Lead Data Manager
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.
Working at Premier Research means being an individual - you will be recognised for what you do and you will truly have an impact.
You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.
Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
We’re looking for a talented and energetic Lead Data Manager to join our team in our Warsaw office.
You'll be accountable for:
- Interacting with the Project Manager on a continual basis throughout the course of the study
- Coordinating and acting as point of contact for all data operations responsibilities related to data management for multiple studies when designated as the Lead Data Manager (LDM) for the Premier Research project team
- Overseeing the preparation of data management plans, data entry guidelines, data management reports and other documents required for preparing and completing databases, when requested
- Reviewing draft protocols and CRFs for potential data collection and representation, database structure or data entry problems, and provides feedback to the project team, when requested
- Mentoring newly hired Associate Data Coordinators or Data Coordinators
- Reviewing CRFs, data listings, and database to ensure all captured data follow the rules outlined by the protocol and data management plan
- Generating paper and electronic queries to appropriate internal or external personnel (investigational sites, vendors, Clinical Research Associates (CRAs), client representatives) to resolve problematic data identified during every aspect of the data management process
- Reviewing responses to queries for appropriateness, resolving any discrepancies and modifiying the database accordingly
- Tracking CRFs as they are processed through the Data Management department
- Ability to act as a data management core team lead for multiple projects
You'll need this to be considered:
- Minimum of a Bachelor's Degree (or equivalent) preferably in science, engineering, or mathematics
- Prior experience in clinical data management
- Experience within Medidata RAVE or DataLabs
- Experience in bid defenses is preferred
- Expertise in ICH/GCP and/or ISO14155 requirements as well as detailed knowledge of the relevant country specific regulatory requirements for conducting clinical trials. Knowledge of site and institution specific contract requirements
- Clinical trials support or pharmaceutical industry experience required
- Works with internal and external customers/vendors to meet project specific goals.
- Identifies, monitors, documents, and tracks out-of-scope activities.
- Proficient in the development and review of Informed Consent Form templates
- Fluent verbal and written English as well as the local language(s)
- Excellent team player, collaborative and able to build an effective team
- Ability to multitask and work effectively in a fast-paced environment with changing priorities
- Excellent organizational and time-management skills, able prioritize work to meet deadlines
- Accountable, dependable and strong commitment
- Is customer service focused in approach to work both internally and externally
- Maintains a positive, results orientated work environment
- Available to travel up to 20%