Job Listing: Clinical Study Manager

Our client, a biopharmaceutical company that utilizes its expertise and established infrastructure to discover genetic markers and in-license others that form the foundation of genetic testes, is looking for a Clinical Study Manager to join their team.

The Clinical Study Manager will report to the Sr. Medical Research Manager and is responsible for managing the conduct of clinical trials and associate activities related to Phase I investigational products in development for the treatment of depression and clinical trials for the development of pharmacogenetic tests. On a daily basis, the Clinical Study Manager will perform the following functions:
- 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)

To be qualified for the Clinical Study Manager position, individuals MUST have the following qualifications:
- 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

Required Skills for Clinical Study Manager Job:

About Aerotek Scientific:

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.