Freshers B.Pharm/B.Sc can apply for post of Senior Clinical Data Manager in PAREXEL
PAREXEL International is a growing, fast-paced, global Clinical Research Organization (CRO) that has helped bring to market 49 of the top 50 selling pharmaceuticals. In fact, we have worked with all 10 of the world's top 10 pharmaceutical companies.
Given our breadth of expertise and the trust placed in us by major pharmaceutical companies worldwide, PAREXEL can provide you with a number of career options in Clinical Research that can rarely be found within just one company. In fact, over 25% of the positions opened at PAREXEL are filled by current employees working to advance their skills and careers.
Post: Senior Clinical Data Manager
- Working to ICH GCP and other applicable industry standards;
- Review of protocols as appropriate;
- Review of CRF's as appropriate;
- Management of project timelines (including creation, review and tracking);
- Creation and review of Data Management Plans;
- Creation and/or review of Data Validation Specifications;
- Set-up of all EP Clinical Data Management systems;
- Testing of the setup of all EP Clinical Data Management Systems;
- Programming edit/consistency checks in all EP Clinical Data Management systems;
- Management of data transfer processes from all EP Clinical Data Management systems in SAS or other Clinical Data Management systems;
- Development or review or input to mapping programs;
- Development or review or input to database listings;
- Provision of status reports to the Project Manager or sponsor on a regular basis;
- Oversight of departmental quality;
- Oversight of clinical data file transfer;
- Working on constant improvement of existing Data Management systems;
- Participation of all trainings to ensure the high quality of the Data Management deliverables;
- Leader or/contributor to (cross) departmental processes;
- Adherence to defined/described Data Management processes;
- Act as functional/departmental trainer;
- Supervision of Data Support Specialists as needed;
- Oversee departmental training compliance;
- Mentoring of Data Management staff;
- Contribution to creation of functional forms and templates;
- Contribution of functional SOP creation;
- Implementation/Monitoring of functional SOP compliance;
- Presentation of Data Management (DM) capabilities to potential sponsors;
- Liaising with and advising clients as required;
- Liaising where appropriate with PAREXEL Data Management groups worldwide (Berlin, Bloemfontein, Baltimore, Late Phase Data Management groups);
- Data entry as appropriate;
- Creation of annotated CRF?s;
- Medical coding (including Adverse Events, Concomitant Medications and Medical History).
- Well developed literary, numeric & computer skills;
- Excellent interpersonal & negotiation skills;
- Attention to detail;
- Ability to work well under pressure and to keep to scheduled timelines.
- Degree in a scientific subject or any other related area.
- Excellent written and spoken English.
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 12th June, 2012
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