Clinical Scientist
Spectraforce TechnologiesWaltham, MA, United States5 days ago
Job type
- Full-time
Job descriptionBachelors degree in sciences ; advanced degree (e.g., MS , PhD , PharmD ) preferred 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 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 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
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
Qualification & Experience :
Required Skills :
Experience Level : 3-5 Years
Key Responsibilities :
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Clinical Scientist • Waltham, MA, United States
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