Clinical Data Management Manager
Company: Edelway Switzerland AG
Location: Vaud Area
Closing Date: 13 Feb 17
Salary (£): Competitive
Edelway is a pan-European Pharma Consultancy. One of our best clients, a global, pharmaceutical company based in Vaud Area, Switzerland is currently looking for experienced Clinical Data Management Manager.
- Training and mentoring of Data Management TA staff on processes, projects and programs.
- Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting Data Management.
- Participate in and/or lead Data Management and cross functional working groups.
- Contribute to the continuous improvement of DM and the wider Development organization through information sharing, training and education.
- Contribute to development of Data Management outsourcing strategies and long-term relationships with CRO partners / external vendors.
- Promote and be an advocate of Data Management internally and externally.
- Represent DM at project team meetings i.e., GCST.
- Project level coordination of and day to day oversight of Data Management tasks including.
- Co-ordination of lead Data Management within the project.
- Review of all Data Management documents within a project area to ensure a consistent approach.
- Overview of project timelines and metrics to ensure databases are delivered to set timelines.
- Approve database locks and unlocks.
- Ensure that quality control checks are occurring such that quality databases are delivered.
- Develop and co-ordinate project level training for data management staff.
- Review and approve study specific training.
- Manage vendor deliverables and relationship at the project level.
- Communication and escalation of project level issues including processes, timelines, resourcing, performance, etc.
- Review of all study level non DM documents for awareness and project level consistency.
- Lead electronic submission activities.
- Assist with response to questions and findings from Clinical Quality Assurance and other audits at the study / vendor level.
Qualifications and Experiences:
- Doctorate degree. OR
- Master’s degree & 3 years of clinical experience. OR
- Bachelor’s degree & 5 years of clinical experience. OR
- Associate’s degree & 10 years of clinical experience. OR
- High school diploma / GED & 12 years of clinical experience.
If this sounds like your next challenge please send us your CV at firstname.lastname@example.org