Contract Clinical Scientist

Role Overview

As a Clinical Scientist contracted for onsite duties in Massachusetts, you will actively collaborate with Clinical Development Leads to review clinical protocols, uphold regulatory and Good Clinical Practice (GCP) standards, and oversee safety and efficacy data management. Your role will intersect Clinical Operations, Data Management, and Biometrics teams, focusing on advancing innovative treatments for neuromuscular diseases.

Key Duties

• Enhance medical monitoring oversight ensuring correct delegation and execution for clinical studies.
• Support Clinical Development Leads in executing strategic development plans for novel drug candidates within multi-disciplinary trial teams.
• Collaborate cross-functionally with Clinical Operations, Data Management, and Biometrics to create study tools, data reports, and comprehensive plans.
• Review clinical trial documentation with therapeutic insight and patient selection considerations alongside Clinical Development Leads.
• Monitor trial conduct vigilantly to guarantee compliance with GCP, protocol adherence, and patient eligibility standards.
• Lead the review, cleaning, analysis, interpretation, and communication of medical data for ongoing and finalized studies.
• Oversee safety data evaluation, promptly addressing any safety issues as they arise.
• Assist in preparation and review of regulatory communications including INDs, IBs, annual reports, clinical study reports, abstracts, manuscripts, and presentations.
• Adhere to and help implement quality standards and standard operating procedures throughout clinical development processes.

Qualifications and Skills

• Graduate-level degree (MD, PhD, RN, PA, NP, PharmD) preferred; Bachelor's degree acceptable with industry experience.
• 3 to 5 years of experience in drug development, with essential medical monitoring experience; direct patient care a strong advantage.
• Deep understanding of regulatory requirements and responsive experience to Health Authority inquiries.
• Expertise in medical data review, cleaning, analysis, and interpretation.
• Prior work in genetic therapeutics preferred; additional skills in non-DMD areas such as Immunology advantageous.
• Capability to independently manage critical tasks while involving senior leadership appropriately.
• Strong familiarity with Good Pharmacovigilance Practices (GVP) and FDA/EMA regulations.
• Excellent interpersonal and communication abilities.
• Proficiency with Microsoft Office tools, including PowerPoint and Excel.
• Willingness to travel as required.

Additional Information

Permanent employees at this organization are eligible for various benefits, including health coverage, life insurance, disability insurance, and 401k plans.

The employer is dedicated to diversity and inclusivity and provides equal employment opportunities without discrimination based on legally protected characteristics. Reasonable accommodations for persons with disabilities in the application or interview process are available upon request.