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.
As a Senior Manager, Data Management, this role will be responsible for all clinical trial data related activities for the assigned clinical studies, early or late phase, as the lead study Clinical Data Management. This role will proactively participate in cross functional teams of internal clinical colleagues to manage external contract research organizations and other data vendors, drive end-to-end data quality and integrity from database creation, data quality review and cleaning, to deliver high quality database lock. This role will also be responsible for ongoing review of study documentation in the trial master file (TMF) and will contribute to the development of procedures or processes for the Biometrics department in MindMed.
Responsibilities:
- Function as an internal Lead Study Data Manager, independently overseeing all data management activities performed by CROs including database build, generation and review of metric status, and patient tracking reports to ensure major DM deliverables and milestones are delivered with high quality
- Represent Data Management on cross-functional study teams
- Oversee multiple concurrent studies while participating in special projects or process improvement initiatives
- Provide input to protocols and other clinical study documents during development; assist in review of vendor proposals, budgets, scopes of work
- Drive data management related study start up activities in collaboration with the CRO, including CRF design, manage sponsor’s database UAT, edit check specifications, data management plan, CCG’s and creation of vendor Data Transfer Agreements
- Manage all DM tasks as the clinical trial is ongoing, including data review/cleaning, SAE reconciliation, external data reconciliations, TMF plans, oversee migrations and database updates, review of protocol deviations, and oversee CRO’s DM team’s deliverables
- Play a critical leadership role in activities surrounding database lock to deliver high quality database lock meeting the timeline in collaboration with internal functions and the external vendors; tasks include final internal data review, queries closure, cross functional collaboration for issues’ resolution, and managing final external data transfers
- Perform ongoing review of study documentation in the trial master file (TMF) to ensure audit readiness
- Participate in development and implementation of departmental initiatives, review and provide input to SOPs and/or Working Instructions related to Clinical Data Management
Requirements:
- Bachelor's degree or equivalent
- 8+ years of direct experience in clinical data management within the biotech or pharmaceutical industry
- Experience working with DM vendors and CROs is highly desirable
- Proficient in Medidata Rave, RTSM
- Experience in ePRO/eCOA data collection and the execution of test scripts for UAT of ePRO/eCOA
- Working knowledge of CDSIC Standards
- Knowledge of international guidelines (ICH-GCP) for the conduct of clinical research projects
- Knowledge of compliance, data privacy, and safety pertinent to clinical trial participants.
- Ability to independently manage multiple tasks and deliver under tight timelines
- Readily adapt to new environment, technologies, and processes
- Strong teamwork and collaboration skills
- Excellent written and verbal communication skills
Desired Skills:
- Experience with data visualization tools (e.g., Elluminate)
- Medidata Cloud Admin experience
The starting base pay range for this position is $155,313.00 - $177,500.00. 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!
United States
