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
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