Senior Clinical Research Scientist

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the design, development, and implementation of clinical studies, ensuring accountability for protocols, clinical documents, and the overall quality of studies in accordance with GCP and regulatory standards. This includes, but is not limited to:

• Conducting thorough, ongoing evaluations of clinical trial data (e.g., safety, efficacy, adverse events, laboratory results)

• Detecting data trends, inconsistencies, and possible safety signals; appropriately escalating findings

• Generating, monitoring, and resolving data queries in collaboration with data management and clinical operations

• Ensuring the accuracy, completeness, and consistency of clinical data across various systems and reports

• Engaging in study initiation and oversight activities, including vendor management and collaboration with CROs

• Contributing to site-facing activities such as investigator support, training, and query resolution

• Actively identifying risks and implementing mitigation strategies, especially in areas like enrollment, site performance, and operational execution.

• Participating in the creation, writing, and review of essential clinical and regulatory documents, which include protocols, clinical study reports, informed consent forms, safety updates, and submission materials.

• Supporting the review and interpretation of clinical data, encompassing safety and efficacy data

• Maintaining a comprehensive understanding of program data and emerging clinical insights

• Aiding in publication and data dissemination strategies, which involve the development of abstracts, presentations, and manuscripts.

⛳️ Requirements

• An advanced scientific degree is required (PhD, PharmD, MD, or equivalent).

• A minimum of 2 years of experience in clinical research within biotech or pharmaceutical settings, with a strong preference for candidates with experience in early-stage or build-phase companies.

• Proven ability to work independently and collaboratively in fast-paced, ambiguous environments with limited infrastructure.

• Solid understanding of GCP, clinical trial design, and regulatory requirements, with the capacity to balance scientific rigor, compliance, and practical execution.

• Familiarity with electronic data capture (EDC) systems (e.g., Medidata RAVE or similar); previous experience in data query management and data cleaning activities is preferred.

• Experience in clinical data review, including safety, efficacy, and/or laboratory data, along with knowledge of statistical methodologies.

• Practical experience with data visualization software (e.g., GraphPad Prism).

• Excellent written and verbal communication skills, with the ability to simplify complex scientific information and influence cross-functional stakeholders.

• High attention to detail and strong organizational abilities.

• Experience in autoimmune diseases, immunology, neurology, or hematology is preferred.

• Willingness to travel as necessary to support clinical sites, investigator meetings, and scientific conferences.

🏝️ Benefits

• Bonus

• Benefits

• Equity participation