Project Data Manager
Ian Marlow at CK Clinical is looking for a permanent Project Data Manager for a Pharmaceutical company that's currently bucking the industry trend and investing heavily in the UK.
Job Summary: Responsible for the global planning, organization and coordination of data management activities in a project; ensures overall database consistency across all studies within a project; manages all activities centred around CRF design, data collection, data retrieval, global integrated database development, coding and query management for PoC to Phase 4 clinical trials; oversees, monitors, and evaluates all interactions with external vendors (CROs); and ensures data management standards and quality are maintained and implemented.
Responsibilities: Oversees all project related Data Management activities, including but not limited to: CRF design, data collection, edit checks, consistency of data collected across investigative sites, query management, data quality control, medical coding, SAE reconciliation between clinical trial and drug safety databases, quality audits of the database against data collection instrument sources, database locks, and archival of Data Management deliverables and documents
Primary contact for all project teams, domestic and global, to ensure data quality and timely database delivery
Reviews Data Management performance against established metrics in a Data Management Performance Report, prepared at the conclusion of each study.
Ensures that a complete archive of Data Management documents and records is maintained at the site in accordance with applicable company and regulatory guidelines
Evaluates contracted regional CROs on an ongoing basis to determine if they fulfil requirements of SOPs (including Working Policies (WPs)), timeliness, and quality.
Evaluates candidate CROs and external vendors as to their ability to adhere to company SOPs (including WPs), and quality standards before any outsourcing contract is finalized.Manages database and supporting documentation archival to meet long-term regulatory requirements.
Demonstrates core competencies at the management level; exhibits company values.
Ensures that all project related outsourcing agreements are comprehensive and complete.
- MS; BS/RN in life sciences
- A proven track experience within pharmaceutical/data management (Project management experience preferred)
- Good oral and written communication skills.
- Proficient in Microsoft Office Suite including Word, Excel, and Project
- Good problem solving, analytical, organization, and time management skills
- Demonstrates initiative
- Works well in a team environment
- Demonstrated knowledge of clinical data flow and research design
- Clinical database administration and system validation experience
- Demonstrated competence with GCP/regional regulatory guidelines, SOPs (including WPs), medical terminology, standard coding dictionaries, and demonstrated proficiency in applying them to all relevant therapeutic areas.
For more information or to apply for this position, please contact Ian Marlow on 01438 743 047 or IMarlow@ckclinical.co.uk, or Stephanie Maccioni on 01438 768714 or SMaccioni@ckclinical.co.uk. Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL33782 in all correspondence.