Senior Clinical Trial Manager

POSITION SUMMARY:

The Senior Clinical Trial Manager will be responsible for managing all aspects of clinical trials in the field of Oncology. The Clinical Trial Manager should have experience in managing all aspects of the trials independently, including study design, protocol implementation, site monitoring, and recruitment site management. Natera is dedicated to robust clinical trial design and execution, as demonstrating test ability and performance is essential to Natera's reputation and integrity. The candidate will work closely with Natera's clinical trials, R&D and scientific communications teams to accomplish this end.

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 study contracting, budget and payment process for all clinical trial vendors including investigational sites.

• 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 requirement.

• Monitor and track clinical trial progress and provide status update to stakeholders.

• Partner with other research and development groups to achieve deliverables.

• Mentor junior clinical operations staff and supervise clinical study team.

• 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.

QUALIFICATIONS:

• Bachelor’s degree in life sciences, or other relevant discipline required, Advanced degree preferred.

• 5-8 years of clinical research experience, including at least 2-5 years of experience in managing clinical trials as a leading role.

• Familiar with the FDA regulations relevant to clinical trials.

• Experience in managing studies, CROs and sponsors is preferred.

• Able to collaborate with the study team, cross functional team members and external collaborators

KNOWLEDGE, SKILLS, AND ABILITIES:

• 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

The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.

Remote USA

$131,900—$164,900 USD

OUR OPPORTUNITY

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized