Senior Project Manager, Clinical Research
|Job Title:||Senior Project Manager, Clinical Research|
|Contact Name:||Amy Ma|
|Job Published:||February 28, 2017 17:15|
- Develop clinical protocols and/or investigational plans, informed consent forms, case report forms, handouts, SOPs, analyses, etc. as needed. Prepare status reports, as required.
- Liaison between company, investigational sites, and CROs (as applicable) to coordinate and document clinical research studies. Respond to written and telephone inquires from investigational sites, as applicable.
- Collect, query, analyze, and present clinical data. Develop and maintain any applicable clinical research databases as necessary.
- Identify required biocompatibility testing, work with legal to develop a contract and ensure timely completion and accuracy of final report.
- Conduct basic statistical analyses for technical support of product line.
- Conduct literature reviews and write research summaries related to product line.
- Interface with technical representatives, regional managers, and research teams for the purpose of technical training and addressing customer questions/concerns.
- Prepare product Instructions for Use and assist with labeling and labeling changes (including receipt of applicable translations).
- Generate final clinical study reports.
- Communicate with customers and field staff regarding the planning of clinical trials, complaints, problems, and general correspondence.
- Evaluate and report on adverse events, complaints, and failures associated with the product line.
- Attend surgical congresses as necessary.
- Complete necessary product Clinical Evaluation Reports and/or any other reports necessary to support regulatory submissions.
- Coordinate the execution of peer-reviewed projects (publications, posters, abstracts) marketing literature.
- Responsible for site recruitment/selection, investigator meetings, and management of clinical study sites.
- Ensure that clinical trials are conducted in accordance with applicable standards and regulations.
- Oversee project budgets, budget change forms, accruals, and monthly reports.
- Other assigned responsibilities (including previously identified tasks being performed at a higher level than one's current title)
- Minimum 4-6 years experience, within the medical/biomedical industry.
- Experience managing a clinical project team and Phase III clinical studies.
- BS or MS degree in biological science, epidemiology, engineering, statistics, or other science-related field.
- CRA certification or certification eligContinueible.
- Demonstrated statistical and computer skills (spreadsheet, relational databases, intermediate to advanced statistical analysis).
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