Senior Manager, Clinical Trials

Requirements

• Bachelor's degree in life sciences, other relevant discipline, or equivalent required. Advanced degree preferred.
• 5-10 years of clinical research experience, including at least 3-5 years of experience in managing clinical trials as a leading role.
• 2+ years of experience of managing staff. Experience in managing CROs is preferred.
• Experience managing all aspects of the trials independently, including study design, protocol implementation, site monitoring, sample management, and recruitment site management.
• KNOWLEDGE, SKILLS, AND ABILITIES:
• Familiar with the clinical research regulations.
• Ability to collaborate with the study team, cross functional team members and external
• Proficiency in MS Word, Excel and PowerPoint.
• Good organization and planning skills.
• Strong interpersonal skills and communication skills (both written and oral).
• Strong leadership skills, self-motivated, adaptable to a dynamic and fast paced environment.
• Remote USA
• $141,300 - $176,600 USD
• OUR OPPORTUNITY

Benefits

Additional Information

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: Responsible for the implementation of clinical trial activities per study protocol. Works closely with investigative site personnel, CROs, and other study vendors Manage and coach clinical research staff. Manage study contracting, budget and payment process for all clinical trial vendors including investigational sites. Partner with department head to develop department procedures and develop infrastructure. Design study related documents, including but not limited to study protocol, informed consent forms, CRFs, and regulatory binders. Train CROs, vendors, investigators and study coordinators on study protocol and relevant Monitor and track clinical trial progress and provide status update to stakeholders. Partner with other research and development groups to achieve deliverables. 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 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. Must maintain a current status on Natera training requirements.

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