Director Clinical Research

The Director Clinical Research is a vital role responsible for strategic oversight of registries, sub-studies, as well as IDE and post approval clinical studies. This individual will lead a multidisciplinary team to ensure compliance with regulatory requirements, align with corporate objectives, and maintain the highest standards of quality and ethical practices. The role involves collaboration with cross-functional teams, regulatory bodies, and external partners. The Director may serve as the point of escalation for clinical team members/clients and follow-up to ensure that studies are progressing according to plan, provide guidance for risk mitigation as well ensure Leadership is kept informed of study timelines, accomplishments, risks, and plans of action. QUALIFICATIONS: Bachelor’s degree in healthcare, life sciences, or related field. A master’s degree or relevant certification is preferred. However, a combination of experience and/or education will be taken into consideration. 10+ years of experience in clinical project management within a Contract Research Organization (CRO), biotech, or pharmaceutical company. Proven track record of successfully managing clinical trials, including IDE, PMA, and/or 510(k) studies. Strong project management skills, with the ability to manage multiple projects simultaneously. Strong problem-solving skills and the ability to adapt to changing circumstances. Excellent written and verbal communication skills, including the ability to present complex data to diverse audiences. Experience managing direct reports/supporting career growth and development Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems. Strategic thinker with a strong focus on execution and problem-solving. Ability to build relationships with internal and external stakeholders, including KOLs and regulatory authorities. High attention to detail and commitment to ethical research practices. KEY RESPONSIBILITIES: End to Project Oversight: Support study design and budget planning for the initiation of new studies as well as provide ongoing supervision of ongoing clinical research studies to successful completion. This includes budget orecasting, resource allocation, timeline management, and closeout oversight. Ensure that clinical trials are conducted in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and applicable regulatory requirements. Collaborate with clinical vendors; serve as a point of escalation for clinical sites. Drive collaboration with the internal and external stakeholders on deliverables to ensure expected timelines, quality standards, Good Clinical Practices (GCP) and applicable regulations are being met. Direct oversight of cross-functional Study Operations teams Recruit, manage, mentor, and retain a team of clinical research professionals. Provide ongoing performance evaluations, career development opportunities, and training for direct reports. Foster a culture of collaboration, innovation, and accountability within the clinical research team. Delegate responsibilities effectively to ensure efficient and timely execution of clinical projects. Proactively identify project risks and implement risk mitigation strategies. Collaborate with internal teams and external vendors to ensure that project goals are met. Prepare and present status updates to executive management and stakeholders. Performs other duties as assigned. LOCATION AND TRAVEL REQUIREMENTS: This is a fully remote position and may be performed anywhere within the United States of America. Occasional domestic and international travel may be required for company meetings, conferences, audits, etc. This Company participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S." . #J-18808-Ljbffr