Clinical Scientist – Consultant

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

📋 Description

• Analyze clinical data to create comprehensive summaries and insights that support regulatory submissions, publications, and scientific communications.

• Work collaboratively across various functions, including Medical Directors, Clinical Operations, Data Management, Biostatistics, and Business Operations throughout clinical trial phases.

• Take the lead or assist in drafting specific sections of clinical study reports in collaboration with Medical Directors.

• Facilitate real-time data evaluations, identify trends in safety and efficacy, assess adherence to protocols, and review any protocol deviations.

• Raise pertinent issues to Medical Monitors as necessary.

• Spot scientific and clinical quality concerns for discussion with principal investigators and study sites.

• Collaborate with study teams and members of the GCP quality team regarding escalations.

• Provide consultation on the design of study-specific case report forms and author sections of CRF completion guidelines.

• Ensure that CRFs meet study requirements during user acceptance testing procedures.

• Conduct safety and efficacy reviews in preparation for Data Monitoring Committee meetings.

• Evaluate trends within and across various clinical programs.

• Partner with Business Operations and Data Management to enhance clinical data technology access, retention, and visualization strategies.

• Assist in the integration of new tools and technologies into phase 1-3 clinical trials.

⛳️ Requirements

• A Ph.D., PharmD, MD, Nursing, or Clinical Master’s degree in a relevant scientific discipline.

• Over 6 years of experience in clinical development within the biotechnology or pharmaceutical sector.

• Solid understanding of clinical development processes for phase 1-3 clinical studies.

• Prior experience in identifying trends and establishing risk mitigation strategies alongside Medical teams during clinical studies.

• Proven experience in designing and executing clinical trials.

• Strong knowledge of GCP/ICH guidelines and regulatory requirements.

• Experience in rare diseases and/or neuromuscular diseases is highly preferred.

• Proficient in Microsoft Office Suite and advanced data review tools, including patient profiles and report generation tools.

• Self-driven, with a proven track record of successfully meeting deadlines on assigned tasks.

• Demonstrated ability in creative problem-solving and a strong aptitude for learning.

• Capability to interpret complex data and communicate effectively with both scientific and non-scientific stakeholders.

• Excellent data analysis, data visualization, and communication skills.

• Proficient in writing clear, accurate, and concise documents, creating informative figures, and presenting to varied audiences.

• Eagerness to work in an innovative, collaborative, fast-paced, mission-oriented environment.

• Must be eligible to work in the US or meet location requirements.

🏝️ Benefits

• Flexible working environment.

• Remote work options available.

• Contract role with an expectation of 40 hours per week.

• Minimal quarterly travel to Entrada Therapeutics Headquarters located in Boston, MA.