Clinical Trial Leader

Location
Brisbane, California, United States
Posted
Oct 01, 2020
Ref
1069241698
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
SUMMARY: Acts as a clinical trial lead in one or more clinical studies. Develops, manages and coordinates all clinical trial activities for their studies including managing CROs, vendors and internal team members. Develops and applies best practices in the development, initiation, planning, execution, control and closing of projects. All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with the company's Standard Operating Procedures.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Scope of studies
  • Lead one or more studies


Study level planning and oversight
  • Plan and execute study from feasibility to close out, accountable for all study budgets, documents, drug supply, and plans with 1-2 year horizon
  • Select sites per clinical development plan
  • develops recruitment plans
  • Actively lead cross functional team, may represents clinical operations at other department meetings
  • Maintain performance and quality metrics
  • Contribute clinical information for regulatory submissions and responses
  • Proactively identify risks and devise mitigation plans


Vendor oversight
  • Developing expertise in complex vendors and relationships
  • Recommend CRO, other vendors, manages SOW, scope changes, budgets, approve all vendor payments
  • Ensures that CRO has strategic direction for protocol(s)
  • Holds vendors accountable to SOW


Site management
  • Responsible for study or therapeutic area training for team and vendors
  • Accountable for IMs, oversees planning
  • Accountable for ensuring data quality and timely data reviews conducted
  • May attend qualification or SIV
  • Drives site engagement strategy


Relationship and stakeholder management
  • Proficient communicator, builds & maintains strong relationships internally and externally


Clinical documents
  • Drive protocol, Investigator Brochure, ICF, 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


Negotiating and influencing
  • Is credible, can articulate clinical operations vision clearly to business partners, CROs, etc
  • Developing influencing skills to drive partner relationships and deliverables


Coaching and mentoring
  • Provides coaching and mentoring to CTMs and CTAs
  • Is developing people manager skills in preparation for future supervisor role at next level


Business and therapeutic knowledge
  • Advanced understanding of Clinical Operations, can lead most phases and study types
  • Protocol expert
  • Understands the science/biology, e.g. cardiology, mechanism of action of drug
  • Seeks to stay current with new advances, competition


Inspection readiness
  • Accountable for complete TMF and training of study team and internal/external business partners


Ability to travel
  • Up to 25%


Supervisory Requirements
  • May be responsible for external consultants


EDUCATION/EXPERIENCE/SKILLS:

  • BS/BA required.
  • MS/MA degree in related discipline desired.
  • Typically requires a minimum of 6 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.


Knowledge/Skills/Abilities:
  • Thorough clinical research knowledge and cross-functional understanding of clinical trial methodology is required.
  • Knowledge of ICH-GCPs and 21 CFR is required.
  • 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.


JOB COMPLEXITY:
  • 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.


VALUES:
  • Patients first
  • Passion for science
  • Succeed together
  • Imagine and innovate
  • Lifelong learning