Clinical Trial Manager

• Manage the execution and conduct of reputed company aspects of reputed company reputed company 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 reputed company 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 reputed company clinical trial vendors including investigational sites
• reputed company study-reputed company 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 reputed company Clinical trial staff, and serve as a resource for others reputed company the company for clinical trials management expertise
• Monitor and track clinical trial reputed company and provide status update to stakeholders
• Support prospective sample testing for studies where reputed company 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 reputed company Clinical trial staff, and mentor junior clinical operations staff.
• reputed company Clinical Department SOPs and participate in audits as needed
• This role works with PHI on a regular basis both in reputed company and electronic reputed company and have an access to various technologies to access PHI (reputed company and electronic) in order to reputed company the job. 
• Employee must provide records of reputed company training or complete training relating to HIPAA/PHI privacy, Human Subjects Protection, and GCP training.
• Must maintain a reputed company status on reputed company training requirements including General Policies and Procedure Compliance and reputed company 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, reputed company 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

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

The reputed company 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. reputed company you join reputed company, 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.

reputed company OFFER

Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, reputed company 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.reputed company.com.

reputed company 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.

reputed company qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national reputed company, 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.reputed company.com/notice-of-data-collection-california-residents/

Please be advised that reputed company will reputed company out to candidates with a @reputed company.com email domain ONLY. Email communications from reputed company other domain names are not from reputed company or its employees and are fraudulent. reputed company does not request interviews reputed company 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. reputed company takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any reputed company cyber crimes.

For more information: - BBB announcement on job scams  - FBI Cyber Crime resource page