Senior Clinical Scientist

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

📋 Description

• Act as the Clinical Scientist for one or multiple Phase 2 and/or Phase 3 clinical trials.

• Assist in the design of studies, the development of protocols, and any amendments to protocols.

• Create and review documents related to the study, including protocols, investigator's brochures, informed consent forms, clinical study reports, study manuals, training materials, and safety management plans.

• Ensure scientific oversight throughout the study to maintain compliance with the protocol and the quality of data.

• Collaborate closely with Clinical Operations to facilitate study initiation, participant enrollment, trial execution, and conclusion activities.

• Engage in investigator meetings, site training sessions, and scientific discussions with investigators and key opinion leaders.

• Oversee ongoing data reviews and medical monitoring activities in conjunction with Medical Monitors.

• Detect clinical trends, protocol deviations, safety signals, and issues related to data quality.

• Work together with Data Management and Biostatistics to formulate data review plans, edit check specifications, endpoint derivation, and analysis strategies.

• Take part in database locking, data cleaning, and analytical activities.

• Aid in the interpretation of study results and the formulation of key messages.

• Assist in the preparation of regulatory submissions and interactions with agencies.

⛳️ Requirements

• An advanced degree in life sciences, nursing, pharmacy, public health, or a related field (PharmD, PhD, MS, MPH, or an equivalent qualification).

• At least 5–8 years of experience in clinical research within the biotechnology, pharmaceutical, or CRO sectors.

• Proven experience supporting Phase 2 and/or Phase 3 clinical trials.

• Strong knowledge of clinical trial design, clinical data analysis, and the drug development process.

• Familiarity with ICH-GCP, FDA, EMA, and global regulatory standards.

• Experience in reviewing clinical data and collaborating with biostatistics and data management teams.

• Exceptional project management, communication, and organizational abilities.

• Competence to work independently and manage various priorities in a dynamic environment.

🏝️ Benefits

• Periodic travel for investigator meetings, study team gatherings, conferences, and other business-related activities.