Manager, Clinical Project Management

POSITION SUMMARY: 

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. 

PRIMARY RESPONSIBILITIES:

• Project Leadership and Oversight: 

  • 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.

  • Change Advocacy: Serve as a change advocate and adopt program changes.

  • Stakeholder Management: Serve as the primary liaison for sponsors,  investigators, and vendors and resolving concerns and queries. 

  • Risk Management: Proactively identify potential project risks and develop mitigation strategies to ensure milestones are met on time and within budget.

  • Data & Quality Assurance: Implement and maintain quality control processes to ensure data integrity and adherence to protocol and regulatory guidelines. 

• Study Planning and Execution: 

  • Develop comprehensive project plans, SOPs, timelines, budget estimates, resource allocation, risk management strategies, and other artifacts. 

  • Team Leadership and Performance Management: 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.

• Trial Management and Compliance

  • 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. 

  • Protocol Implementation: Exhibit deep understanding and familiarity of protocols, ensuring all procedures and requirements are followed by Natera.

• Outreach and Enrollment:  Led engagement with providers to facilitate patient screening, recruitment, physician education, and eligibility discussions. Oversee and conduct timely and effective  contractually defined outreach activities.

• Technical Adaptability: 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.

• Communication and Reporting: 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.)

• Conferences and Certifications: Maintenance of all relevant clinical or technical licensures. Attend conferences relevant to role and clinical field. 

• Team Development: Mentor and train junior project staff and contribute to the continuous improvement of Project Management processes and tools.

• New Hire Onboarding/Training: Support staff recruitment and onboarding.

• Other duties and responsibilities to be performed as assigned 

QUALIFICATIONS: 

• Clinical Background: 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.

• Project Management Experience: 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 experience hosting and leading meetings, project standup ceremonies, coordinating project timelines. 

• Clinical Trial Experience: 3-4 years of experience supporting cancer clinical trials. 

• Data Management Expertise: 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. 

• Quality and Compliance: Demonstrated commitment to data integrity, quality control processes, and adherence to HIPAA and other data privacy regulations. 

• Technical Proficiency: 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). 

• Certifications/Industry Expertise: Must hold an active PMP or relevant program or project management certification is required. CCRC or CRA preferred. Deep knowledge of and experience working in remote and decentralized clinical trials. 

• Communication: Excellent written and verbal communication skills, with the ability to effectively collaborate with PIs, sponsors, patients, and non-clinical teams.

• Autonomy: Proven ability to work independently, manage time effectively, prioritize and organize tasks, and meet strict productivity and quality deadlines.

• General Expertise:

  • Possess a 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.