Senior Clinical Trial Manager

Summary

Join Natera as a Senior Clinical Trial Manager (CTM) and lead complex clinical studies from initiation to closure. Manage all aspects of trials, including vendor selection and management, budget control, and stakeholder communication. Responsibilities encompass protocol preparation, investigator selection, data management, and reporting. You will mentor junior staff and contribute to process improvements. This role requires a Bachelor's degree, 7+ years of relevant experience, and strong project management skills. Oncology experience is highly desired. Natera offers competitive benefits, including comprehensive medical, dental, vision, life, and disability plans, as well as free testing for employees and their families.

Requirements

• Bachelor’s Degree or equivalent required, PMP certification preferred
• 7 + years, of diagnostics, pharmaceutical or biotech-related/clinical research experience required
• Fully proficient in the management and execution of projects/trials/Labs/ including management of vendors and CROs
• Significant experience leading every phase of the project lifecycle (e.g., start-up, conduct and close-out activities)
• Must be capable of independently interfacing with external sponsors and KOLs as a Natera subject matter expert
• Interacts with senior internal and external personnel on significant matters
• Effectively presents information to external clients (e.g., Sponsors or KOLs)
• Performs assigned tasks and establishes timelines and priorities independently
• Is adept at presenting project requirements and status updates to stakeholders inside and external to Natera
• Exercises independent judgment in evaluating the criteria to achieve expected results
• Solves a variety of complex problems in imaginative ways
• Provides guidance and expertise to more junior team members
• Critically observes processes and has the drive to initiate process improvements when warranted
• Participates in developing courses of action that are high impact to Natera
• Considers the impact of actions and decisions when representing Natera externally
• Expertise and current training in Good Clinical Practice (GCP)
• Strong project management skills

Responsibilities

• Manage the execution and conduct of all aspects of very complex clinical studies to ensure that timelines, cost, and quality metrics are met
• Drive 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

Preferred Qualifications

Oncology clinical trial experience is highly desired

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!