Senior Manager, Data Management

Summary

Join MindMed, a clinical-stage biopharmaceutical company, as a Senior Data Manager! You will oversee outsourced clinical studies, manage data management deliverables, and ensure high standards of cost, quality, and timelines. Responsibilities include managing external data sources, integrating data into MindMed's database, and collaborating with cross-functional teams. This 100% remote position requires a Bachelor's degree, 5+ years of clinical data management experience (including 1+ year as a DM lead), and proficiency with Medidata Rave. The ideal candidate will possess additional skills in data analysis, various data platforms, and programming languages. MindMed offers competitive benefits, including 100% paid health benefits, a 401(k) program, flexible time off, and generous parental leave.

Requirements

• Bachelor's degree or equivalent
• 5+ years of direct experience in clinical data management within the biotech or pharmaceutical industry with at least 1 year as a DM lead
• Proficient with Medidata RAVE platform, with other EDC platforms considered (InForm, Oracle Clinical, or similar) and IRT, with strong understanding of database design, database concepts and related processes (database builds, updates, locks, etc.)
• Knowledge of ePRO/eCOA instruments and their use in clinical studies
• Working knowledge of CDSIC Standards
• Knowledge of international guidelines (ICH-GCP) for the conduct of clinical research projects
• Knowledge of compliance, privacy, and safety pertinent to real-world data analytics
• Ability to multi-task, work independently, and act with appropriate accountability
• Readily adapt to new environment, technologies, and processes
• Strong teamwork and collaboration skills
• Excellent written and verbal communication skills

Responsibilities

• Serve as DM lead managing assigned study project(s) ensuring overall deliverables/timelines and vendor responsibilities are met and providing oversight of CROs, and other vendors including DMPs, CCGs, DTAs etc
• Represent Data Management on cross-functional study teams
• Oversee multiple concurrent studies while participating in special projects or process improvement initiatives
• Translate clinical protocols into electronic case report forms and develop in conjunction with CRO DM the associated data validation specifications (eg, edit checks, custom functions and reports)
• Work with multiple external data vendors and facilitate importation of multiple data types into MindMed’s database, including elluminate®
• Facilitate UAT for database builds and migrations to manage any impacts from mid-study updates to the EDC database and other data collection systems
• Perform data reviews for quality issues, identify general data trends and facilitate data review meetings with relevant cross-functional team members
• Develop technical specifications for data management programming and communicate needs to data management and other technology partners
• Perform ongoing review of study documentation in the trial master file (TMF) to always ensure audit readiness
• Participate in Protocol Deviation review meetings and other data cleaning activities

Preferred Qualifications

• Experience in data management or analysis using biomedical/patient health data/real world data/clinical data/novel data streams
• Experience with Data hub platform and interfaces
• Experience in manipulating large amounts of data
• Experience working with privateb and sensitive personal information
• Medidata Rave build certification
• Experience with data visualization tools (eg, TIBCO Spotfire, elluminate®, Power Bl, Tableau, SAS JMP etc.)
• Computer programming skills in Python/Pyspark, R, SQL
• Experience with cloud and high-performance computing environments (AWS, GCP)

Benefits

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match and immediate vesting
• Flexible time off
• Generous parental leave
• Bonus and equity
• 100% remote position with ~10% travel requirement based on business needs