Principal Clinical Data Manager
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Job Description
Principal Data Manager leading study management and delivery for pharmaceutical clinical trials. Collaborating with sponsors and stakeholders for quality project execution.
Responsibilities:
- Acting as oversight data manager for a program of studies, providing data management expert advice for clients and being the sponsor representative for DM oversight of vendors
- Acting as the study project lead / manager ensuring projects are managed and monitored so that client deadlines and deliverables are met.
- Liaising with Lead Programmer, Lead Statistician and Study Project Lead regarding resourcing and deliverables
- Leading DM teams for projects of significant complexity to ensure quality and timely deliveries on Phastar projects or client studies.
- Liaise with stakeholders to ensure successful project delivery
- Preparing stable draft eCRF specification for database build. Finalising eCRF specification and obtaining approvals.
- Performing QC of eCRF specification.
- Creating project level or therapeutic area level standards
- Preparing eCRF UAT scripts and performing UAT according to scripts.
- Creating standard CDASH eCRFs from a library
- Creating study specific / complex eCRFs. Checking protocol requirements are met.
- Approving release of database.
- Performing senior review summary of UAT findings for complex studies
- Specifying edit checks and performing senior review of the Data Review Conventions.
- Preparing edit check UAT scripts and performing UAT according to scripts.
- Programming study specific / complex edit checks
- Producing and reviewing data listings for data anomalies and performing sight review of eCRF data
- Reviewing edit check outputs and actioning as appropriate.
- Actioning data query responses.
- Raising manual data queries within the study database.
- Resolving issues arising with data queries
- Leading DM teams for projects of significant complexity to ensure quality and timely deliveries on Phastar projects or client studies.
- Liaise with stakeholders to ensure successful project delivery
- Being point of contact for DM issues for the team.
- Highlighting / giving feedback to relevant line managers regarding any performance of team members
- Providing expert advice for DM project innovation
Requirements:
- Life Science degree, nursing qualification or equivalent experience
- Experience within the pharmaceutical industry to have a good awareness of clinical trial issues, design and implementation, GCP and regulatory requirements
- Good experience of data management software systems and coding dictionaries including MedDRA and WHODrug
- Extensive experience of leading data processing activities within a regulated environment
- Experience with project management or resource management and working with budgets
Benefits:
- Phastar is committed to the principles and practices of equal opportunities and to encourage the establishment of a diverse workforce
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