Our client, an exciting Biotech Company located in the Cambridge Massachusetts area, is in need of an experienced Manager of Clinical Operations to join their team. If you have ten years of industry experience in project management/clinical operations with strong leadership skills, as well as experience developing/ensuring compliance with SOPs and guidelines, FDA regulations and current ICH GCP guidelines, this could be the perfect opportunity for you!
In this position you will be primarily responsible for all functional activities related to execution of Clinical Trials. You will oversee the implementation of the clinical development plan by managing the timeline, resources and budget of clinical activities. You will oversee CRO and investigator sites, write clinical operation sections of regulatory documents and develop study feasibility/cost estimates for outsourced work. You will develop and ensure compliance with SOPs and guidelines, FDA regulations and current ICH GCP guidelines. You will play a key role in managing trial costs by interfacing with the finance group to provide financial information related to clinical development, as well as interfacing with the legal department to develop improvements to document templates, standard processes and tools.
This position requires a minimum of a BS degree in a life science discipline with a minimum of ten years directly relevant industry experience.
You will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
StratAcuity Scientific, CHEMISTRY IS EVERYTHING.
Compensation: to be determined
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