Senior Clinical Trial Manager / Clinical Trial Manager (Clinical) - Remote - REF10770Y

Company: ProPharma Group
Location: Irvine
Posted on: June 25, 2022

Job Description:

Company DescriptionProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group's fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today's dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.Job DescriptionA Clinical Trial Manager is responsible for managing all aspects of clinical trials to support the development, validation, and commercialization of first -in - class assays interrogating circulating tumor DNA (ctDNA) and cell free fetal DNA (cffDNA) for the non -invasive detection and diagnosis of various cancers and fetal chromosomal anomalies. The Clinical Trial Manager should have experience in protocol implementation, site monitoring, and recruitment site management. The candidate will work closely with internal clinical trials, R&D and scientific communications teams to accomplish this end.Primary Responsibilities

• Responsible for the implementation of clinical trial activities per study protocol. Works closely with investigative site personnel, CROs, and other study vendors
• Manage study contracting, budget and payment process for all clinical trial vendors including investigational sites
• Design study related documents, including but not limited to study protocol, informed consent forms, CRFs, and regulatory binders
• Train CROs, vendors, investigators and study coordinators on study protocol and relevant requirement
• Monitor and track clinical trial progress and provide status update to stakeholders
• Partner with other research and development groups to achieve deliverables
• Professionally handle access to HIPAA information
• 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 complete training relating to HIPAA/PHI privacy, 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 training requirements.
• Employee must pass post offer criminal background check.Knowledge, Skills, And Abilities
  • Familiar with the FDA regulations relevant to clinical trials
  • Experience in managing CROs is desired
  • 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
  • Ability to collaborate with the study team, cross functional team members and external collaborators
  • Excellent interpersonal, communication, computer, and technical skills
  • Excellent oral and written communication skills
  • Must be detail oriented.
  • Flexible and very adaptable to change
  • Must have excellent organizational and time management skills.
  • Ability to prioritize and handle multiple tasks and projects in a fast-paced environment
  • Comfortable with logistics and coordination activities associated with providing support to C-suite executivesOncology Experience RequiredQualifications
    • Bachelor's degree in life sciences, or other relevant discipline required, an advanced degree preferred
    • Minimum of 8 years of related experience
    • 2- -5 years of experience in managing clinical trials in a regulated environmentAdditional InformationThis is a 6 month contract role, with possible extension.We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.We are an equal opportunity employer. M/F/D/V***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Keywords: ProPharma Group, Irvine , Senior Clinical Trial Manager / Clinical Trial Manager (Clinical) - Remote - REF10770Y, Healthcare , Irvine, California