Note: The job is a remote job and is open to candidates in USA. Premier Research is seeking a Clinical Business Operations Analyst II - Systems and Data to support site identification activities within its Clinical Monitoring, Site Management and SSU team. The role manages site outreach, tracking and reporting, maintains investigator data, and supports systems and reporting related to clinical studies.
Responsibilities
- Proactively builds and maintains internal and external relationships to support the gathering of business intelligence to support financial & specific operational activities
- Oversees site outreach for post award Site ID activities
- Progresses and tracks in the CTMS site identification activities according to study timelines; manages time and project requirements based on study contract and works with internal and external customers/vendors to meet project specific goals
- Provides weekly project progress reports to Internal and External project teams including department management; may provide information from the Investigator Database regarding timelines, site contact information, PI specialty, etc. Updates Investigator Database with new sites and investigators, reviewing entries for duplicates, and any information obtained during the site selection process as well as after studies have completed
- Oversees the distribution, tracking and review of SRQs for completeness, site capability and availability based on project specific requirements and needs; identifies, monitors, documents, and tracks out-of-scope activities
- Assists in the design and implementation of all relevant systems including, but not limited to, the site identification metrics and reporting, surveys, etc
Skills
- Undergraduate degree or its international equivalent preferably in the Sciences or in a related field from an accredited institution
- Three years of data management, clinical operations, or start-up experience in the Pharmaceutical, Biotech, and Medical Device industry
- Two years' experience in supporting CTMS
- Strong analytical and problem-solving skills
- Good working knowledge of Clinical database applications such as EDC and CTMS
- Experience in clinical trials support, site partnership management, site identification/selection or pharmaceutical industry
Benefits
- Remote work
- Health insurance, retirement plans, and paid time off may be included in the comprehensive benefits package.
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