Senior Clinical Data Manager Job Description Template
Our company is looking for a Senior Clinical Data Manager to join our team.
Responsibilities:
- Perform/document user access testing for clinical data capture systems or visualization tools;
- Oversee vendor performance, quality, and deliverables;
- Participates and represents function in formal inspections and audits as requested;
- Establish asset and study level strategies and services, including excellence in the application of standards;
- Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents;
- Supervise data reconciliation activities with Safety database and external data vendors;
- Contributes to the management of vendor partnerships to maximize effectiveness and maintain budgets;
- Serves as a clinical data management expert and provides guidance on CDISC standards;
- Conduct oversight using, predictive data monitoring practices from database activation through database release and submission;
- Strong focus on TMF documentation and inspection readiness;
- Manage assigned DM timelines and priorities;
- Perform data quality review for quality issues and general data trends;
- Act as an internal expert for CRO processes as well as overall data management expert;
- Provides and enables solutions for complex problem solving.
Requirements:
- Strong working knowledge of (e)CRF design and data management functions/activities as applied to standards library development and maintenance;
- Advanced knowledge of office software (Microsoft Office);
- Proven track record of strong project management skills and experience managing data management activities for large drug development programs;
- 5+ years of Clinical Data Management experience;
- Ability to work effectively in a global environment;
- Strong collaboration skills regarding external and internal teams, and working in a cross- functional team environment;
- Demonstrated ability to prioritize work;
- 2 years of experience should demonstrate full responsibility as a Study Data Manager;
- Highly organized with a strong attention to detail, clarity, accuracy and conciseness;
- Detail oriented individual with a sufficient knowledge of clinical research/development operations in order to execute relevant data management;
- Must have excellent written and verbal communication skills;
- Experience in CRO and vendor management required;
- Experience with all aspects of DM including Database Build, Study Startup, Study Conduct and Database Closure activities;
- Significant experience in using data management methodologies;
- activities independently.