Director, Clinical Trials

The Director of Clinical Trials oversees the planning, execution, and management of clinical research studies to ensure they meet regulatory requirements, company goals, and industry standards. This leadership role is responsible for directing cross-functional teams, managing budgets and timelines, ensuring compliance with GCP (Good Clinical Practice), and liaising with regulatory agencies, sponsors, and other stakeholders. 

Duties & Responsibilities:

• Identify new clinical trial and partnering opportunities for CortiCare EEG Services
• Prepare budgets, proposals and RFPs to secure clinical trial opportunities
• Develop project plans in collaboration with potential clinical trial partners
• Draft project plans, statements of work, and internal regulation documents needed for clinical trial resource planning
• Lead the Project teams to ensure that Client Trial requirements and deliverables are achieved
• Assist with the study costing and contract requests and be accountable for financial tracking and reconciliation of projects with the internal accounts payable and finance departments
• Collaborate with external Lead Scientists to ensure projects are conducted in compliance with appropriate protocol, Standard Operating Procedures (SOPs) and regulatory agency guidelines, in a timely, efficient, and quality manner
• Work with internal and external stakeholders to collect and conduct analyses of the competitive landscape data to inform Executive Management for internal strategic planning

Expectations: 

• Comply with applicable laws, regulations, guidelines and standards regarding Safety and infection control issues
• Follow CortiCare Policies, Procedures, Guides and Workflows
• Communicate clearly and effectively with team members using Text, Qliq, E-mail and mobile phone calls regarding problems
• Independent, proactive and self-driven with a can-do attitude
• Dedicated to science, medicine, and the opportunities in neuroscience business overall

Qualifications: 

• Demonstrate effective written and spoken communication skills
• Excellent consensus-building skills and experience working with cross-functional teams
• Maintain CPR credentials 
• Ability to independently set and meet deadlines and motivate others to meet deadlines

Education and Experience:

• Maintain ABRET R. EEG T. credential
• Bachelor’s degree preferred, but not required
• 5-10 years experience in clinical research or a related field
• 2-3 years of experience leading cross-functional teams and managing vendor partnerships

Physical Requirements:

• Prolonged periods of sitting at a desk and working on a computer