Clinical Trials Manager

Summary

Join Natera as a Manager, Clinical Trials Operations and lead a team of Clinical Research Associates. You will oversee all aspects of clinical trials, from study start-up to closure, ensuring compliance and timely completion. Responsibilities include managing budgets, vendors, and study-related activities. You will also mentor junior employees and contribute to their professional development. A Bachelor's degree in a scientific field and 5 years of clinical research experience, including 4 years managing clinical trials, are required. Oncology experience and PMP certification are preferred. 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 in a scientific relevant field
• Advanced proficiency in job related technical skills
• 5 years of clinical research experience, including at least 4 years of experience in managing clinical trials as a leading role
• Proven record of working effectively with and across business areas (clinical science, medical affairs, research & development, finance, regulatory, legal, sales, contracting, business development, etc.)
• Proficiency in Google Workspace (gSuite), MS Word, Excel and PowerPoint
• Performs assigned tasks and establishes timelines and priorities independently
• Familiarity with biospecimen management, sample processing, and biobanking best practices
• Provides guidance and expertise to more junior team members
• 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 analytical skills and ability to identify problems and propose solutions
• Detail oriented, with solid organization and project management skills

Responsibilities

• Develop and manage an effective team of professionals dedicated to delivery of Natera Sponsored Studies (NSS)
• Maintain oversight of all study operational activities including leading study requirements efforts to drive readiness timelines, kick-off and planning activities, study conduct management within the boundaries of the approved plan of record, and closure activities. Ensure timelines and quality metrics are met
• Regularly monitors the overall health of the study from study start-up through closure, including regular evaluation of key metrics (enrollment, site activation), monitoring oversight metrics, data metrics, project management of key milestones and activities, and escalation of project risks and mitigation plans when appropriate
• 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
• 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
• Partner with internal stakeholders from Data Management, Biostatistics, Medical, BCP to ensure on-schedule delivery of sample and study management requirements
• Facilitate the personal development of staff, including fostering career growth, and providing relevant company-specific, ethical, and regulatory trainings. Serves as a mentor and guide to junior employees
• Responsible for staffing of assigned projects and for development of direct reports
• 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

• PMP certification
• Oncology experience

Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• Natera employees and their immediate families receive free testing in addition to fertility care benefits
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits
• Generous employee referral program