Associate Director, Data Management

Primary Responsibilities

• Directly contributes to the oversight of Data Management service providers and external vendors on assigned studies and programs, ensuring milestones and quality deliverables are achieved on time, within budget, and in accordance with regulatory requirements.
• Serves as the point of contact for decision making and resolution within and across studies and programs.
• Reviews and approves Data Management related documentation for quality, completeness, and accuracy; including but not limited to Case Report Forms, Data Validation Specifications, Case Report Form Completion Guidelines, Data Management Plans, Data Transfer Agreements, Medical Coding Guidelines, User Acceptance Testing (UAT) documentation, Communication Plans, etc.
• Performs secondary User Acceptance Testing (UAT) of the EDC system prior to deployment to the production environment.
• Contributes to and oversee the development of the Integrated Oversight Plan, establishing an internal cross-functional oversight plan to ensure data quality and demonstrate oversight; conducts DM data review per the plan using appropriate tools and systems.
• Ensures the timely provisioning of feedback on draft protocols, risk assessments, and functional area plans and outputs as appropriate (e.g. Medical Monitoring Plan, Statistical Analysis Plan (SAP), Clinical Study Reports (CSR), Tables, Listings and Figures, etc.).
• Participate in continual development through the acquisition and enhancement of knowledge related to drug development, clinical trials methodology, and DM best practices, and apply the information to make recommendations for improvement to processes and business performance.

Qualifications and Key Success Factors

• Bachelor’s degree required within a scientific discipline, pharmaceutical sciences, engineering, or related field. CNS experience a plus.
• Requires a minimum of 5 years of Clinical Data Management experience in a pharmaceutical or CRO setting; 7+ years preferred
• Significant experience in managing outsourced data management activities.
• Thorough understanding of the drug development process, clinical trial methodology, regulatory requirements, and GCP.
• Current and extensive knowledge of industry Data Management best practices and processes and understanding of Risk Based Quality Management (RBQM) principles.
• Strong experience with computerized systems including EDC (preferably Medrio, Medidata RAVE), IRT, eCOA, and ePRO.
• Experience with data visualization tools (e.g.Power BI, Spotfire) and advanced analytics systems (e.g. Medidata CSA, CluePoints) preferred.
• Strong and effective oral and written communication, project management, and interpersonal skills are required.
• CDCM is preferred.
• Knowledge of SAS and database programming, systems integration experience and understanding of CDASH and CDISC standards are preferred.

Compensation & Benefits

• Annualized Base Salary: $166,000 - $188,000 USD

Company Overview

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.

Diversity, Equity & Inclusion

Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.