Senior Manager, Data Management
MindMed
full-time
Posted on:
Location Type: Remote
Location: Remote • 🏈 Anywhere in North America
Visit company websiteSalary
💰 $155,313 - $177,500 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- 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
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!
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical data managementdatabase builddata reviewdata cleaningSAE reconciliationdata management planCRF designUATePROeCOA
Soft skills
leadershipteamworkcollaborationcommunicationtime managementadaptabilityindependenceproblem-solvingattention to detailprocess improvement
Certifications
Bachelor's degreeICH-GCP certification