Clinical Scientist

Summary: The Clinical Scientist role is a full-time, remote position within the EU, focused on the design, implementation, and management of clinical trials for a leading biotechnology company. The successful candidate will collaborate with cross-functional teams to ensure compliance with regulatory requirements and the integrity of clinical data. This position requires extensive experience in clinical research and a strong understanding of trial design and methodology. The role is critical in supporting drug development programs aimed at improving patient outcomes.

Key Responsibilities:

• Design and develop clinical study protocols in collaboration with clinical, regulatory, and medical teams.
• Ensure protocols are scientifically sound, aligned with regulatory requirements, and meet the strategic objectives of the project.
• Oversee the execution of clinical trials, ensuring compliance with Good Clinical Practice (GCP) guidelines and regulatory requirements.
• Monitor study progress, manage timelines, and ensure the quality and integrity of data.
• Collaborate with biostatisticians and data management teams to analyze clinical trial data.
• Interpret data and prepare clinical study reports, manuscripts, and presentations for internal and external stakeholders.
• Prepare and review regulatory documents for clinical trial applications and submissions.
• Liaise with regulatory authorities as needed to facilitate approvals and address queries.
• Work closely with cross-functional teams, including medical affairs, regulatory affairs, pharmacovigilance, and project management.
• Communicate study progress, findings, and issues to internal and external stakeholders.

Key Skills:

• Advanced degree (PhD, MD, or equivalent) in a relevant scientific discipline.
• Minimum of 10 years of experience in clinical research, preferably within the biotechnology or pharmaceutical industry.
• Strong understanding of clinical trial design, methodology, and regulatory requirements.
• Experience in managing clinical trials across different phases (Phase I-IV).
• Proficient in data analysis and interpretation, with a solid understanding of biostatistics.
• Excellent written and verbal communication skills in English; proficiency in other EU languages is a plus.
• Ability to work independently and remotely, with strong organizational and time management skills.
• Proficient in Microsoft Office and clinical trial management systems (CTMS).

Salary (Rate): undetermined

City: London

Country: United Kingdom

Working Arrangements: remote

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other