Position Title:Clinical Scientist II Assignment Duration:6 months (Possible Extension) Work Arrangement:Hybrid (preferred onsite in Boston/Waltham, MA 02451. If not, must be able to commute – Chicago, IL 60064 or South San Francisco, CA 94080.
Position Summary:
Contribute to the review, interpretation, and communication of scientific data pertaining to the efficacy and safety of compounds in development
Ability to provide input and direction to clinical research with appropriate supervision
Strong desire to collaborate in a cross-functional setting
Clinical trial experience in the pharmaceutical industry, academia, or equivalent preferred
Knowledge of clinical trial methodology, regulatory and compliance requirements, and experience in the design of study protocols
Required Skills:
Oncology clinical trial experience in solid tumors in the pharmaceutical industry
Hands-on experience with data review, data cleaning, data analysis, and extensive experience using EDC, CTMS, and other databases
Contribute to the scientific content of Study Protocols, Investigator Brochures, Clinical Study Reports, Informed Consent Forms, briefing documents, charters, and regulatory documents
Excellent written and verbal communication skills, detail-oriented organization skills, and team collaboration skills
Experience Level:3-5 Years
Key Responsibilities:
Attend congresses and review literature to develop and augment expertise in therapeutic area
Help develop program strategies including the clinical development plan, product lifecycle plans, target product profiles, and draft labels
Review competitive landscape and help identify and evaluate business development opportunities
Provide focused scientific and clinical study support from start-up clinical study report (CSR)
Participate in scientific education of internal and external stakeholders on pre-clinical (e.g., mechanism of action, animal models) and clinical (e.g., epidemiology, diagnosis, treatment) data relevant to program
Engage in opinion leader interactions to build pipeline awareness and foster research collaborations
Contribute to the scientific content of Study Protocols, Investigator Brochures, Clinical Study Reports, Informed Consent Forms, briefing documents, charters, and regulatory documents
Contribute to creation of electronic database, IRT, and associated training documents; review data completeness and fidelity throughout study conduct
Collaborate cross-functionally to create a scientific platform in support of regulatory, commercial, and medical education strategy for late-stage assets
Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards in conducting research
Contribute to authorship of regulatory responses and participate in meetings
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 48.00/hr.
