Clinical Outcome Assessments Expert

3 days ago

Singapore IQVIA Full time

**Job Overview**
- Responsibility and oversight for Clinical Outcome Assessments (COA) including all associated processes (for example, rater training and qualification, monitoring of rater performance and COA data quality, interpretation of COA data), ensuring delivery of quality data
- Vendor oversight of COA vendors from initiation through to study close-out, including review of contracts and budget negotiations (if vendor is contracted directly), on-boarding procedures, ongoing study performance (development of KPIs)
- Reviews and co-ordinates internal approval where required, of third-party vendor documents relating to COA, e.g. Rater Qualification Program, Data Monitoring Methodology, Rater Guidelines, Investigator Meeting material
- Oversees the collaboration between the COA vendor with the CRO and other vendors
- Subject matter expert for COA and integrates data from internal, external, academic, and conference sources in support of this

**Qualifications**
- Bachelor's Degree Bachelor's degree in relevant scientific discipline (Some CAP/CLIA lab locations may require a BS in chemistry, biology, or medical laboratory technology degree) Req
- 1 year of related experience in Psychiatry & **Neurology**:

- Proficiency with Rater training
- General awareness of the broader drug development process and the interaction of method development in that process.
- Ability to troubleshoot laboratory equipment and resolve process issues.
- Basic understanding of requirements under relevant regulatory standards for assigned work area.
- Good computer skills including proficiency with Microsoft Excel, PowerPoint and Word.
- Capable of handling multiple tasks simultaneously.
- Strong attention to detail and accuracy.
- Effective organizational and interpersonal skills.
- Effective communication and presentation skills.
- Ability to work closely with other members of the laboratory.
- Ability to maintain a minor degree of independence to complete assigned tasks and projects.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.

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