Director/Sr. Director, Clinical Data Management (Must Have Biotech/Pharma Experience) - Scorpion Therapeutics

Scorpion Therapeutics is seeking a highly skilled and experienced Director/Senior Director of Clinical Data Management to lead our clinical data management efforts. The successful candidate will play a critical role in overseeing all aspects of clinical data management, from design to close out, to ensure the integrity, accuracy, and completeness of clinical trial data across all phases of development. This position will be integral in defining a vision for the Data Management team that appropriately balances the use of internal and Contract Research Organization (CRO) resources.

Key Responsibilities:

• Provide strategic leadership and direction for the clinical data management function, including oversight of a team of clinical data managers and/or CRO partners .
• Establish an end-to-end process for data management for all Scorpion Therapeutics clinical studies. Ensure the process is consistently implemented across all programs and studies and across all CROs and vendors with variations occurring where appropriate per study needs.
• Collaborate closely with cross-functional teams including Clinical Operations, Biostatistics, Regulatory Affairs, and Clinical Development to ensure timely and high-quality clinical trial data collection, cleaning, and reporting.
• Develop and implement data management strategies and processes to optimize data collection, cleaning, and reporting activities in compliance with regulatory standards and industry best practices.
• Oversee relationships with external vendors, including clinical research organizations (CROs) and data management vendors, to ensure the timely delivery of high-quality data management deliverables.
• Implement quality control processes and procedures to ensure the accuracy, completeness, and integrity of clinical trial data in accordance with regulatory requirements and company standards.
• Evaluate and implement data management systems and technologies to enhance data collection, cleaning, and reporting capabilities, ensuring alignment with company goals and objectives.
• Establishes goals, expectations, and accountabilities for staff, regularly reviewing DM team member performance with respect to quality and timeliness standards.
• Provide guidance, mentorship, and training to clinical data management staff to support their professional growth and development.
• Works in collaboration with QA and other functional groups to develop and update DM standard processes and procedures in accordance with CFR, GCP, ICH Guidelines and GCDMP minimum standards and best practices.
• Ensure compliance with relevant regulatory requirements, including Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and other applicable regulations and standards.

Qualifications:

• Bachelor's degree in life sciences, computer science, or related field; advanced degree preferred.
• Minimum of 10+ years of experience in clinical data management within the pharmaceutical or biotechnology industry.
• Demonstrated leadership experience, with the ability to effectively lead and manage a team.
• In-depth knowledge of clinical trial data management processes, standards, and best practices.
• Strong understanding of regulatory requirements governing clinical trial conduct and data management, including GCP and ICH guidelines.
• Experience with clinical data management systems (CDMS) and electronic data capture (EDC) technologies.
• Excellent communication, interpersonal, and problem-solving skills.
• Proven ability to work effectively in a fast-paced, dynamic environment with competing priorities.