Remote Clinical Trials Manager: Complex Study Leadership

Natera

United States

Remote

USD 116,000 - 145,000

Full time

14 days+

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Job summary

Natera is seeking a Manager, Clinical Trials to oversee end-to-end execution of complex studies, manage CROs and vendors, and ensure timelines, costs, and quality meet protocol standards and regulatory requirements. The role emphasizes HIPAA/PHI awareness and cross-functional leadership.

Ideal candidates will have a life sciences degree, 8+ years in clinical research, and 4+ years in leading clinical trials, with strong organizational and communication skills for a fast-paced environment.

Qualifications

Knowledge 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 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
Must have excellent organizational and time management skills.
Ability to prioritize and handle multiple tasks and projects in a fast-paced environment

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
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, manage 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 sample management and 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
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 ProcedureCompliance and security training.
Employee must pass post offer criminal background check