Clinical Study Manager - PGxHealth

Position Description

SUMMARY
This position is part of the Medical Affairs team and reports to the Senior Medical Research Manager. Responsible for managing the conduct of clinical trials and associated activities related to PGxHealth’s Phase III investigational product in development for the treatment of depression and clinical trials for the development of pharmacogenetic tests:



ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
• Organizing, planning, and conducting clinical trials which may or may not be conducted by a CRO.
• Responsible for overseeing multiple Phase 1 clinical trials. This is to include assuring timelines and deliverables are met by the CRO and other team members.
• Monitors adherence to protocols by conducting ongoing reviews of data collected by the investigational sites via a Remote Data Entry System or other means of data review (e.g. site visits, faxing etc.). Conducting quality checks on the information provided by the CRO.
• Tracks Serious Adverse Event documentation and follow-up
• Conducts and documents co-monitoring visits with CRO personnel
• Conducts and documents site file audits (internal) and investigational site audits (external)


SUPERVISORY RESPONSIBILITIES

Position has no supervisory responsibilities.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

Bachelor’s degree (B. A.) from four-year college or university; a minimum of three years related experience and/or training working in a CRO or pharmaceutical company. Experience managing Phase 1 trials considered a preferred but not required. Successful candidate must have experience in clinical study management.






LANGUAGE SKILLS

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.


MATHEMATICAL SKILLS

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.


REASONING ABILITY

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

CERTIFICATES, LICENSES, REGISTRATIONS

None

PHYSICAL DEMANDS

None

How to Apply

Application Instructions / Send a Resume