Manage and drive continuous process improvement initiatives, establishing best practices, and developing standard operating procedures (SOPs) for data operations workflows.
Oversees all daily, end to end, clinical trial/patient matching operations, from planning through reporting.
Serve as a liaison between trial sites, sponsors, PIs, and Natera and drive project delivery, productivity, and quality to ensure contractual KPIs and financial performances are met and customers are satisfied.
Accountable for the execution and meeting timelines of patient matching/clinical trial support activities, per contract, while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with policies (e.g., GCP) and SOPs.
Support business development by participating or providing guidance in bid defense presentations and lead the presentation for smaller, less complex regional studies.
Serve as a change advocate and adopt program changes.
Serve as the primary liaison for sponsors, investigators, and vendors and resolving concerns and queries.
Proactively identify potential project risks and develop mitigation strategies to ensure milestones are met on time and within budget.
Implement and maintain quality control processes to ensure data integrity and adherence to protocol and regulatory guidelines.
Develop comprehensive project plans, SOPs, timelines, budget estimates, resource allocation, risk management strategies, and other artifacts.
Set objectives of the core project team and/or sub-team(s) according to agreed upon contract, strategy and approach, effectively communicate and assess performance.
Oversee the creation and maintenance of accurate, complete, and up-to-date trial master files (TMF), study binders, and all other site and trial forms.
Exhibit deep understanding and familiarity of protocols, ensuring all procedures and requirements are followed by Natera.
Led engagement with providers to facilitate patient screening, recruitment, physician education, and eligibility discussions. Oversee and conduct timely and effective contractually defined outreach activities.
Led cross-functional engagement with software engineers, data management specialists, IT, and product management staff to deploy virtual and digital trial site activity, and the creation and maintenance of electronic data capture (EDC) systems or reporting and tracking tools.
Arrange and lead sponsor, client, and project related meetings, planning sessions, provide executive level reporting, track and report on KPIs (e.g., site participation and testing, site enrollment and patient volumes, and engagement scores).
Maintenance of all relevant clinical or technical licensures. Attend conferences relevant to role and clinical field.
Mentor and train junior project staff and contribute to the continuous improvement of Project Management processes and tools.
Support staff recruitment and onboarding.
Other duties and responsibilities to be performed as assigned.

Requirements

U. S. licensed Nurse, PA-C, NP, or DNP is preferred but not required with a Master’s degree in health sciences.
Strong understanding of medical terminology, disease processes (especially cancer), clinical data, and genetic testing.
5-6 years of experience providing project or program management leadership and skills to projects handling clinical data, clinical research, or clinical information.
4-5 years of experience hosting and leading meetings, project standup ceremonies, coordinating project timelines.
3-4 years of experience supporting cancer clinical trials.
Direct experience in managing study binders, trial master files, supporting study start-up and close, tracking study metrics, and identifying, screening, recruiting, and enrolling study subjects.
Demonstrated commitment to data integrity, quality control processes, and adherence to HIPAA and other data privacy regulations.
Proficient with Microsoft Office Suite or Google Suite, creating pivot tables, generating reports, data analysis, and using clinical data systems or databases common in clinical data abstraction, research, or clinical data management (e.g., fillable forms, ECDs, data registries).
Must hold an active PMP or relevant program or project management certification.
CCRC or CRA preferred.
Excellent written and verbal communication skills, with the ability to effectively collaborate with PIs, sponsors, patients, and non-clinical teams.
Proven ability to work independently, manage time effectively, prioritize and organize tasks, and meet strict productivity and quality deadlines.
High level of initiative and self-motivation.
Capable of working part of a team on high visibility projects and tasks with high rates of communication.
In-depth attention to detail and a fast learner.
Responding to shifting priorities and changes.

Benefits

Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
Free testing for Natera employees and their immediate families.
Fertility care benefits.
Pregnancy and baby bonding leave.
401k benefits.
Commuter benefits.
Employee referral program.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

project managementclinical data managementdata analysisrisk managementquality control processespatient matchingclinical trial supportprotocol adherencedata integrityclinical research

Soft Skills

communication skillsleadershiptime managementorganizational skillscollaborationinitiativeself-motivationattention to detailproblem-solvingadaptability

Certifications

PMPCCRCCRA