Clinical Biospecimen Operations Manager

Position Summary

The Clinical Biospecimen Operations Manager responsible for the execution of oncology clinical research studies, including coordination of all operational activities required for tracking, testing and reporting clinical trial samples. This position will perform required job duties with oversight from the Pharma Operations Team Leader and will work closely with internal and external central testing laboratories, vendors, Data Management, Product Management, Engineering and external collaborators in compliance with the study protocol(s), SOPs, and applicable regulatory requirements.

Primary Responsibilities

• Maintain oversight of all study sample operational activities including planning, coordinating and tracking clinical trial sample testing to ensure results are provided within agreed upon TAT
• Work with Data Management to develop and maintain dashboards and KPIs representing metrics and trends related clinical trial sample testing and the status of clinical studies and present to study teams and management teams, as needed.
• Meticulously track clinical trial samples from sample receipt to result reporting to investigator sites and/or external collaborators (and sample return, if applicable)
• Utilize operational and project management skills to anticipate, investigate and resolve issues to ensure deliverables and TAT are met; raise issues to Pharma Operations Team Leader
• Responsible for handling data files to support timely result reporting
• Review and provide input to clinical study protocol for sample collection requirements and alignment with the SOW, study plans and company policies
• Oversee clinical trial supplies related to biospecimen collection, processing, shipment, and storage as, well as maintenance of associated tracking information
• Organize and plan meetings and provide agenda and meeting minutes as needed
• Assist in developing study plans (e.g. Communication Plan) and departmental and study specific SOPs and work instructions with SME
• Assist in the preparation, handling, filing, and archiving of clinical documentation and reports according to SOPs and study requirements; set up and maintain study files in eTMF
• Monitor studies to identify protocol deviations or data discrepancies and issue data clarification forms, as needed
• Partner with other research and development groups at Natera to achieve deliverables
• This role works with PHI on a regular basis both in paper and electronic form and have access to various technologies to access PHI (paper and electronic) in order to perform the job.
• Must maintain a current status on Natera training requirement including General Policies and Procedure Compliance and security training.
• Employee must pass post offer criminal background check
• Employee must provide records of current training or complete training relating to HIPAA/PHI privacy, human subject’s protection, and GCP.
  
  

Qualifications

• BA/BS degree in life sciences, related field, or equivalent
• Minimum of 5 years of experience working on clinical studies in the academic, biopharma, diagnostics, or medical device fields
  
  

Knowledge, Skills, And Abilities

• Familiarity with biospecimen management, sample processing, and biobanking best practices
• 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 MS Word, Excel and PowerPoint
• Demonstrated ability to work independently
• Outgoing and confident demeanor
• Demonstrated analytical skills and ability to identify problems and propose solutions
• Detail oriented, with solid organization and time management skills
  
  

The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.

San Carlos, CA

$111,900—$139,900 USD

OUR OPPORTUNITY

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

What We Offer

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!

For more information, visit www.natera.com.

Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.

All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.

If you are based in California, we encourage you to read this important information for California residents.

Link: https://www.natera.com/notice-of-data-collection-california-residents/

Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.

For More Information

• BBB announcement on job scams
• FBI Cyber Crime resource page