Principal Biostatistician – Contractor
Sitero
Python
Clinical Trial Manager
Agilent Technologies
full-time
Posted on:
Location Type: Remote
Location: Remote • Florida • 🇺🇸 United States
Visit company websiteSalary
💰 $100,720 - $188,850 per year
Job Level
Junior
Tech Stack
Google Cloud Platform
About the role
- Manage, design and implement all clinical operational aspects of IVD clinical trials from inception through close-out
- Serve as main point of contact for internal and external study stakeholders; effectively communicating, collaborating, managing escalation of issues, where necessary, as well as participating and leading internal and external study meetings
- Identify, evaluate, and oversee qualification and contracting for study investigators, study sites, CRO and/or vendor management for the study, where applicable
- Develop or assist in the development of study-related plans and documents including protocols, informed consent forms, monitoring plans, case report forms, training plans and engagement materials
- Ensure trial master file (TMF/eTMF) is established, current, and maintained per ICH E6(R2). May coordinate study IRB/EC approvals
- Support and oversee study-related work of Clinical Research Associates (CRAs) to ensure proper site training and management, provide ongoing oversight of clinical site compliance with study plans, study protocol, internal SOPs, FDA CFR, ICH/GCP guidelines, and in compliance with all applicable regulations.
- Demonstrate compliance with and enforcement of these regulations and requirements
- Manage study deliverables and track study metrics including identifying potential risks to study timelines and/or conduct
- Review, suggest edits and approve monitoring trip reports for studies. Escalate issue and/or findings to senior management and/or leadership according to risk/severity.
- Participate in data management activities, such as CRF development, training, and facilitating query resolution
- Lead or contribute to organizational and departmental process development, improvement, and implementation
- Provide guidance and mentorship to junior team members.
Requirements
- Bachelor's degree or higher, or equivalent credentials
- Knowledge of GCP, ICH guidelines, and other clinical regulatory requirements
- Strong interpersonal skills (verbal and written), organizational, and prioritization skills, able to communicate at multiple levels of an organization and with sponsors/clients.
- Ability to work independently and effectively in a fast-paced environment
- Strong work ethic and ability to deliver tasks on time
- Proficient with office automation tools, especially Microsoft PowerPoint, Excel and Word.
- People management skills
- 1+ year of direct clinical study management experience or 5+ years of direct clinical operations experience with sponsor, CRO and/or companion diagnostics, device manufacturer, IVD, or similar industry(ies) demonstrating management or study lead experience with a track record of successful trial initiation and execution, or equivalent experience.
Benefits
- Eligibility for bonus
- Eligibility for stock
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial managementprotocol developmentmonitoring plan developmentcase report form developmentstudy deliverables managementrisk identificationdata managementstudy site complianceinvestigator qualificationvendor management
Soft skills
interpersonal skillsorganizational skillsprioritization skillscommunication skillsmentorshipindependencework ethiccollaborationproblem-solvingleadership
Certifications
Bachelor's degreeGCP certificationICH certification
