Career Opportunity: Clinical Research Manager
The Clinical Research Manager (CRM) will directly report to the Vice President, Clinical and will be responsible for supervising, monitoring, and supporting the execution and progress of multiple clinical trials, ranging from exploratory to Phase III, conducted by Zynerba Pharmaceuticals (Zynerba). The CRM will be responsible for developing protocols, overseeing conduct of the study(ies) to ensure project quality and adherence to Good Clinical Practice Standards, interacting closely with multiple investigators across and outside the U.S., helping to solve issues that arise in the implementation and conduct of clinical studies, managing one or more Contract Research Organizations (CROs) utilized in the implementation of a clinical study, and ensuring completion of studies on time and on budget. This position will be office-based in our Devon, Pennsylvania office.
- Assist the clinical team in the implementation of clinical projects by gathering information concerning the therapeutic area under investigation.
- Prepare and/or review protocol synopses, protocols and protocol amendments.
- Prepare study specific case report forms and source documents.
- Conduct study monitor and investigator training.
- Interact with investigators/study site personnel to resolve issues.
- Interview and assess capabilities of CROs and service vendors for specific clinical studies.
- Assist with the negotiation of contracts with CROs and investigators.
- Manage the activities of selected CRO(s) to ensure successful execution and completion of clinical trial activities.
- Manage the study budgets for CROs, investigator grants and other vendors, as applicable.
- Identify investigators and assess their suitability for participation in a Zynerba study.
- Interact with the Data Management, Biostatistics and IWRS companies and any other service providers applicable to managing the clinical study.
- Attend investigator meetings; if appropriate, attend pre-study qualification, initiation, monitoring and close-out visits with CRO CRA staff. Ensure that CRO documents all activities via memos, trip reports and trial management tracking reports.
- Conduct quality and safety review (under supervision of Medical Monitor) of completed CRFs to ensure appropriate reporting of adverse events and adherence to the protocol.
- Review the issued Clinical Study Report for a clinical study and provide information as needed.
- This position requires a minimum of a Bachelor’s Degree in a scientific discipline or pharmacy, BSN degree, and experience managing clinical trials as a Clinical Research Lead.
- Approximately 30% overnight travel, based on study demands, is required. Some international travel may be required.
- Must have a good working knowledge of GCP/ICH Guidelines and all monitoring responsibilities.
- Formal certification as a Certified Clinical Research Associate (CCRA) and previous project management experience is highly desirable.
- Must possess the ability to work closely with all disciplines within a small company. Effective written communication skills and computer skills are required.
- Must be able to work with minimal direction, be able to prioritize, and be capable of handling multiple assignments.
- Strong computer skills, MS Word, Excel, Outlook, MS Project and PowerPoint.
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