POSITION SUMMARY:
This Senior Manager, Clinical Trial is responsible for managing all aspects of clinical trials to support the development, validation, and commercialization non-invasive molecular diagnostic tests. This role manages clinical operations staff and all aspects of the trials independently, including study design, protocol implementation, site monitoring, and recruitment site management.
PRIMARY RESPONSIBILITIES:
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Responsible for the implementation of clinical trial activities per study protocol. Works closely with investigative site personnel, CROs, and other study vendors
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Manage and coach junior clinical research staff (e.g. CRA, CTA)
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Manage study contracting, budget and payment process for all clinical trial vendors including investigational sites.
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Partner with department head to develop department procedures and develop infrastructure.
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Design study related documents, including but not limited to study protocol, informed consent forms, CRFs, and regulatory binders.
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Train CROs, vendors, investigators and study coordinators on study protocol and relevant
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Monitor and track clinical trial progress and provide status update to stakeholders.
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Partner with other research and development groups to achieve deliverables.
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This role works with PHI on a regular basis both in paper and electronic form and have an access to various technologies to access PHI (paper and electronic) in order to perform the job
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Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
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Must maintain a current status on Natera training requirements.
QUALIFICATIONS:
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Bachelor’s degree in life sciences, other relevant discipline, or equivalent required. Advanced degree preferred.
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5-10 years of clinical research experience, including at least 3-5 years of experience in managing clinical trials as a leading role.
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1-2 years of experience of managing staff. Experience in managing CROs is preferred.
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Experience managing all aspects of the trials independently, including study design, protocol implementation, site monitoring, and recruitment site management.
KNOWLEDGE, SKILLS, AND ABILITIES:
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Familiar with the clinical research regulations.
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Ability to collaborate with the study team, cross functional team members and external
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Proficiency in MS Word, Excel and PowerPoint.
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Good organization and planning skills.
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Strong interpersonal skills and communication skills (both written and oral).
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Strong leadership skills, self-motivated, adaptable to a dynamic and fast paced environment.
