Clinical Data Manager is a full time position reporting to the Director, Clinical Data Management.
This role is working with a full service CRO that cover multiple therapy areas across Phases I – IV in Melbourne.
- Manage all phases of data management activities and support to internal project teams, clients and Clinical Research Organization (CRO) including the following:
- Review and approve study startup documents, Data Management Plan (DMP), Reconciliation Plan, Quality Control Plan, Coding Plan, Validation Plan, Communication Plan and other documentation as required.
- Supervise data cleaning activities including processing Data Clarification Form (DCF)/query tracking and conducting and orchestrate scheduled cross-functional data review/reconciliation, identification of issues and track through resolution Design and/or approve final Electronic Case Report Form (eCRF)/Case Report Form (CRF), edit check specifications, case report form guidelines and electronic data handling conventions
- Manage database build activities, database validation and review and execution of User Acceptance Testing of clinical databases
- Facilitate internal study team, client and CRO meetings
- Actively review and provide feedback on study data quality including providing data management metrics, review project statement of work and identify and report to manager any requested out of scope activities
- Assist manager in monitoring timelines and managing resources to meet timelines
- Identify inconsistencies and inefficiencies in data management processes and recommend solutions
Qualifications and Abilities:
- 7 years data management experience, or B.S. /B.A. in a science or technical discipline degree with 5 years data management experience, or MS degree with 4 years data management experience; minimum 4 years in the Pharmaceutical/Biotechnology industry or CRO environment
- Meet the requirements of a Clinical Data Manager II with a high degree of proficiency and autonomy
- Some experience supervising Clinical Data Managers and team activities
- Ability to program in SQL or SAS desirable, but not required
- Experience with various data collection and Electronic Data Capture (EDC) systems and related tools and processes
- Excellent oral and written communication skills
- Ability to work in a collaborative and multi-disciplinary environment
- Attention to detail, ability to prioritize and manage multiple projects with competing and aggressive timelines
- Good knowledge of GCP ), Europe Medicines Association (EMA), International Conference on Harmonisation (ICH) guidelines and FDA including regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.
If you are interested in this role please send a resume to dean.coleman @ nesgt.com or call for a discussion on 02 9696 8016