Clincial Data Manager - Project Manager
Utilize Data Management Expertise to Expedite Clinical Trials
Contribute to Approval of Innovative Medicines
- Leading full service global CRO, with high expertise in oncology and neuroscience
- Creation of management timelines related to data management operations
- Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations
- Provides project specific training to internal and external audiences as required
- Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed
- Monitors and communicates project/program progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management
Supports the management of resources on assigned projects/programs
- Plan, manages and requests resources for assigned projects
- Develop and maintain project plans, specifications and documentation in line with SOP requirements
- Maintains documentation on an ongoing basis and ensures that all TMF filing is up to date
- Participates in, and presents at internal, Sponsor, third-party, and investigator meetings
- Plans for and creates necessary documentation to support internal and external audits; participates in such audits
- Trains and mentors data management staff, acts as a subject matter expert
- Prepares input for, and participates in proposal bid defence meetings
- Maintains proficiency in Data Management systems and processes through regular training.
- Bachelors degree (Science, Engineering, Pharmaceutical Sciences)
- Extensive data management operations experience for clinical trials
- Experience in using EDC
- Smooth communication, business level English
- General knowledge about IT
- Knowledge about SAS programming
- Knowledge of CDISC standards
- Knowledge of biostatistics
- Work in an international environment, clear career development opportunities, contribute to global clinical studies
- Effective oral and written communication skills in Japanese and English.
- Strong presentation skills
- Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail.
- Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team.
- Ability to make effective decisions and manage multiple priorities in a highly dynamic environment.
- Knowledge of ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Management