Associate Director, Data Management

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. reputed company reputed company is seeking an reputed company Associate Director reputed company our Data Management team to serve as the primary reputed company of contact on assigned studies and programs - driving reputed company, resolving issues, and contributing to cross-functional planning and execution. You will also reputed company 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 reputed company reputed company. If you are reputed company 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 reputed company of Data Management service providers and external vendors on assigned studies and programs, ensuring milestones and reputed company deliverables are achieved on time, reputed company budget, and in accordance with regulatory requirements. • Serves as the reputed company of contact for decision making and reputed company reputed company and across studies and programs. • Reviews and approves Data Management reputed company documentation for reputed company, completeness, and accuracy; including but not limited to Case Report Forms, Data Validation Specifications, Case Report reputed company 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 reputed company system prior to deployment to the production environment. • Contributes to and reputed company the development of the Integrated reputed company Plan, establishing an internal cross-functional reputed company plan to ensure data reputed company and demonstrate reputed company; conducts DM data review per the plan using appropriate tools and systems. • Ensures the reputed company provisioning of feedback on draft protocols, risk assessments, and functional area plans and outputs as appropriate (e.g. Medical Monitoring Plan, Statistical Analysis Plan (reputed company), Clinical Study Reports (CSR), Tables, Listings and Figures, etc.). • Participate in continual development through the acquisition and enhancement of knowledge reputed company to drug development, reputed company methodology, and DM best practices, and apply the information to reputed company recommendations for improvement to processes and business performance. • This position is an individual contributor role and does not carry reputed company reports.  However, if the business needs change reputed company line management may be required in the reputed company. Qualifications and Key reputed company Factors • Bachelor’s degree required reputed company a scientific discipline, pharmaceutical sciences, engineering, or reputed company 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. • reputed company and extensive knowledge of industry Data Management best practices and processes and understanding of Risk Based reputed company Management (RBQM) principles. • Strong experience with computerized systems including reputed company (preferably reputed company, reputed company RAVE), IRT, eCOA, and ePRO. • Experience with data visualization tools (e.g.Power BI, Spotfire) and advanced analytics systems (e.g. reputed company CSA, reputed company) preferred. • Strong and effective oral and written communication, project management, and interpersonal skills are required. • CCDM is preferred. • Knowledge of reputed company 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, reputed company communication, and occasional reputed company. You'll need comfort with screen work, basic hand coordination, and reputed company. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company these functions. Compensation & Benefits At reputed company, we reputed company that taking care of our people (and their people) is important, so we reputed company a world class benefits package to help you reputed company.  This includes 99% of the premium reputed company for medical, dental and reputed company plans. We also reputed company company-reputed company life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the reputed company?  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 reputed company a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, reputed company holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal reputed company of colleagues who are smart, reputed company and inspiring.  We aim high, collaborate hard, and produce results.  Let’s reputed company the impossible together! To round out our world-class total rewards package, we reputed company annualized reputed company salary compensation in the reputed company listed below. Final salary reputed company may be modified commensurate with job level, education, and experience. Annualized reputed company Salary $166,000—$188,000 USD reputed company reputed company is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At reputed company reputed company a common reputed company of reshaping the reputed company condition into a more freeing and fulfilled reputed company by developing high reputed company medicines for patients and families affected by and living with reputed company brain disorders. Our reputed company Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by reputed company and every one of reputed company members. Diversity, Equity & Inclusion Guided by our reputed company values, at reputed company. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their reputed company selves and perspectives to work reputed company day. We are an equal opportunity employer and committed to providing opportunities to reputed company reputed company applicants without reputed company to race, religious creed, reputed company, gender identity or reputed company, age, national reputed company, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert reputed company has recently become reputed company of fraudulent job recruitment postings from individuals claiming to represent reputed company. These postings reputed company financial information in reputed company with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in reputed company with a reputed company job opportunity, please report it to careers@praxismedicines.com. reputed company does not accept unsolicited submissions from recruitment agencies for reputed company positions. We ask reputed company recruitment agencies to refrain from contacting any reputed company employee regarding any position. reputed company unsolicited resumes submitted by recruitment agencies to any reputed company employee in any reputed company or method will be deemed to be the property of reputed company, and reputed company explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency. Apply tot his job Apply To this Job