Clinical Data Manager
Providing guidance and support within the Clinical Data Team this role provides an essential link between our team and our clients.
Summary about this job
Clinical/Medical Research
Company: CPR Pharma Services Pty Ltd
Location: Adelaide
Work type: Full Time
Salary: n\a
Phone: +61-7-3078-9223
Fax: +61-3-8488-3641
E-mail: n\a
Site: n\a
Detail information about job Clinical Data Manager. Terms and conditions vacancy
CPR Pharma Services (CPR) full-service CRO with an international reputation for delivering high quality clinical trial results. We combine clinical and data management services with a bio-analytical capability. We facilitate quality drug development by aligning our people, their skills and expertise in the pursuit of a healthier world.
Opportunity
An opportunity has arisen for a highly motivated, adaptable and experienced Clinical Data Manager to join the team at CPR. Reporting to the Data Team Manager, this is a full-time permanent position.
We offer training opportunities, flexibility and work-life balance, opportunities for growth and development and all within a fun and stable culture.
Responsibilities include:
- Preparation of Data Management Plans
- Preparation of Edit Check Document
- Development and review of Case Report Forms in line with the database and protocol
- Preparation of clean and erroneous dummy data
- Database Validation
- Preparation and review of Annotated CRF
- Perform data review and cleaning of data collected during the trial
- Preparation of Data Clarification Forms (DCFs) and query resolutions,
- Raising queries in the database while conducting cleaning activities
- MedDRA / WHO-DD Coding
- Assisting in performing QC on study data prior to lock
- Act as Data Project Manager including interaction with CPM, interact with site/ client/ external vendors, perform overall Project Management and timeline management
- Training of Data Associates in CPR processes and Data Management tasks
What you will need to be successful in this role:
- Ordinary degree in the appropriate discipline or equivalent experience
- 2-3 years experience in the pharmaceutical industry / CRO working in a GCP environment
- Solid data entry experience
- Knowledge of ICH GCP Guidelines, medical terminology and clinical trials process
- Experience in EDC/e-CRF systems (highly regarded)
- Excellent planning, time management and organisational skills
- Demonstrated ability to prioritise work and handle deadline pressure
- Ability to set priorities, analyse problems, formulate clear and effective solutions and coordinate a number of tasks simultaneously
- Demonstrated ability to communicate effectively with clients, senior management and other departments
- Intermediate to advanced skills in MS Office suite.
To apply
- Please click on the 'apply for this job' link and submit your CV along with a cover letter outlining your skills and experience that make you suitable for this role, please submit as one Microsoft Word document.
- To be considered for this role you must be able to provide evidence of entitlements to work in Australia.
- As we receive a high volume of applications for our vacancies, we will only contact you directly, should you be successful through to the next stage of our recruitment process.
- For further information about CPR Pharma Services, please visit our website at http://www.cprservices.com.au
CPR Pharma Services is an equal opportunity employer