Associate Director, Clinical Data Management - Remote

Overview

The Associate Director, Clinical Data Management is responsible for leadership and overall strategic management of data management of clinical Programs. The individual will serve as the lead data manager for clinical studies as assigned and is responsible for providing input to protocols, design and review case report forms, provide input to clinical database development and perform all data management related activities.

In Short

• Participates in collaboration and coordination with others to design and implement clinical protocols and data collection systems
• Reviews clinical, regulatory and other documents, as needed, to assure data integrity and quality
• Perform data management activities for both in-house and outsourced studies and manage timelines during study start-up, study conduct, database lock, and documentation archival
• Conduct oversight of data management CROs by ensuring data management documents and tasks are completed and delivered in accordance with timelines and data quality standards
• Oversee and drive development of study related data management deliverables (e.g., eCRF, DTA, etc.)
• Participate in the implementation and UAT of clinical systems (e.g., EDC, IRT)
• Coordinate cross functional data review and provide proactively review of data trends and issue resolution
• Oversees Clinical Data Management related study budgets including reviewing of initial study budget and handles the budget through the lifecycle of the clinical trial by communicating changes as appropriate
• Assists with the development of standards and process documentation, including Standard Operating Procedures and Work Instructions

Requirements

• Minimum of 12 years relevant experience, with 10 years data management experience in the pharmaceutical, biotech, or CRO industry
• Bachelor's degree is required
• Hands-on knowledge and experience in data management activities, CRF and EDC design, review, and validation from various vendors
• Knowledge of SDTM and experience in transforming raw data into these standards.
• Knowledge of GCP, ICH, and regulatory requirements
• Successful track record of both leadership and working independently in a matrixed organization and providing solutions to emerging problems
• Excellent interpersonal communication skills, along with organizational skills

Benefits

• The position will be based in our beautiful Irvine office, complete with a courtyard, snacks, drinks, and occasional catered meals. We provide a hybrid work environment. Remote work may be considered.
• We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
• This position reports directly to Director, Biostatistics
• Some travel may be required – up to 30%
• At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $142,500 - $199,500 plus bonus, stock equity, and comprehensive benefits.
• The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training.
• Our benefits include health, dental and vision insurance benefits to ensure your well-being.
• We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days.
• For more details regarding Tarsus benefits, please visit: https://alliantbenefits.cld.bz/25tarsusbenesnap.