Proclinical is currently recruiting for a Clinical Scientist with a leading biotechnology company located in San Diego, CA. As the Clinical Scientist, you will be responsible for the design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct.
- Collaborate and liaise with external partners (e.g., KOLs).
- Develop protocol and ICF documents / amendments and present these to governance committee and development team meetings as required.
- Conduct literature reviews.
- Submit clinical documents to TMF.
- Develop site and CRA training materials and present these at SIVs and investigator meetings.
- Review clinical narratives.
- Monitor clinical data for specific trends.
- Develop data review plan in collaboration with Data Management.
- Review data listings and tables to support data cleaning efforts.
- With supervision from the Medical Lead, participate in medical monitoring meetings with the CROs.
- Review protocol deviation classifications and coding.
- Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
- Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.).
- Participate in vendor selection.
- Review site feasibility.
- Review key study documents.
- Develop DSMB/DMC study charters, prepare for and lead meetings for key study committees.
- Provide clinical /scientific advice to the study team and participating clinical sites.
- Review SAP and TLGs.
- Lead and develop clinical portion of advisory boards.
- Author and/or review abstracts, publications.
- Perform other duties as necessary.
Skills and Requirements:
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred). 5 years of pharmaceutical or biotech industry experience preferred.
- Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
- Ability to understand assigned protocol(s) and their requirements.
- Basic knowledge skills to support program-specific data review and trend identification.
- Intermediate medical writing skills and medical terminology.
- Basic planning/project management skills (develop short range plans that are realistic and effective).
If you are having difficulty in applying or if you have any questions, please contact Nicole Aganon at (+1) 347-293-1161 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.