Clinical Data Manager III
ProClinical is advertising a vacancy for a Clinical Data Manager III position with a leading pharmaceutical research company. The organization prides itself on its solid commercial portfolio of life-saving drugs within a number of therapy areas, along with a growing pipeline of investigational drugs and an unmatched patient access program. Based in the company's California office, this is an exciting opportunity to work with an internationally renowned company and support their innovative impact on the healthcare field.
- Work collaboratively with global, cross-functional study management teams to support post marketing studies primarily in Korea and may also support studies in other regions
- Provide vendor oversight, communicating expectations for study timelines and data quality
- Provide CDM input during CRO selection process in order to select appropriate CRO by reviewing RFP (request for proposal to CRO) and CRO contract, or by attending CRO selection meeting
- Review study protocols
- Ensure completeness, accuracy and consistency of clinical data and data structure through the creation and review of:
- Case Report Forms (CRF) and completion guidelines
- Electronic Data Capture (EDC) requirements and specifications
- Clinical Data Management Plans
- Data Validation Plans
- Data Quality Review Plans
- Provide appropriate guidance to CRO DM personnel to resolve data/query related issues raised by CRO during day-to-day CRF data cleaning
Skills and Requirements:
- 3-5 years' experience and a BS degree.
- Experience working on global cross-functional teams.
- Excellent verbal and written communication skills.
- Experience working with EDC systems.
- Understanding of Good Clinical Practice.
- Vendor management experience.
- Experience with post marketing studies.
- Experience with Korean Post Marketing Surveillance studies.
- Understands Korean regulations.
- Korean written and verbal skills.
- Experience with DreamCIS EDC system.
- Experience in anti-viral therapeutic areas (HIV, HCV, HBV).
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Sherron Howard at +267 435 8600 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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