Senior Clinical Trial Leader (Sr. CTL)
SUMMARY: The Senior Clinical Trial Leader (Sr.CTL) acts as a senior clinical trial lead on one or more clinical studies. He/She develops, manages and coordinates all clinical trial activities for their studies including managingClinical Research Organizations (CROs), vendors and internal team members.The Sr CTL develops and applies best practices in the development, initiation, planning, execution, control and closing of projects. He/She is a proficient communicator and effective influencer who builds and maintains strong relationships internally and externally. All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with the company’s Standard Operating Procedures.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Lead more than one or highly complex, adaptive or pivotal studies
- Plan and execute studies from feasibility to close out, accountable for all study budgets, documents, drug supply, and plans with 3-year horizon
- Select countries and sites based on Clinical Development Plans and global Strategies
- Conduct program level feasibility and develop recruitment plans
- Actively lead cross functional team and attend Clinical Sub Team/Project Team meetings as needed to represent Clinical Operations
- Create and maintain performance and quality metrics
- Contribute clinical information for Regulatory submissions and responses
- Proactively identify risks and devise mitigation plans
- Expert in complex vendors and relationships
- Select CRO, other vendors, manages Scope of Work (SOW), scope changes, budgets, approve all vendor payments. Ensure that CRO has strategic direction for protocol(s)
- Hold vendors accountable to Scope of Work (SOW)
- Responsible for contributing to and delivering study and therapeutic area training for team and vendors
- Accountable for Investigator Meetings, oversee planning
- Accountable for ensuring data quality and timely data reviews conducted
- May attend qualification or Site Initiation Visit
- Develops and drives site engagement strategy
- Highly skilled communicator, builds & maintains strong relationships internally and externally
- Drive protocol & amendments Investigator Brochure, Informed Consent Form, monitor plans, risk management
- Reviews clinical sections of other regulatory documents e.g. annual or periodic safety reports, IND/NDA filings for quality and consistency
- Build compelling, data driven case, clearly articulates vision to business partners, CROs, etc
- Provides supervision, coaching and mentoring to new study leaders, CTMs and Associates
- Responsible for growth, development, and promotion of full time direct reports using development planning tools. Contribute to hiring of new staff.
- Master of Clinical operations, can lead any study and is a protocol expert
- Understand and apply knowledge of science/biology, e.g. cardiology, mechanism of action of drug to planning and all phases of the study
- Seek to stay current with new advances, competition
- Accountable for complete Trial Master File and training of study team, internal and external business partners
- Directly supervises 1-3 employees
- May be responsible for external consultants
- MS/MA degree in related discipline desired.
- Typically requires a minimum of 8 years of related experience and/or combination of experience and education/training research in the biotechnology/pharmaceutical industry.
- Experience in the operational aspects of managing phase 1-3 clinical studies from start-up to closeout, vendor management, and planning cross-functional operational activities.
- Experience developing trial plans including, site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management.
- Thorough clinical research knowledge and cross-functional understanding of clinical trial methodology is required.
- Knowledge of ICH-GCPs and 21 CFR is required.
- May lead or oversee the work of others by providing direction and by using established policies and precedents.
- General project management skills with the ability to organize, prioritize and manage numerous tasks and complete them under time constraints.
- Ability to apply strong analytical, business and communication skills, as well as technical standards, principles, theories, concepts and techniques.
- Proficient with broad use computer applications such as MS Office and specialized applications as needed for job.
- Ability to travel up to 25%
- Performs job duties with minimal guidance from supervisor.
- Works on problems of complex scope where analysis of data requires evaluation of identifiable factors.
- Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
- Creates formal networks involving coordination among groups.
- Patients first
- Passion for science
- Succeed together
- Imagine and innovate
- Lifelong learning