Clinical Study Manager - Oncology
Proclinical is currently recruiting for a Clinical Study Manager of Oncology with a global pharmaceutical company located in Waltham, MA. Successful candidate will be responsible for all processes from initial study request through study close out, including internal review and approval, initial budget assessment, as well as the tracking, close-out, and archival of documentation for approved studies.
- Responsible for all processes from initial study request through study close out, including internal review and approval, initial budget assessment, as well as the tracking, close-out, and archival of documentation for approved studies.
- Focus on one oncology pipeline asset and be the operational contact for both Global and US applicants and the Global Medical Affairs field teams.
- Lead all activities related to managing Oncology Expanded Access Program including status tracking, IP management, safety reporting, drug supply, document management and data review activities in accordance with SOPs and Good Clinical Practice
- Manage vendors associated with EAP programs
- Respond rapidly to requests from physicians regarding patient access to EAP programs
Skills and Requirements:
- BS/RN/RPh degree with 4-5 years of progressive experience in oncology, either in Medical Affairs / Clinical Operations or in oncology hospital (background in life sciences preferred).
- Oncology clinical experience very much desired.
- Experience managing CROs or working in a CRO is required.
- General understanding of oncology research and a desire to expand upon knowledge of pipeline products across multiple disease indications preferred.
- Prior experience with expanded access or clinical research in a study manager or CRA role desired.
- Global experience, particularly in the EU, is preferred but not required.
- Must be responsible for establishing strong partnerships with internal and external teams including physicians, medical directors, MSLs, internal cross functional team members and other partners.
- Experience with compassionate use or Expanded Access programs or clinical operations in biopharma or hospital required.
- Demonstrated knowledge of protocol design in oncology studies.
- Thorough knowledge of FDA, ICH, GCP, and OIG guidelines.
- Strong planning and project management skills.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sarah Beshara at (+1) 267-477-3355 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.