Sr. Clinical Research Scientist

Responsibilities

Support the design, development, and execution of clinical studies, with accountability for protocols, clinical documents, and overall study quality in alignment with GCP and regulatory expectations. Including but not limited to:
• Performing comprehensive, ongoing review of clinical trial data (e.g., safety, efficacy, adverse events, laboratory data)
• Identifying data trends, discrepancies, and potential safety signals; escalating findings appropriately
• Generating, tracking, and resolving data queries in collaboration with data management and clinical operations
• Ensuring accuracy, completeness, and consistency of clinical data across systems and reports
• Participating in study start-up and oversight activities, including vendor management and CRO collaboration
• Contribute to site-facing activities, including investigator support, training, and query resolution
• Proactively identify risks and implement mitigation strategies, particularly in areas such as enrollment, site performance, and operational execution.
• Participate in the development, writing, and review of key clinical and regulatory documents, including protocols, clinical study reports, informed consent forms, safety updates, and submission materials.
• Support clinical data review and interpretation, including safety and efficacy data
• Maintain deep understanding of program data and evolving clinical insights
• Support publication and data dissemination strategies, including development of abstracts, presentations, and manuscripts.

Qualifications

Advanced scientific degree required (PhD, PharmD, MD, or equivalent).
2+ years of experience in clinical research within biotech or pharmaceutical environments, with a strong preference for candidates who have operated in early-stage or build-phase companies.
Demonstrated ability to work independently and collaboratively in ambiguous, fast-moving environments with limited infrastructure
Strong understanding of GCP, clinical trial design, and regulatory requirements, with the ability to balance scientific rigor, compliance, and practical execution.
Experience with electronic data capture (EDC) systems (e.g., Medidata RAVE or similar); prior involvement in data query management and data cleaning activities preferred
Experience with clinical data review, including safety, efficacy, and/or laboratory data, and familiarity with statistical approaches
Hands-on experience with data visualization software (e.g., GraphPad Prism)
Excellent written and verbal communication skills, with the ability to distill complex scientific information and influence cross-functional stakeholders.
High attention to detail and strong organizational skills
Experience in autoimmune disease, immunology, neurology, or hematology is preferred.
Willingness to travel as needed to support clinical sites, investigator meetings, and scientific conferences.