Senior Data Manager
Alira Health
full-time
Posted on:
Location Type: Remote
Location: Massachusetts • United States
Visit company websiteExplore more
Job Level
Tech Stack
About the role
- Ensure DM tasks for the assigned studies are performed on time and within budget
- Partner with Sponsors, clinical and statistics to develop the data collection specification from all data sources
- Manage in-stream data flow activities and deliver a quality database in accordance with the project plan
- Lead and drive the DM team and act as the reference point for the Sponsor
- Provide Data Management input into the protocol
- Design the Case Record Form and guide process for CRF approval
- Define and develop the Data Management Plan, Data Validation Plan
Requirements
- Recent experience in using Medrio as Study Data Manager
- Degree in life science, pharmaceutical, biology or related field or at least 3 years’ experience in data management field or similar in a pharmaceutical environment or equivalent
- Knowledge of Data Management processes
- Good Knowledge of pharmaceutical industry guidelines like ICH, GCP etc
- Good Knowledge of coding dictionaries like MedDRA and WHO-DD or equivalent
- Good Knowledge in one or more DM systems
Benefits
- Professional development
- Global travel
- Flexible work programs
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
data managementdata collection specificationdatabase quality assuranceCase Record Form designData Management Plan developmentData Validation Plan developmentcoding dictionariesMedDRAWHO-DDDM systems
Soft Skills
leadershipcommunicationcollaborationorganizational skillsproblem-solving