Clinical Operations Analyst
Imagen Technologies
Associate Director, Clinical Operations
Parabilis Medicines
full-time
Posted on:
Location Type: Remote
Location: Remote • Massachusetts • 🇺🇸 United States
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Accountable for delivery of assigned clinical program/trial budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support trial and/or program objectives
- Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan
- Lead and execute all trial phases based on stage of development in compliance with ICH/GCP, local regulations and Parabilis procedures
- Manage and provide oversight to the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operations
- Evaluate, qualify, onboard and train vendors and investigative sites
- Review and provide clinical operations input into regulatory documents such as clinical trial protocols, informed consent forms (ICFs), investigator brochures, and study reports
- Perform and document study level Sponsor Oversight of outsourced clinical activities ensuring a trial storyboard is inspection ready
- Communicate study-status, cost and issues to ensure timely decision-making by senior management
- Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct
- Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance
- Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives
- Provide managerial oversight and mentorship to assigned clinical operations staff by providing clinical operations and functional area expertise and support identification and prioritization of study and program level work
- Conduct site and CRA oversight visits
- Drive trial and site level performance and engagement through regular communication, clear expectation setting, and development of action plans for issue remediation
- Develop and maintain strong relationships, including external partners such as investigators, site staff, collaborators and Key Opinion Leaders
- Program/trial budget management, reporting and forecasting activities
- Maintain current knowledge of external environment to ensure innovations (such as AI / Machine Learning) are considered and/or incorporated into clinical trial delivery strategy
Requirements
- B.S./B.A. in life science or related field
- 12+ years of clinical operations experience
- Experience in biotechnology, pharmaceutical and/or CRO industry
- Phase 1-3 global trial management experience, including first in human studies, preferably in Oncology
- Direct experience overseeing global CROs in both fully and partially outsourced models
- 3+ years of on-site monitoring experience preferred
- Direct line management experience
- Ability to guide study teams and to coordinate across multiple disciplines to achieve study goals and timelines
- Ability to motivate and inspire teams
- Awareness of drug supply chain
- Ability to work on complex or multiple projects and exercise critical thinking with minimal supervision
- Solid attention to detail and excellent organizational skills
- Strong interpersonal and communication skills (both written and oral)
- Supportive team member with a willingness and ability to fill functional gaps in a small but growing organization
- Ability to establish priorities, excellent sense of urgency and a strong desire to collaborate (self-aware, effective relationship management and interpersonal skills)
- Creative problem-solving skills
- Self-motivated and adaptable in a dynamic, nimble, start-up environment
- Strong computer skills and experience using Microsoft Office applications, CTMS, eTMF, IRT and EDC platforms
- Ability to work on-site or remotely and attend in-person meetings
- Willingness to travel (up to 30%)
Benefits
- Competitive salary
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical operationsglobal trial managementbudget managementregulatory document reviewvendor managementstudy oversightmonitoring experiencecritical thinkingproject managementOncology
Soft skills
leadershipcommunication skillsteam motivationorganizational skillsproblem-solvingrelationship managementattention to detailadaptabilitycollaborationself-motivation
Certifications
B.S./B.A. in life science or related field
