Job description
POSITION SUMMARY:
The Clinical Trial Manager will be responsible for managing all aspects of clinical trials from start-up through close-out. The Clinical Trial Manager should have experience in managing all aspects of the trials independently, and is expected to provide functional expertise to ensure that 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:
Manage the execution and conduct of all aspects of clinical studies to ensure that timelines and quality metrics are met
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
Responsible for the day to day management of the study/project and tracking to OKRs for key deliverables
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
Mentor junior staff. Serve as a resource for others within the company for clinical trials management expertise
Monitor and track clinical trial progress and provide status update to stakeholders
Partner with other groups (e.g., Research, Medical Affairs) to create a culture of mutual respect and focus on delivery of high-quality project results
External interactions (with clinical sites, vendors or collaborators) require ability to communicate complex concepts
Demonstrates potential to lead others through influence
Participates in developing courses of action that are high impact to Natera taking into consideration needs of stakeholders
Checks in with manager and executes solutions and work independently
This role works with PHI on a regular basis both in paper and electronic form and utilizes various technologies to access PHI (paper and electronic) in order to perform the job.
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:
BA/BS degree in life sciences, related field, or equivalent
5 years of clinical research experience, including at least 4 years of experience in managing clinical trials as a leading role
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 Google Workspace (gSuite), 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
PHYSICAL DEMANDS & WORK ENVIRONMENT
This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer is required. May stand for extended periods when facilitating meetings or walking in the facilities.
The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.
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
$120,000—$155,000 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
