Clinical Trial Manager

Summary

Join Natera as a Clinical Trial Manager and oversee all aspects of clinical trials, from initiation to completion. Manage study execution, vendor relationships, and budgets. Lead study-related activities, including protocol preparation, investigator selection, and data analysis. Collaborate with internal and external stakeholders, providing regular project updates. Train and mentor junior staff, leveraging expertise in clinical trials management. Maintain compliance with regulations and SOPs. This role requires strong analytical, organizational, and communication skills.

Requirements

• BA/BS degree in life sciences, related field, or equivalent
• 5 years of clinical research experience, including at least 4 years of experience in managing clinical trials as a leading role
• Familiarity with biospecimen management, sample processing, and biobanking best practices
• Experience with clinical EDC systems
• Familiarity with the organization and structure of the Trial Master File (TMF)
• Competency in SOPs, ICH-GCP, FDA Regulations
• Proficiency in Google Workspace (gSuite), MS Word, Excel and PowerPoint
• Demonstrated ability to work independently
• Outgoing and confident demeanor
• Demonstrated analytical skills and ability to identify problems and propose solutions
• Detail oriented, with solid organization and time management skills

Responsibilities

• Manage the execution and conduct of all aspects of clinical studies to ensure that timelines and quality metrics are met
• Assists with the 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, lab manuals and clinical report preparation, as required
• Lead and prepare content for internal study meetings and external study webinars
• Responsible for the day to day management of the study/project and tracking to OKRs for key deliverables
• 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
• Oversee the clinical operations aspects of timely data cleaning, data analysis and the availability of results for data cuts and publications; participate in data reviews
• Is adept at providing routine project status updates (internal to Natera) -May present information to external clients (e.g., Sponsors or KOLs)
• Train CROs, vendors, investigators and study coordinators on implementation of study protocol
• Mentor junior staff. 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
• Partner with other groups (e.g., Research, Medical Affairs) to create a culture of mutual respect and focus on delivery of high-quality project results
• External interactions (with clinical sites, vendors or collaborators) require ability to communicate complex concepts
• Demonstrates potential to lead others through influence
• Participates in developing courses of action that are high impact to Natera taking into consideration needs of stakeholders
• Checks in with manager and executes solutions and work independently
• This role works with PHI on a regular basis both in paper and electronic form and utilizes various technologies to access PHI (paper and electronic) in order to perform the job
• Employee must complete training or provide training records relating to HIPAA/PHI privacy, Humans Subjects Protection, GCP, 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
• Performs other duties as assigned

Benefits

• Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits
• Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more
• We also offer a generous employee referral program!