Associate Director, Data Management - United States - Remote

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. · The Opportunity · Praxis is seeking an experienced Associate Director within our Data Management team to serve as the primary point of contact on assigned studie ...

Job description

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

Praxis is seeking an experienced Associate Director within our Data Management team to serve as the primary point of contact on assigned studies and programs - driving decisions, resolving issues, and contributing to cross-functional planning and execution. You will also oversee the performance of external data management partners for assigned studies and programs. This is a hands-on role requiring strong judgment, technical expertise, and a collaborative mindset. If you are energized by building fit-for-purpose systems, navigating complexity with curiosity and ownership, and working at a company where patients come first, we'd love to meet you.

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.
• This position is an individual contributor role and does not carry direct reports. However, if the business needs change direct line management may be required in the future.

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.
• CCDM is preferred.
• Knowledge of SAS and database programming, systems integration experience and understanding of CDASH and CDISC standards are preferred.
• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let's achieve the impossible together

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below. Final salary range may be modified commensurate with job level, education, and experience.

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.

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