Senior Clinical Data Manager is a full time senior management position reporting to the Director, Clinical Data Management in the US. Managing all phases of data management activities, acting as the lead for Australia Based Trials and also supporting the Data Management team conducting trails in the US. Initially starting on a contract with the option of becoming an employee should the partnership be successful.
- “Start up” feel – manage your own time/ day
- Flexible work life: balance – Family Feel Team
- Office and Home based
- Exciting Oncology and Infectious Disease Trials across all phases
- Opportunity for Growth
- Attractive Hourly rate
This role is with an excellent and successful US based CRO who are expanding operations in Australia. With an Office in Sydney offering excellent company culture and family feel environment, you will be working with a small team based on the ground including one of the founders however reporting to the VP of Data Management in the US and working closely with US counterparts to continue Data Management duties once the US closes for the day as well as taking the lead on Australian Trials. The company is currently working on Phase I-IV trials mainly across Oncology and Infectious Diseases. “Start up “Feel to the business whilst also having the network and support of colleagues overseas, this is an excellent and rare opportunity for a Data Manager to come in at an early stage and make your mark on the business.
- 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
- Direct team members in daily activities including training and supervising Clinical Data Managers I and II
- 10 years’ Experience as a Data Manager
- Relevant Life Science Degree - B.S. /B.A. in a science or technical discipline degree with 6 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
- 3 years 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 Food and Drug Administration (FDA), Europe Medicines Association (EMA), International Conference on Harmonisation (ICH) guidelines and Good Clinical Practices (GCPs) including regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing
- Ability to work both independently and as part of a global team. You will be working individually in Australia however collaborating closely with US counterparts.
Apply for this job online via the link or send your resume directly to Dean Coleman by emailing dean.coleman @ nesgt.com . Confidential enquiries can be made by calling Scott on 02 9696 8016. Only shortlisted candidates will be contacted and we thank you in advance for your interest.