Senior Manager, Data Management

MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health.   

Founded in 2019, we are continuously expanding our presence and global footprint. We are constantly searching for high-impact individuals in various clinical, technical and business operations domains to strengthen our team of patient-centric, intelligent individuals.

To support the continued growth of our clinical development capabilities, MindMed is seeking an experienced Senior Data Manager to oversee outsourced studies and be responsible and accountable for managing all Data Management deliverables at a consistently high standard concerning cost, quality, and timelines for all assigned indications within one or more Global Clinical Program(s)/Project(s).

Additionally, the position would involve managing external data sources and integration within MindMed’s database. They will also manage and catalog Clinical data assets, including historical and ongoing clinical trial data.

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.

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

Desired Skills:

• 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)

Working Conditions and Travel:

• This is a 100% remote position with ~10% travel requirement based on business needs.

The starting base pay range for this position is $123,592 - $150,000.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.

Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:

• 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!