Head of Clinical Operations
ProClinical is currently seeking a Head of Clinical Operations for a biopharmaceutical company located in New York. Successful candidate will be responsible for designing and leading clinical operations initiatives across projects as well as manage external contractors and CROs.
- Studying management of clinical trials of hematology, oncology development candidates.
- Managing cross functional leadership and CRO/vendor management related to clinical trial operations aspects.
- Leading the selection and oversight of CROs and other vendors.
- Developing and leading the review of clinical outsourcing strategies and plans.
- Managing assigned clinical trial budgets.
- Representing Clinical Operations on cross-functional project teams and Vendor/CRO operational meetings and ensuring compliance with operational standards and procedures.
- Initiating and lead monitoring oversight activities in accordance to ICH/GCP standards.
- Representing the Company externally to Investigators and trial site administrators.
- Overseeing activities leading to internal GCP audits and regulatory inspections related to clinical trial conduct.
- Developing and maintaining strong, collaborating with key stakeholders within the company.
Skills and Requirements:
- 10-15+ years of global trial management experience in a clinical research environment, most of which should be in industry and in Hematology/Oncology.
- Strong experience in hematology indications preferred.
- MS/PhD preferred or BS in a science-based subject required.
- Thorough experience in early phase drug development and proven track record of success.
- Multi-dimensional Clinical operations background with capability of devising plans for operational challenges such as site activation, patient enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.
- Proficient in engaging with cross-functional teams such as Research, Drug Supply, and Finance.
- Thorough command of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States, Europe and rest of world.
- Outstanding verbal and written communication skills including clinical authoring experience including protocols and investigator brochures.
- Experience in establishing and maintaining relationships with key opinion leaders.
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 Miles Tobin at (+1) 617-545-5922 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.
£0.00 - £100000.00 per annum
Worthing, West Sussex
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