Data Manager

April 18

MindMed

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MindMed is a clinical-stage biopharma company developing novel products to treat brain health disorders

51 - 200

💰 $30M Post-IPO Equity on 2022-09

Description

• 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 • 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 (e.g., edit checks, custom functions and reports) • Work with multiple external data vendors and facilitate importation of multiple data types into MindMed’s database • 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.

Requirements

• Bachelor's degree or equivalent • 3+ years of direct experience in clinical data management within the biotech or pharmaceutical industry • Proficient in multiple EDC platforms (InForm, RAVE, 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

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 and some fun fringe perks!