Senior Manager, Data Management

Responsibilities

• In collaboration with Clinical Sciences, Biostatistics, Clinical Operations, and other key Development functions, responsible for the design of clinical trial databases, which includes, but not limited to, CRF Development, Database Validation, and Data Review tools in accordance with ICH/GCP guidelines and current regulatory requirements.
• Oversee external data management vendors in respect to key performance indicators, metrics, program level deliverables, timelines, and budgets; may participate in vendor selection activities.
• Optimize data management and collection activities by reviewing protocols for cross-trial consistency and identifying standard case report form modules.
• Maintain current knowledge of relevant issues related to data management, Health Authority regulations, and competitive trends to provide input and recommendations.
• Propose, draft, and maintain relevant Standard Operating Procedures and other policies and procedures relevant to the department; may participate in systems selection and implementation activities.

Qualifications

• Bachelor’s degree in a scientific, medical, computer science or related field; Master’s degree preferred.
• A minimum of 5 years’ management level experience in a pharma or biotech environment.
• Strong experience in data management-related activities, with thorough understanding of the clinical trial process and regulatory requirements, including CDISC.
• Strong experience in design and validating EDC databases and performing data review; familiar with safety laboratory data management and dictionary coding for adverse events and medications.
• Experience in CNS, pediatric rare disease area and e-diary database design and implementation are preferred.
• Experience in CRO management.
• Ability to be hands-on with database cleaning, generate patient level listings as needed.
• Excellent leadership and interpersonal skills, ability to build credibility and trust inside and outside the Company.
• Proven ability to collaborate in high performing teams, excellent conflict resolution skills.
• Be science and data driven while at the same time, be creative and flexible in strategic thinking and problem solving.
• Ability to travel up to 10%, both domestically and internationally.