Clinical Trials Training & Change Manager

San Carlos, CA

POSITION SUMMARY:

The Clinical Trials Training & Change Manager is responsible for developing, managing, and delivering
training programs for a department of 70+ clinical operations staff. This individual will ensure that all team
members are proficient in clinical trial processes, systems, and compliance with regulatory standards. The
Training & Change Manager will collaborate with functional leads and subject matter experts (SMEs) to
create a scalable training framework, ensuring organizational readiness and operational excellence.

PRIMARY RESPONSIBILITIES:

Design and implement training programs for SOPs, GCP compliance, clinical trial systems (e.g.,
CTMS, eTMF), and study-specific protocols.
● Collaborate with leadership to identify training and communication needs of the organization.
● Develop instructor-led sessions, workshops. and e-learning modules tailored to various roles
(CRAs, CBOMS, data managers, etc.)..
● Ensure training programs meet FDA, EMA, ICH-GCP, and other global regulatory requirements.
● Maintain training documentation to support audit and inspection readiness, monitor and report on
training completion rates and identify compliance gaps.
● Conduct refresher courses to address regulatory updates or inspection findings.
● Lead change management efforts for the adoption of new or updated processes, SOPs, or
systems within the clinical operations department.
● Monitor the adoption of new processes or systems, gather feedback, and provide follow-up
support as needed.
● Establish and maintain strong relationships with business partners, subject matter experts, and
stakeholders.
● Act as a liaison between teams and stakeholders to address resistance and foster engagement,
evaluate the effectiveness of training programs through surveys, feedback, and metrics.
● Recommend and implement improvements to training tracking and reporting processes.
● Conduct training needs assessments to identify gaps and prioritize initiatives.
● Employee must complete training related to HIPAA/PHI privacy, General Policies, Procedure
Compliance, and security as soon as possible but not later than the first 30 days of hire.
● Performs other duties as assigned

QUALIFICATIONS:

● Bachelor’s degree in a relevant field (e.g., Life Sciences, Education, or Business). Advanced
degree preferred.
● Minimum of 5 years of experience in clinical operations or clinical trial training, preferably within a
CRO, sponsor, or biotech environment.
● Experience working in Clinical Systems (eTMF, CTMS, etc.).
● Experience with Salesforce Administration is preferred.
● Familiarity with Learning Management Systems (LMS) and e-learning tools.
● Strong understanding of GCP, ICH guidelines, and global regulatory requirements.
● Certification in GCP or related training preferred (e.g., ACRP, DIA certifications).

KNOWLEDGE, SKILLS, AND ABILITIES:

Familiarity with change management frameworks (e.g., ADKAR, Prosci) is a plus.
● Strong communication and stakeholder management skills to support transitions.
● Exceptional communication and presentation skills.
● Strong organizational skills and ability to manage multiple priorities independently.
● Proven ability to work collaboratively with cross-functional teams.
● Detail oriented, with solid organization, planning, and time management skills.
● Ability to manage multiple projects and priorities in a fast-paced environment.
● Strong customer focus.

PHYSICAL DEMANDS & WORK ENVIRONMENT:

  • This position requires the ability to use a computer keyboard, communicate over the telephone
    and read printed material.
  • Duties may require working outside normal working hours (evenings and weekends) at times.

 

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

$135,000 - $160,000 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 

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