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clinical research in Chicago

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  1. Senior Clinical Research Associate

    We are looking for a Midwest CRA with Oncology and Infectious disease.  Must have both therapeutic areas to be considered.   Responsibilities: MONITORING – Preparation, conduct, and reporting of selection, initiation/startup, routine/interim and closeout monitoring visits, Site management, Assistance at internal and third-party audits).  Assures timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviations.  Maintains regular review of site regulatory binder and ...

  2. Senior Medical Writer (home based)

      Regulatory Medical Writer Must have written all of the following: NDA submissions, Protocols, Narratives, Case Report Studies, and Inform Consent forms   Write clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical ...

  3. Vice President of Quality

    JOB SUMMARY: We are just beginning a search for a Vice President of Quality (US Operations).  Our client is a leading global health care company that focuses on medicines and medical devices used to care for critically and chronically ill patients.  Our products include intravenous specialty and generic medicines, infusion therapies, blood-transfusion technologies and clinical nutrition.   The VP of Quality is responsible to assure that all activities associated with development, non-clinical and ...

  4. Clinical Medical Director

      - Looking for someone with Industry experiencing in actively running trials. - An MD is preferred. - Presumably someone with trial experience has the capability to triage SAEs. - TA is immunology and is highly preferred. - Board certification is not mandatory.   Additional:   Provide medical leadership and strategic clinical program direction for the development of 4-5 indications in one or more new drug candidate programs. The Medical Director assumes a leadership role in progressing ...

  5. Senior Clinical Research Associate

    We are looking for a Midwest CRA with Oncology and Infectious disease.  Must have both therapeutic areas to be considered.   Responsibilities: MONITORING – Preparation, conduct, and reporting of selection, initiation/startup, routine/interim and closeout monitoring visits, Site management, Assistance at internal and third-party audits).  Assures timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviations.  Maintains regular review of site regulatory binder and ...

  6. Clinical Research Management Associate

    Assist Study Project Manager (SPM) for one or more clinical studies.  Assist with management of Study Monitoring and Management (SM&M) and suppliers, such as CROs and Central Labs.  Maxtrix management of functional area leads to meet study deliverables.  Be aware of both internal and external business environments and their impact on studies.  Escalate performance issues to management. Assist SPM in the coordination of activities of cross-functional areas for the initiation, conduct and completion ...

  7. Clinical Research Manager Associate - Permanent / Fulltime

    Clinical Research Manager Associate   • Minimum of 3+ years of CRA experience or 3+ years related experience. • Strong site management and monitoring skills • Experience in multi-therapeutic areas desired • Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials. • Excellent knowledge of regulations governing clinical research, ICH/GCP Guidelines and/or federal regulations, and applicable local regulations. • ...

  8. Product Manager - New Drug Launch - Relocation to RTP, NC

    Precept Life Sciencs is hiring a Product Manager to work with our pharmaceutical client in Research Triangle Park, NC. The ideal candidate will manage the product launch of a new respiratory drug. **Relocation assistance available**   Major Accountabilities / Responsibilities: Assist in the development of brand strategy, tactical plans, and budget. Gather and analyze insights from inside and outside of the organization. Participate in the creation of annual brand plans and tactical plans. ...

  9. Clinical Project & Operations Manager - Oncology - Chicago, IL

    Seeking experience with translational medicine, biomarker identification and companion diagnostics in the contect of Cancer therapeutics development to oversee operations and project management for globa pharmaceutical company. Shall manage lab and clinical operataions including following activities: *** Participate in the identification, selection and development of biomarkers and diagnostics for trials. *** Manage, track and coordinate associated regulatory activities as well as lifecycle ...

  10. Senior Director hh

    Senior Director, Regulatory Affairs, Area & Affiliates US & Canada Description Primary Job Function: The function of a Senior Director Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Additionally, the individual may develop and supervise regulatory professionals. The individual has division and corporate level influence and is generally considered a key opinion ...