We are looking for a Data Manager (DM) who will provide management, technical consulting and support for the design, implementation and maintenance of our clients study databases/data repository. The DM ensures application integrity and recoverability of the databases and develops specific data management standard procedures.
Keeps senior technical management informed by preparing reports on system performance and problems.
Maintains good professional relationship with external vendors/CROs, peers, staff and management.
The DM oversees maintenance of database/data repository and ensures accuracy, integrity and completeness of data.
Analyzes existing processes and streamline to maximize process efficiency.
In collaboration with the project team, determines clinical and lab data needed to be collected and the appropriate data resources needed, reviews and comments on data collection systems and study specific collection setup.
Provides input to the study team/vendors to improve data integrity and data quality to ensure decision making on good quality data.
Develops Data Management Plan (DMP), maintains DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements.
Develops, reviews and manages Data Transfer Agreement(s) (DTAs) between external data vendors and/or core and plans/organizes secure data transfers in line with project requirements and timelines.
Collaborate with IT and implementation team(s) to address Clinical application requests and/or changes to Clinical database/data repository technical solutions, data transfer solutions.
Demonstrated data management expertise within the field of clinical trials according to applicable standards, guidelines and procedures.
8-10 years of experience
Able to define SOPs and processes for the DM function and activities
Bachelor of Science or equivalent degree is required.
Minimum of 8 years of experience in the data management related to clinical studies.
Complete understanding and application of clinical research procedures.
Working knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related data requirements and terminology.
Working knowledge of Clinical database applications and DM SOPs
Applicable knowledge working with clinical databases, EDC systems, back-end database tools, SAS or other packages.
Strong communication, organizational and interpersonal skills.
Flexibility and ability to adapt and adjust to changing priorities.
Good leadership skills to interface and cooperate with internal and external resources ensuring that company requirements are met.
Demonstrable ability to provide guidance to the study team to ensure that data management goals and objectives are met.
Ability to be supportive of other staff in helping to meet departmental objectives
Good team player; able to work independently under pressure as conditions dictate.
Able to self-motivate and motivate others.
Excellent interpersonal skills are a MUST
This is a temporary project for 32 hours per week, 12/09/2016 till 31/12/2016, longer-term may be discussable. Hourly rate € 68,- including travel costs
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