Director/Senior Director, Clinical Data Management (Hybrid)

Qualifications

• On-site x3/4 days weekly
• Bachelor's degree or higher in life sciences, statistics or related field
• Minimum of 10 years' experience working within clinical data management
• Specifically with oncology studies and/or cell therapy (CAR-T)
• Strong understanding of FDA/EMA regulations

Skills

• Ability to manage multiple complex tasks simultaneously while maintaining attention-to-detail.
• Excellent communication skills both verbally and written; ability present information effectively across internal & external stakeholders including senior leadership.

Responsibilities include but not limited to,

• You'll be the first in the department, starting as an IC and building out the department over the next 18/24 months.
• Manage all aspects of global Oncology/CAR T-cell Therapy trials end-to-end ensuring quality standards met/exceeded whilst delivering against key business metrics.
• Responsible for providing strategic vision/direction regarding study design/collection/reporting/presentation/archiving activities critical path timelines /budget planning.
• Establish processes/systems that support effective collection/review/data query resolution/discrepancy reporting necessary ensure timely/high-quality database locks/documentation audit readiness contribute submission-related deliverables required regulatory filings globally.
• Work closely with other departments and external vendors to provide oversight/key monitoring responsibilities.

Desired Skills and Experience

Qualifications

• On-site x3/4 days weekly
• Bachelor's degree or higher in life sciences, statistics or related field
• Minimum of 10 years' experience working within clinical data management
• Specifically with oncology studies and/or cell therapy (CAR-T)
• Strong understanding of FDA/EMA regulations

Skills

• Ability to manage multiple complex tasks simultaneously while maintaining attention-to-detail.
• Excellent communication skills both verbally and written; ability present information effectively across internal & external stakeholders including senior leadership.

Responsibilities include but not limited to,

• You'll be the first in the department, starting as an IC and building out the department over the next 18/24 months.
• Manage all aspects of global Oncology/CAR T-cell Therapy trials end-to-end ensuring quality standards met/exceeded whilst delivering against key business metrics.
• Responsible for providing strategic vision/direction regarding study design/collection/reporting/presentation/archiving activities critical path timelines /budget planning.
• Establish processes/systems that support effective collection/review/data query resolution/discrepancy reporting necessary ensure timely/high-quality database locks/documentation audit readiness contribute submission-related deliverables required regulatory filings globally.
• Work closely with other departments and external vendors to provide oversight/key monitoring responsibilities.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

To find out more about Real, please visit www.realstaffing.com