Director Clinical Operations Study Management

Director Clinical Operations Study Management

Salary: $225,000 - $245,000

New York City or Jersey City (Hybrid)

Job Description

Founded by a team of noble prize winning scientists, EPM is partnered with one of the most exciting and cutting edge biotech companies in the industry. They have raised over $1 billion dollars of funding to advance their pipeline of 7 programs and are gearing up for their first Phase 3. Focusing in oncology, they are using a first of it's kind drug discovery platform that has allowed them to create the most innovative drugs ever seen.

Responsibilities

• Responsibility for the overall management of assigned clinical programs across multiple studies
• Providing strategic direction to study teams to ensure timely execution of clinical trials
• Have a key role in hiring/resourcing plans, program budgets, hiring process of study team
• Responsible for day-to-day management of assigned direct reports
• Oversight of CRO and other key vendors to ensure timely and quality deliverables
• Act as point of escalation for clinical trial execution issues
• Oversight of the set-up and implementation of effective investigator and site monitor training
• Leadership and implementation of infrastructure initiatives, process improvements, change management, and business projects
• Oversight of the clinical aspects of timely data cleaning, data analysis, and the availability of top line resutls

Qualifications

• Bachelor's degree required
• 12+ years of experience working with CROs to manage large scale global clinical trials
• Oncology experience is required
• 4+ years of experience managing direct reports, displaying strong leadership, team building, and hands-on management
• Comprehensive understanding of ICH and GCP guidelines, as well as applicable regulations and practices
• Effective communication and interpersonal skills
• Excellent organizational skills and attention to detail
• Able to work independently while exercising initiative, flexibility, and sound judgement
• Experience monitoring all types of data

Benefits

• Medical
• Dental
• Vision