated medical reports
and clinical sections of INDs, IDEs, New Drug Applications (NDAs) and
Biological License Applications (BLAs), etc.
Requires a BS or MS in a
scientific or health care field (e.g., nursing, pharmacy, physician's
assistant) and 5-8 years plus experience in the
pharmaceutical or device industry including relevant clinical research
experience.
Approximate Salary Range $75,000 - $110,000
Clinical Research Manager
Supervises design and writing of protocols,
case report forms and informed consent forms for clinical trials. Supervises
and directs the design,
implementation and monitoring of clinical trials, preparation of
integrated medical reports, INDs, Investigational Device Exemptions (IDE),
periodic
reports New Drug Applications (NDAs) and Biological License Applications
(BLAs), etc. Makes decisions on recruitment/selection of new investigators,
contract research organizations and outside vendors. Directs planning
and implements all activities required to conduct and monitor complex
clinical trials and ensures that Good Clinical Practices (GCP) are
followed. Monitors site visits pre-study, at study initiation, at
regular intervals during the study and at study closeout.
Requires a BS
or MS in a scientific or health care field (e.g., nursing, pharmacy,
physician's assistant) and 5-8 years plus experience in the
pharmaceutical or device industry including relevant clinical research
experience.
Approximate Salary Range $75,000 - $110,000
Quality Control:
Quality Control (QC) Manager/Supervisor
Supervises the development, implementation and maintenance
of quality control systems and activities. Oversees development and
implementation of standards, methods and procedures for inspecting,
testing and evaluating the precision, accuracy, efficacy and reliability
of products.
Coordinates interdepartmental activities. Develops
budgets and monitor expenditures. Provides guidance to employees and
supervises the work group. Responsible for regulatory inspections
and findings including all follow-up.
Requires BS/MS in a related discipline or equivalent
and a minimum of 3-5 years' experience with documentation and implementation
of quality control systems.
Approximate QC Supervisor Salary Range $47,000 -
$65,000
Approximate QC Manager Salary Range $67,000 - $90,000
Quality Control (QC) Analyst
Conducts routine and non-routine analysis of raw
materials, in-process and finished formulations under supervision
and according to Standard Operating Procedures (SOPs).
Compiles data for documentation of test procedures
and prepares reports. Calibrates and maintains lab equipment. Reviews
data obtained for compliance to specifications and reports abnormalities.
Revises and updates SOPs. May perform special projects on analytical
and instrument problem solving.
Requires BS in a scientific discipline or equivalent
and a minimum of 0-4 years' experience. Senior positions require BS/MS
with 3-7 years relevant experience. Previous experience in microbiology,
chemistry or biochemistry is required.
Approximate QC Analyst Salary Range $40,000 - $48,000
Approximate Senior QC Analyst Salary Range $47,000
- $60,000
TOP
