Key Responsibilities & Essential Functions
• Develop and finalize study protocols, including experimental design, methodology, and timelines, in collaboration with cross-functional teams and clients.
• Lead and oversee all aspects of assigned studies, including resource allocation, budget management, and timeline adherence, to ensure timely and efficient execution.
• Provide scientific guidance and expertise throughout the study lifecycle, including protocol development, data analysis, and interpretation of results.
• Ensure studies are conducted in accordance with relevant regulatory requirements.
• Implement quality control measures to maintain the integrity, accuracy, and reliability of study data, including oversight of documentation and record-keeping practices.
• Lead and mentor multidisciplinary project teams, including scientists, technicians, and support staff, to foster a collaborative and high-performing work environment.
• Oversee data analysis activities, ensure robust statistical analysis methodologies are applied, and prepare comprehensive study reports for internal review and client submission.
• Identify and mitigate potential risks and challenges that may impact study timelines, data quality, or compliance with regulatory requirements.
• Other duties as assigned.

Knowledge, Skills, and Abilities
• Extensive experience in scientific research, preferably in a pharmaceutical, biotechnology, or contract research organization (CRO) environment, with a track record of successful study management.
• Proven leadership and project management skills, with the ability to effectively plan, organize, and coordinate complex research projects from initiation to completion.
• Proficiency in data analysis and interpretation, including statistical analysis methodologies and software tools (e.g., SAS, R, SPSS).
• Excellent verbal and written communication skills, with the ability to convey complex scientific concepts clearly and effectively to diverse audiences
• Strong leadership and interpersonal skills, with the ability to inspire and motivate multidisciplinary teams to achieve project objectives and deliver high-quality results.
• Strategic thinking and problem-solving abilities, with a proactive approach to identifying and resolving challenges that may arise during study execution.
• Thorough understanding of regulatory requirements governing preclinical and clinical research studies, including GLP, ICH guidelines, and other relevant regulations.
• Strong problem-solving skills with the ability to identify issues and implement effective solutions in a timely manner.
• Flexibility and adaptability to changing priorities and deadlines in a fast-paced, dynamic work environment

Experience Required/Preferred: 7 years/ 10 years

Education Required/Preferred: Master's/ Doctorate

Pay Range: $85,987 - $133,678, salary is determined by years of experience