Theradex is a leading global oncology CRO in business for over 35 years is seeking a Pharmacovigilance (Drug Safety) Associate for our US headquarters based in Princeton, NJ. Serving the pharmaceutical and biotechnology industry and specializing in oncology, we are valued for quality monitoring, strong clinical expertise, and client satisfaction.
As part of our drug safety team, you’ll have the opportunity to be part of a collaborative and supportive environment. If oncology is your passion, Theradex is the place to develop your career while helping us in our mission to cure cancer.
What you’ll do:
The primary responsibilities of this position include, but are not limited to, the following:
Implement Safety Management Plans (SMP) specific for the study protocol and Sponsor requirements.
Manages the receipt and processing of SAE reports according to the Safety Management Plan, or equivalent document. This includes but is not limited to:
Reviews SAE reports and any...
Oct 21, 2020
Full time
Theradex is a leading global oncology CRO in business for over 35 years is seeking a Pharmacovigilance (Drug Safety) Associate for our US headquarters based in Princeton, NJ. Serving the pharmaceutical and biotechnology industry and specializing in oncology, we are valued for quality monitoring, strong clinical expertise, and client satisfaction.
As part of our drug safety team, you’ll have the opportunity to be part of a collaborative and supportive environment. If oncology is your passion, Theradex is the place to develop your career while helping us in our mission to cure cancer.
What you’ll do:
The primary responsibilities of this position include, but are not limited to, the following:
Implement Safety Management Plans (SMP) specific for the study protocol and Sponsor requirements.
Manages the receipt and processing of SAE reports according to the Safety Management Plan, or equivalent document. This includes but is not limited to:
Reviews SAE reports and any...
We have a six-month temporary Data Management Coordinator to work at our US headquarters in Princeton, NJ. This entry level position has the potential to go from a temporary to a full-time regular position.
What you’ll do:
The primary responsibilities of this position include, but are not limited to, the following:
Review incoming data for completeness, accuracy, patient eligibility, and protocol compliance in Rave® EDC; clinically review patient data; write and resolve data queries; assist site personnel with case report form and query completion; contact sites as needed; follow up on serious adverse event discrepancies.
Prepare SAE and query summary reports for the CRAs prior to site visits. Review data audit discrepancies provided by CRAs following site visits prior to submitting visit report to sponsor.
Assist in preparation of eligibility checklists, protocol abstracts, and protocol code lists as required for new or amended CTMS monitored...
Oct 21, 2020
Full time
We have a six-month temporary Data Management Coordinator to work at our US headquarters in Princeton, NJ. This entry level position has the potential to go from a temporary to a full-time regular position.
What you’ll do:
The primary responsibilities of this position include, but are not limited to, the following:
Review incoming data for completeness, accuracy, patient eligibility, and protocol compliance in Rave® EDC; clinically review patient data; write and resolve data queries; assist site personnel with case report form and query completion; contact sites as needed; follow up on serious adverse event discrepancies.
Prepare SAE and query summary reports for the CRAs prior to site visits. Review data audit discrepancies provided by CRAs following site visits prior to submitting visit report to sponsor.
Assist in preparation of eligibility checklists, protocol abstracts, and protocol code lists as required for new or amended CTMS monitored...
