Our Client is looking for experienced and dynamic Manager, Data Management who will be a part of the Data Management group. This role is focused on expert oversight on DM deliverables and strong E2E leadership together with CRO vendor management component. Main role’s purposes are accountability and leadership of the data management components for series of clinical studies/ projects focused on high quality standards and consistency across all study phases.
- Oversight/direction of end-to-end data management for a series of studies, delivered by DM Functional Service Provider (FSP).
- Study level contribution as Manager, Data Management, working in close collaboration with other key members of the internal and external study team.
- Point of contact for data management and data quality considerations for the company and CRO stakeholders
- Providing input to protocol and other company’s plans, e.g. Monitoring Plan, Protocol Deviation Management Plan, Reporting & Analysis Plan and Data Management Plan (or equivalent), during the planning phase.
- Management of in-stream data flow activities, with accountability of clean database delivery in accordance with the Data Management Plan or equivalent.
- Provides expert opinion into the data capture tools design, including eCRF and eCOA devices
- Providing input into the development and aid in the management and execution of the validation and integration plans, including dataset definitions and external data sources.
- Managing vendor performance against study-specific Service Level Agreements.
- Responsibility for the set-up and maintenance of TMF section 10 and DM TMF artefacts throughout the study life cycle.
- Training monitors and site staff on use of data collection tools and query management process.
- Where a study is outsourced to FSO/FSP partner, providing oversight and assuring FSO/FSP partner delivers to agreed quality, timelines and cost. What skills and expertise you will bring to the role:
- Relevant education degree from Scientific Discipline (Biomedical or Computer).
- Min. 4 years of data management/ clinical trials experience in Pharma, CRO and/or ARO
- Knowledge of the principles of quality, safety, risk management and compliance (ICH and GCP).
- Fluent English, both spoken and written.
- Understanding of laboratory data including biomarker data.
- Experience of InForm, RAVE and/or Veeva EDC systems will be an advantage.
- Experience working with key global preferred suppliers/ partnerships, to ensure deliverables are to the agreed standard.
- Demonstrated discipline of project management to plan, organize and manage activities to deliver specific study goals and objectives to measurable targets.
- Good communication skills, verbal and written, ability to effectively communicate and maintain strong working relationships in global teams at all levels of the organization.
- Result-driven, proactive, detail-oriented, problem solver.
The company values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. We also offer a wide range of additional benefits:
- Career at one of the leading global healthcare companies.
- Contract of employment.
- Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit).
- Life insurance and pension plan.
- Private medical package with additional preventive healthcare services for employees and their eligible.
- Sports cards (Multisport).
- Possibilities of development within the role and company’s structure.
- Personalized learning approach (mentoring, online training’ platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external training).
- Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities).
- Supportive community and integration events.
- Modern office with creative rooms, fresh fruits every day.