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drug safety in Raleigh

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  1. Senior Project Manager

     Note: Candidates must possess Ph. 1 and 2 Full Service Oncology PM Experience ~~SUMMARY: The Clinical Operations Senior Project Manager (SPM) is responsible for overall management of all phases of clinical trials, from start-up through completion of activities, utilizing MedSource or sponsor Standard Operating Procedures (as applicable), FDA regulations, and ICH-GCP guidelines.  In-depth knowledge and experience of the drug development process is required, including study initiation, clinical ...

  2. Clinical Document Specialist

      ~~SUMMARY: • The CDS will support the Company’s regulatory function and study team in the document management of clinical research trials from the project development stage through to project completion.  Mainly, the CDS will perform a variety of research, database, and administrative duties of a routine and technical nature in support of clinical trials to assist investigators in organizing, gathering, and compiling clinical research data. DUTIES AND RESPONSIBILITIES: • Assist with collecting, ...

  3. Regulatory Affairs Specialist

    ~~SUMMARY: • The Regulatory Affairs Specialist supports the Company’s regulatory function and project teams through the provision of a variety of administrative and technical tasks involving the management of clinical research trials documentation. In addition, the Regulatory Affairs Specialist performs a variety of research, database, and administrative duties of a routine and technical nature in support of corporate initiatives and clinical trials to assist MedSource and/or clients in organizing, ...

  4. Drug Safety Analyst

     Precept Life Sciences is currently seeking a Drug Safety Analyst for our client, an established and growing biotech company, located in Raleigh, NC. This is an exciting opportunity for candidates that have a strong background in Drug Safety and Reporting to take their career to the next level while working for a top rated company. The Drug Safety Analyst will be responsible for providing report generation and serving as a technology expert for third parties / vendors. Candidates should have a very ...