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Clinical Program Manager
Posted on 4/15/2022
INACTIVE
Locations
Remote
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Google Cloud Platform
Leadership
Management
Requirements
  • Bachelor's degree or equivalent in the life sciences or related field required. Additional coursework in clinical trial planning and execution is strongly desired
  • Ideal candidate will have at least 7 years of relevant experience in managing clinical trials (minimum 2 years of managerial experience) in sponsor organizations with a strong track record of successful trial initiation and execution
  • Industry experience within in vitro diagnostics (IVD) highly preferred; pharmaceutical, biologics or medical device experience also acceptable
  • Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements
  • Working experience with an electronic data capture system, CTMS system, and eTMF system
  • Strong interpersonal communication (written and verbal), organizational and prioritization skills
  • Able to work effectively under a fast-paced and changing environment
  • Strong work ethic and demonstrated ability to deliver assignments on time
  • Proficient with office automation tools, such as Microsoft Office and the Google suite of apps
Responsibilities
  • Provides leadership and oversight to effectively manage the entire lifecycle of a clinical trial while ensuring all study deliverables are met within timeline and study budget
  • Accountable for all operational aspects of a clinical trial including quality, safety, and compliance
  • Develop and maintain enrollment and budget forecast
  • Proactively identifies potential issues/risks and implements appropriate mitigation plans to issue resolution
  • Contributes to the development, review, and implementation of departmental SOPs and processes including process improvement initiatives
  • Represents Clinical Operations at cross-functional meetings and is accountable in making study level operational decisions
  • Reviews and approves all study related materials (i.e. protocols, informed consent forms, recruitment plans, monitoring plans, protocol deviation plans)
  • Develops Clinical Operations study timelines
  • Provides regular study status updates to management on study progress
  • Develops RFPs (Request for Proposals), leads vendor selection process, and manages external vendors (i.e. CROs)
  • Responsible for daily management of vendors (i.e. CROs) and study monitoring
  • Responsible for the oversight of the Trial Master File (TMF)
  • Ensures the conduct of the clinical trial is in compliance with study plans, study protocol, SOPs, FDA regulations, ICH/GCP guidelines, and in accordance with all applicable regulations
  • Leads department, development, or cross-functional initiatives
  • Provides guidance, mentorship, and career development to direct reports
GRAIL

501-1,000 employees

Designs cancer screening tests
Company mission
GRAIL's mission is to detect cancer early, when it can be cured. They are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.
Benefits
  • Outstanding People - Join a team of passionate and dedicated professionals, committed to collaboration, education, and proactive problem-solving.
  • Strong Compensation - We offer competitive salaries and savings plans to provide for long-term financial planning.
  • Complete Health Coverage - Take advantage of comprehensive health coverage, with medical, dental and vision, to keep you and your family healthy.
  • Work-Life Balance - Make everyday life more manageable with flexible time off – we trust you to do great work and take time for yourself.
Company Values
  • Grit - We are determined and resilient because patients are counting on us.
  • Respect - We value diversity and challenge each other respectfully.
  • Accountability - We own our decisions and keep our commitments.
  • Integrity - We adhere to our principles of humility, transparency, and rigor.
  • Leadership - We make each other better by making leadership everyone’s responsibility