Clinical Trial Manager | JobSetuu
Natera
Posted 1 day ago • Via jobicy.com
Description
Job Overview
- Source: Jobicy
Job Description
- Manage the execution and conduct of all aspects of very complex clinical studies to ensure that timelines, cost, and quality metrics are met
- Responsible for 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 and clinical report preparation, as required
- 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
- Train CROs, vendors, investigators and study coordinators on implementation of study protocol
- Hire, train and oversee Clinical trial staff, and 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
- Support prospective sample testing for studies where Natera functions as a central testing facility
- Partner with other research and development groups to create a culture of mutual respect and focus on delivery of high-quality project results
- Hire, train and oversee Clinical trial staff, and mentor junior clinical operations staff.
- Develop Clinical Department SOPs and participate in audits as needed
- This role works with PHI on a regular basis both in paper and electronic form and have an access to various technologies to access PHI (paper and electronic) in order to perform the job.
- Employee must provide records of current training or complete training relating to HIPAA/PHI privacy, Human Subjects Protection, and GCP training.
- Must maintain a current status on Natera training requirements including General Policies and Procedure Compliance and security training.
- Bachelor’s degree in life sciences, or other relevant discipline required, Advanced degree preferred.
- 8 years of clinical research experience, including at least 4 years of experience in managing clinical trials as a leading role.
- 4-7 years of experience in supporting clinical trials in a regulated environment .
- Experience in managing CROs is preferred.
- Knowledge and understanding of Clinical Trial SOPs, FDA Regulations, and ICH-GCPs governing the conduct of clinical trials
- Demonstrated analytical skills and ability to identify problems and solutions independently
- Ability to collaborate with the study team, cross functional team members and external collaborators
- Proficiency in MS Word, Excel and PowerPoint
- Good organization and planning skills
- Strong interpersonal skills and communication skills (both written and oral)
- Strong leadership skills, self-motivated, adaptable to a dynamic and fast paced environment
- Must have excellent organizational and time management skills.
- Ability to prioritize and handle multiple tasks and projects in a fast-paced environment
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
Expert Career Tips for Clinical Trial Manager Roles
To succeed in a competitive market as a Clinical Trial Manager, you need more than just technical skills. Here are some expert strategies to elevate your profile:
- Build a Strong Portfolio: For technical roles, a clean GitHub or a personal project site is essential. For non-technical roles, a case study portfolio demonstrating problem-solving and impact is equally valuable. Show, don't just tell, what you have achieved in your previous positions.
- Master the Narrative: When interviewing, use the STAR method (Situation, Task, Action, Result) to structure your answers. Quantify your results wherever possible—mentioning "increased efficiency by 20%" is much more impactful than saying "improved efficiency."
- Continuous Learning: The industry moves fast. Whether it's staying updated with the latest AI tools or mastering a new management methodology, continuous professional development is key. Consider obtaining industry-recognized certifications that align with Clinical Trial Manager requirements.
- Networking: Connect with other professionals in similar roles. Join online communities, attend webinars, and engage in meaningful discussions on professional social networks. Often, the best opportunities come through referrals and community engagement.
- Soft Skills Matter: Communication, empathy, and leadership are often the deciding factors between two equally qualified technical candidates. Cultivate these skills as they are universally valued across all industries and seniority levels.
Additionally, research the specific company's culture and values. Tailoring your application to show how you align with their mission can significantly increase your chances of moving forward in the process.
Salary & Compensation
Salary not disclosed; typically competitive for the role.
Work Arrangement
Type: On-Site
Standard business hours at the office.
Comprehensive Application Strategy & Hiring Process
Applying for a new role is a marathon, not a sprint. Follow this strategic approach to maximize your success rate:
1. Initial Research & Tailoring
Don't send the same resume to every employer. Spend at least 30 minutes researching the company. Look for recent news, their product roadmap, and their team structure. Modify your summary and core competencies to reflect the specific keywords found in the job description.
2. The Perfect Cover Letter
If the application allows for a cover letter, use it to tell a story that your resume cannot. Explain why you are passionate about this specific company and how your unique background makes you the perfect fit for the challenges they are currently facing.
3. Navigating the Multi-Stage Interview
Most modern hiring processes involve 3-5 stages. This typically includes a recruiter screen, a technical or skill-based assessment, a peer interview, and a final leadership round. Prepare for each stage differently: focus on enthusiasm and fit for the recruiter, technical depth for the assessment, and strategic vision for the leadership round.
4. Post-Interview Follow-Up
Always send a personalized thank-you note within 24 hours of each interview. Reference a specific topic discussed during the call to demonstrate your active listening and genuine interest in the role.
By following these steps, you demonstrate a high level of professionalism and attention to detail that sets you apart from the average applicant.
Typical Interview Process
- Resume screening
- HR call
- Skill interview
- Final manager interview
- Offer
Tip: Research the company's products and culture.
Global Market Intelligence & Relocation Insights
At JobSetuu, we specialize in helping talent navigate the global job market. Here is what you need to know about the current landscape in Global and beyond:
The demand for skilled professionals is increasingly borderless. For roles based in Global, understanding the local cost of living, visa requirements (if applicable), and cultural nuances is vital. If this is a remote role, consider the time zone alignment and the asynchronous communication culture of the hiring organization.
Relocation Support: Many forward-thinking companies offer relocation packages that include moving stipends, temporary housing, and legal assistance with work permits. When evaluating an offer, look beyond the base salary—consider the total compensation package, including equity, bonuses, and healthcare benefits.
Work-Life Balance Trends: Hybrid and remote work have become standard in many regions. Research the local labor laws and common practices regarding work hours and vacation time to ensure the role aligns with your lifestyle goals.
Leveraging JobSetuu's tools can help you compare salaries across different cities and understand the "purchasing power" of your potential offer, ensuring you make an informed decision for your long-term career path.
Skills & Competency Roadmap for Professional Development
To remain competitive in Professional Development, we recommend focusing on the following core competencies over the next 12-18 months:
- Technical Mastery: Deepen your expertise in the core tools and languages relevant to your field. For developers, this might be cloud architecture; for marketers, it might be data-driven attribution modeling.
- AI Augmentation: Learn how to leverage generative AI and automation tools to increase your productivity. Understanding how to integrate these technologies into your workflow is becoming a non-negotiable skill.
- Leadership & Strategy: Even in individual contributor roles, the ability to think strategically and lead projects from inception to completion is highly valued. Focus on stakeholder management and high-level project planning.
- Data Literacy: The ability to interpret data and use it to drive decisions is essential across all business functions. Familiarize yourself with data visualization and basic analytical concepts.
By investing in these areas, you not only prepare yourself for the role you are applying for today but also build a resilient foundation for the opportunities of tomorrow.
Apply via JobSetuu
Discover your next career milestone on JobSetuu. This Clinical Trial Manager position is part of our commitment to bringing you the most relevant and high-impact job openings globally. At JobSetuu, we simplify your job search by aggregating premier listings and providing the tools you need to stand out. Don't miss the chance to elevate your professional journey—explore more opportunities and career insights on our platform today.
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