Clinical Trial Manager
Agilent Technologies
Google Cloud Platform
Senior Clinical Trial Manager
Exact Sciences
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $89,000 - $151,000 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Coordinate and oversee the operational aspects of a study including planning, start-up, enrollment and close out activities ensuring that deliverables are completed on time, within budget, and in compliance with department procedures, applicable regulations and quality standards
- Prepare, review and implement study related plans and documents including project timelines, study protocols, informed consent forms (ICFs), recruitment plans, monitoring plans, study budgets, site contracts & budgets, vendor management plans and other essential clinical study documents
- Develop plans for systems and materials required to support the efficient execution of clinical studies and is responsible for effective management during the conduct of the study
- Develop, implement and maintain tools to manage, monitor and report on study health & operations, project timelines, and study finances to department management and other stakeholders
- Participate in study database development by reviewing and contributing to case report form (CRF) design, CRF completion guideline development, edit check & manual data review requirements, and participation in user acceptance testing (UAT)
- Oversee sample management activities including planning, sample handling, kit supply management, sample shipping, processing, and resulting
- Develop site recruitment plans and is responsible for the identification, selection, start-up and performance monitoring of clinical research sites
- Develop study budgets and is responsible for accurately forecasting and managing study expenses
- Oversee site contracting and study budget management including facilitation of site contract and budget negotiations, invoice review and approval, accrual management and maintenance of budget tracking tools
- Oversee study and site management activities such as, training, data entry & query resolution, TMF maintenance, and ensure compliance with study plans such as the study protocol, monitoring plans, and recruitment plans
- Conduct monitoring activities as needed
- Ensure the smooth and efficient closure of studies through development of plans for completion of data verification & review, planning & facilitation of database lock activities, determination of site & IRB/EC readiness for closure, statistical analysis and clinical study report development
- Participate in the identification, qualification, selection and management of vendors providing support to clinical studies
- Provide oversight and support for assigned clinical operations study team members
- Leads cross-functional team meetings, ensuring study goals and priorities are clear
- Professionally interacts with investigators and site staff, vendors, key opinion leaders and consultants
- Ability to identify, mitigate and manage study risks
- Responsible for maintaining ongoing study audit readiness and participates in internal or regulatory authority audits
- Provide guidance and support to less experienced team members
- Fosters a collaborative and knowledge-sharing environment, promoting continuous learning within the team
- Ability to provide oversight to multiple studies
- Participate or may facilitate department or project initiatives under the direction of department management or lead clinical trial manager
- Uphold company mission and values through accountability, innovation, integrity, quality and teamwork
- Support and comply with the company’s Quality Management System policies and procedures
- Maintain regular and reliable attendance
- Ability to work a designated schedule
Requirements
- Bachelor’s degree in the life sciences or field as outlined in the essential duties
- 5+ years of experience in clinical research
- 1+ year of experience leading project teams through the start-up, study conduct, data management, analysis, close out and report writing of clinical studies
- Clinical monitoring experience including data review, query resolution, protocol deviation identification/tracking/trending, site initiation, site maintenance, and site closeout visits
- Experience writing, reviewing and editing protocols
- Knowledge of applicable quality standards (e.g. Good Clinical Practices (ICH/GCP), ISO 20916) and applicable local and national regulations governing clinical research
- Authorization to work in the US without sponsorship
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation
- Experience providing oversight to external vendors (e.g. CRO, central labs, call centers, DCT providers)
Benefits
- Paid time off (including days for vacation, holidays, volunteering, and personal time)
- Paid leave for parents and caregivers
- Retirement savings plan
- Wellness support
- Health benefits including medical, prescription drug, dental, and vision coverage
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical researchproject managementdata managementprotocol writingbudget managementsample managementvendor managementclinical monitoringstatistical analysisdatabase development
Soft skills
leadershipcommunicationcollaborationproblem-solvingrisk managementteam supporttrainingoversightaccountabilitycontinuous learning
Certifications
Bachelor’s degree in life sciencesGood Clinical Practices (ICH/GCP)ISO 20916
