The Clinical Data Management Director is a highly experienced and influential leader with expert knowledge of Clinical Data Management concepts and processes. This position is accountable for the operational leadership of CDM activities across all solid tumor oncology clinical studies Phase I to IV.
Requirements
- BS/BA degree in related discipline and a minimum of 13 years of related experience
- MS/MA degree in related discipline and a minimum of 11 years of related experience
- PhD in related discipline and a minimum of 8 years of related experience
- Experience in Biotech/Pharmaceutical industry required
- Experience in Oncology clinical trials is preferred
- Experience leading change initiatives is preferred
- Demonstrated experience leading global data management activities is required
- Experience participating in regulatory submissions and inspections is required
- A minimum of 8 years of leading teams in a highly matrixed organization
- Excellent understanding of clinical development, quality and regulatory standards (e.g., CDISC) and policies relevant to Data Management and risk based data management approach of clinical data (e.g., GCP, ICH)
Benefits
- Comprehensive employee benefits package
- 401k plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Sales-based incentive plan
- Opportunity to purchase company stock
- Long-term incentives
- 15 accrued vacation days in their first year
- 17 paid holidays including a company-wide winter shutdown in December
- Up to 10 sick days throughout the calendar year