New

Mgr, Clinical Trials

US Remote

POSITION SUMMARY:

The Manager, Clinical Trials Operations oversees a group of Clinical Research Associates and Senior
Clinical Research Associates (1-4 typically) working on multiple related projects/studies.  This role
should have experience managing all aspects of the trial independently while providing direct
management and functional expertise to individual contributors to ensure study timelines, costs and
quality metrics are met and the study is conducted in compliance with the study protocol, SOPs, and
applicable regulatory requirements.

PRIMARY RESPONSIBILITIES:

  • Develop and manage an effective team of professionals dedicated to delivery of Natera
  • Sponsored Studies (NSS).
  • Is directly responsible for/leads a team that performs:
  • Maintain oversight of all study operational activities including leading study requirements
  • efforts to drive readiness timelines, kick-off and planning activities, study conduct
  • management within the boundaries of the approved plan of record, and closure
  • activities. Ensure timelines and quality metrics are met.  
  • Regularly monitors the overall health of the study from study start-up through closure,
  • including regular evaluation of key metrics (enrollment, site activation), monitoring
  • oversight metrics, data metrics, project management of key milestones and activities, and
  • escalation of project risks and mitigation plans when appropriate.
  • Assists with the 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. Works closely with investigative
  • site personnel, CROs, and other study vendors.
  • 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, lab manuals
  • and clinical report preparation, as required.
  • Lead and prepare content for internal study meetings and external study webinars.
  • 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.
  • Oversee the clinical operations aspects of timely data cleaning, data analysis and the availability
  • of results for data cuts and publications; participate in data reviews.
  • Is adept at providing routine project status updates (internal to Natera) -May present information
  • to external clients (e.g., Sponsors or KOLs).
  • Train CROs, vendors, investigators and study coordinators on implementation of study protocol.
  • Partner with internal stakeholders from Data Management, Biostatistics, Medical, BCP to
  • ensure on-schedule delivery of sample and study management requirements.
  • Facilitate the personal development of staff, including fostering career growth, and
  • providing relevant company-specific, ethical, and regulatory trainings. Serves as a mentor
  • and guide to junior employees.
  • Responsible for staffing of assigned projects and for development of direct reports.
  • Employee must complete training or provide training records relating to HIPAA/PHI privacy,
  • Humans Subjects Protection, GCP, General Policies and Procedure Compliance training and
  • security training as soon as possible but not later than the first 30 days of hire.
  • Must maintain a current status on Natera training requirements.
  • Performs other duties as assigned.

QUALIFICATIONS:

  • Bachelor’s Degree or equivalent required in a scientific relevant field, PMP certification
  • preferred.
  • Advanced proficiency in job related technical skills. 
  • 5 years of clinical research experience, including at least 4 years of experience in managing clinical trials as a leading role. Oncology experience a plus.
  • Proven record of working effectively with and across business areas (clinical science, medical affairs, research & development, finance, regulatory, legal, sales, contracting, business development, etc.).
  • Proficiency in Google Workspace (gSuite), MS Word, Excel and PowerPoint.

KNOWLEDGE, SKILLS, AND ABILITIES:

  • Performs assigned tasks and establishes timelines and priorities independently.
  • Familiarity with biospecimen management, sample processing, and biobanking best practices.
  • Provides guidance and expertise to more junior team members.
  • 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 Google Workspace (gSuite), MS Word, Excel and PowerPoint.
  • Demonstrated analytical skills and ability to identify problems and propose solutions.
  • Detail oriented, with solid organization and project management skills.

Travel required for this position:
No _ or Yes __X_: If yes state anticipated percent for travel: > 10%

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.

Remote USA

$115,800 - $144,700 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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