Lead CRA / Study Manager (50% travel), Phase II (Infectious Disease/Immunology) – RTP, NC BioPharma – Local Candidates Only
Our client, an RTP-area Biopharmaceutical company with products in the infectious disease space, is actively recruiting for a highly capable Lead CRA / Study Manager to join its R&D team.
This company is building. This CSM will drive its leading clinical development program, with particular focus on Phase II trials. The selected candidate with be involved in site identification and study set up of a national phase II trial. Duties will include oversight of the study design and reporting, document design, vendor selection and oversight, as well as investigator selection, study conduct, site monitoring, data collection, clinical supplies and study budget development and tracking.
This role is based in the Raleigh, NC area and we seek a candidate able to go onsite several days a week as needed. Travel is estimated at 50-60%.
We seek a versatile and “can do” Lead CRA / Study Manager whose clinical research knowledge is complemented by practiced and proven project management capabilities. A lot is happening and we seek a candidate who thrives in a “hub” role.
Specific duties will include:
- Site identification and study set up
- Oversee and manage vendors (CRO, CRAs, central laboratory, IXRS, etc.), as well as review and approve invoices
- Contribute to Clinical Development plans and budgets
- Coordinate and manage production of key deliverables for clinical trials, including protocols, case report forms, statistical analysis plans, data management plans and clinical study reports
- Ensure monitoring visits and reports are meeting clinical monitoring plan expectations
- Ensure regulatory documents and monitoring reports tracking/submissions are kept up to date
- Generate and/or review study plans and documents
- Ensure supplies are maintained at sites
Ideal candidate will offer a related degree (BS expected) and 5+ years of Lead CRA / clinical study management / coordination experience including site, CRO and study oversight. Experience monitoring and managing Phase II clinical studies will be required. Experience with respiratory infectious disease or immunology trials is a strong plus. Pharma side and small company experience is strongly preferred.
In addition, we seek a very sharp, knowledgeable and organized professional who will work exceedingly well in a dynamic and collaborative setting; One who can gain the respect and cooperation of all stakeholders in order to achieve shared success.
This is an immediate need. Please forward Word resume for prompt consideration. Local candidates only.