Definium Therapeutics · 22 hours ago
Senior Director, Clinical Data Management
United States
Full-time
Remote
Director/Executive
$233K/yr - $276K/yr
18+ years expDefinium Therapeutics is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. The Senior Director, Clinical Data Management will be responsible for the clinical data strategy and quality across all clinical programs, ensuring alignment with design objectives and supporting data analysis.
Biotechnology
Responsibilities
Provide managerial and technical leadership for the Data Management group within the Dept of Biometrics and Data Science; coach and grow direct reports and build a team of high collaboration and productivity
Ensure all data management activities supporting clinical trials, from building study databases, collecting and cleaning data as the trials are ongoing, to achieving study database locks, are delivered of high quality and meeting timeline
Oversee DM vendors and/or data collection vendors' deliverables from quality to timeline while maintaining mutual respect and strong collaboration
Examine and ensure an effective and efficient data review/cleaning process to prepare for clinical trial database lock by leading multi-functional effort, including Clinical Operations, Clinical Development and Medical, to participate in thorough data review
Serve as a lead Clinical Data Management for one or two clinical programs as needed
Provide input to protocol development and provide input to other clinical study documents and/or regulatory filing dossier as needed
Responsible for data management budget creation, management, and invoice review
Create procedures and processes that delineate accountability and responsibilities of different functions who are involved in clinical trial data collection, review and cleaning
Create necessary SOPs and guidance to ensure data management activities are compliant from quality standpoint and DM related documents are compliant with the trial master file (TMF)
Partner with Biostatistics, Statistical Programming and Data Science colleagues to build an organization of mutual trust and strong collaboration to achieve common goals
Qualification
Required
Master's degree with 18+ years of experience in clinical data management within the biotech or pharmaceutical industry
13 + years of experience in managing Data Management group
Strong track record in building the team, growing direct reports, and taking team's performance to the next level
Extensive hands-on experience in performing DM activities from database design, data review/cleaning to database lock
Solid knowledge in clinical trial data management processes, tasks, and tools; familiarity with CDSIC standards
Strong track record in managing DM vendors to resolve data issues and achieve quality study database lock
CNS trial data management experience or solid experience in ePRO/eCOA data collection with good understanding about statistical analysis approaches for CNS clinical trials
Deep understanding of regulatory guidance, quality compliance, and data privacy pertinent to clinical trial participants
Demonstrated capacity of collaboration with Clinical Operations, Clinical Development, Medical, Biostatistics and Statistical Programming, and relevant functions to achieve common goals
Strong organizational and project management skills; demonstrated interest in continued learning and growing
Detail-oriented and hold high standards of excellence for own work products
Deliver and communicate effectively in the work-from-home environment
Excellent interpersonal skills and is a good team player
Preferred
Experience with data visualization tools (e.g., Elluminate)
Programming skills to generate data listings that can assist in revealing data issues (e.g., experience of using Python)
Benefits
100% paid health benefits including Medical, Dental and Vision for you and your dependents
401(k) program with company match and vesting after the turn of the first month after your start date
Flexible time off
Generous parental leave and some fun fringe perks!
Company
Definium Therapeutics
Definium Therapeutics (formerly MindMed) is a biotech company forging a new era of psychiatry by applying precision to psychedelic medicine.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase