Sima Reuven

Extensive experience across roles as a CRA, Project Manager, Business Developer, and Study Start-Up Specialist confers a unique skill set, combining operational excellence, strategic vision, regulatory expertise, and versatile communication skills. This multifaceted background positions me to drive efficiency, foster innovation, navigate challenges, and contribute significantly to the success of pharmaceutical endeavors. Gained several advantages due to diverse roles I have played within the pharmaceutical industry: Versatility and Comprehensive Understanding of the drug development lifecycle, from initial research to clinical trials, regulatory compliance, and business aspects. Operational Efficiency and Strategic Planning as a CRA, Project Manager, and Start-Up Specialist fosters efficient project planning, execution, risk assessment, and timeline management in clinical trials. Regulatory Compliance and Quality Assurance - experience across roles contributed to a deeper understanding of regulatory standards, ensuring compliance throughout the drug development process. Comprehensive oversight of trial operations, from start-up to execution, allowed improvement of quality control and risk management strategies. Leadership and Problem-Solving - experience across roles cultivated strong leadership qualities, decision-making skills, and the ability to guide teams through complex projects. Versatility to handle challenges efficiently, using a diverse skill set to address issues from multiple perspectives. Regulatory Specialist - Ensuring that all aspects of clinical trials comply with regulatory requirements set forth by relevant authorities like Local Ethical Committees in Israel (the Helsinki committees), Ministry of Health, FDA and EMA. Documentation and Submissions: Overseeing the preparation, compilation, development of essential documents such as Informed Consent Form, Study Protocol, Monitoring Plan, Patients’ facing documents and more, and submission of regulatory documents required for clinical trials. Top of Form Direct involvement with submitting a CTA to the European Union (EU) via CTD format (electronic submission platform). Direct involvement with submitting a pack for approval by the U.S. FDA via FDA ESG (electronic submission platform) for NDA, and IND. Business Developer in a CRO – Played pivotal role in driving the growth and success of the organization by fostering relationships with clients and seeking new business opportunities. Identified potential clients within the pharmaceutical, biotech, or healthcare sectors aligned with the CRO's services and capabilities. Created compelling proposals and presentations tailored to client needs, showcasing the CRO's expertise, services, and value proposition. Engaged in negotiations, defined contract terms, and finalized agreements to secure partnerships or projects. Conducted market analysis to identify industry trends, competitor analysis, and potential areas for business growth or diversification. Formulated business development strategies aligned with the CRO's goals, identified target markets, and devised plans to penetrate or expand in those markets. Creative Operations Specialist skillful in executing effective operating rhythms and management systems structures. Expertise in analyzing, articulating and solving various problems. Analytical and organized professional comfortable working independently or as part of team. Talented at developing strategies, setting goals and training employees. Confident and decisive when communicating goals and vision to succeed. First-class problem solver with excellent interpersonal skills. Proven track record of successfully managing multiple freelance assignments concurrently, meeting deadlines and client satisfaction. Possessing excellent communication skills while interacting effectively with both technical and non-technical personnel at all levels. Experienced Study start-up and regulatory specialist successfully delivering services on contract or project basis to clients in various industries and specialties. Demonstrated ability to provide expert advice and guidance, helping clients improve market position. Enthusiastic about providing professional support in different environments. Forward-thinking Operations Specialist bringing 23 years of expertise in clinical trials for pharmaceutical sector businesses. Cultivates rapport with individuals to optimize project goals and output, resolve complex problems and deliver innovative improvement strategies. Proficient in state of the art software. Team Leader experienced in directing activities in clinical trials setting. Talented at developing strategies, setting goals and training employees. Confident and decisive when communicating goals and vision to succeed. First-class problem solver with excellent interpersonal skills. Team Leader experienced in directing activities in clinical trials setting. Talented at developing strategies, setting goals and training employees. Confident and decisive when communicating goals and vision to succeed. First-class problem solver with excellent interpersonal skills. Goal-driven regulatory affairs dedicated to providing high-quality construction services to discerning clients. Offering first-rate construction management and field supervision expertise. Skillful in working with architects, inspectors, designers and subcontractors to accomplish high-quality project work. Team Leader experienced in directing activities in clinical trials setting. Talented at developing strategies, setting goals and training employees. Confident and decisive when communicating goals and vision to succeed. First-class problem solver with excellent interpersonal skills. Talented at developing strategies, setting goals and training employees. Confident and decisive when communicating goals and vision to succeed. First-class problem solver with excellent interpersonal skills. Talented at developing strategies, setting goals and training employees. Confident and decisive when communicating goals and vision to succeed. First-class problem solver with excellent interpersonal skills. Team Leader experienced in directing activities in regulatory affairs setting. Talented at developing strategies, setting goals and training employees. Confident and decisive when communicating goals and vision to succeed. First-class problem solver with excellent interpersonal skills. Offering first-rate construction management and field supervision expertise. Skillful in working with architects, inspectors, designers and subcontractors to accomplish high-quality project work. Offering first-rate construction management and field supervision expertise. Skillful in working with architects, inspectors, designers and subcontractors to accomplish high-quality project work. Talented at developing strategies, setting goals and training employees. Confident and decisive when communicating goals and vision to succeed. First-class problem solver with excellent interpersonal skills.