Katalyst CRO ยท 3 months ago
Clinical Scientist II
Boston, MA
Contract
Onsite
Mid Level
3+ years expKatalyst CRO is a clinical research organization, and they are seeking a Clinical Scientist II to contribute to the review and communication of scientific data related to drug efficacy and safety. The role involves developing clinical strategies, supporting studies, and ensuring compliance with regulatory standards.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Contribute to the review, interpretation and communication of scientific data pertaining to the efficacy and safety of compounds in development
Attends congress and reviews literature to develop and augment expertise in therapeutic area
Help develop program strategy including the clinical development plan, product lifecycle plans, target product profiles and draft labels. Reviews competitive landscape and help identify and evaluate business development opportunities
Responsible for providing focused scientific and clinical study support from start-up clinical study report (CSR)
Participate in scientific education of internal and external stakeholders on the pre-clinical (e.g. mechanism of action, animal models) and clinical (e.g. epidemiology, diagnosis, treatment) data relevant to program. Engage 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 and review data completeness and fidelity throughout study conduct
Collaborate cross-functionally to help create a scientific platform in support of the regulatory, commercial and medical education strategy for late-stage assets
Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Contributes to authorship of regulatory responses and may participate in meetings
Qualification
Required
Bachelor's degree in the 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
Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols
Oncology clinical trial experience in the Oncology (preferably solid tumour's) therapeutic area in the pharmaceutical industry
Hands on experience with data review and clean, data analysis with extensive experience using EDC, CTMS and another database
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
Preferred
Advanced degree (e.g., MS, PhD, PharmD)
Clinical trial experience in the pharmaceutical industry, academia, or equivalent
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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