Clinical Trial Manager

POSITION SUMMARY:

The Clinical Trial Manager will be responsible for managing all aspects of clinical trials from start-up through close-out. The Clinical Trial Manager should have experience in managing all aspects of the trials independently, and is expected to provide functional expertise to ensure that study timelines, costs and quality metrics are met and the study is conducted in compliance with the study protocol, SOPs, and applicable regulatory requirements.

PRIMARY RESPONSIBILITIES:

• Manage the execution and conduct of all aspects of very complex clinical studies to ensure that timelines, cost, and quality metrics are met
• Responsible for selection of vendors/CROs and provide effective ongoing management to vendors/CROs working on the project to ensure compliance and execution of project deliverables within the approved budget, study timeline, and study protocol. Works closely with investigative site personnel, CROs, and other study vendors
• Manage study contracting, budget, forecasting, accruals and payment process for all clinical trial vendors including investigational sites
• Lead study-related activities such as protocol and informed consent preparation, investigator selection, study training material development and delivery, monitoring plans development and execution, CRFs, design and completion, TMF maintenance, protocol amendment and clinical report preparation, as required
• Collaborate with Clinical Data Management group to ensure correct CRFs content is collected, prepare comprehensive completion guidelines, and design effective data listings and study reports
• Train CROs, vendors, investigators and study coordinators on implementation of study protocol
• Hire, train and oversee Clinical trial staff, and serve as a resource for others within the company for clinical trials management expertise
• Monitor and track clinical trial progress and provide status update to stakeholders
• Support prospective sample testing for studies where Natera functions as a central testing facility
• Partner with other research and development groups to create a culture of mutual respect and focus on delivery of high-quality project results
• Hire, train and oversee Clinical trial staff, and mentor junior clinical operations staff.
• Develop Clinical Department SOPs and participate in audits as needed
• 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 provide records of current training or complete training relating to HIPAA/PHI privacy, Human Subjects Protection, and GCP training.
• Must maintain a current status on Natera training requirements including General Policies and Procedure Compliance and security training.

QUALIFICATIONS:

• Bachelor’s degree in life sciences, or other relevant discipline required, Advanced degree preferred.
• 8 years of clinical research experience, including at least 4 years of experience in managing clinical trials as a leading role.
• 4-7 years of experience in supporting clinical trials in a regulated environment.
• Experience in managing CROs is preferred.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Knowledge and understanding of Clinical Trial SOPs, FDA Regulations, and ICH-GCPs governing the conduct of clinical trials
• Demonstrated analytical skills and ability to identify problems and solutions independently
• Ability to collaborate with the study team, cross functional team members and external collaborators
• Proficiency in MS