**Job Description** The **Project Manager II** will oversee the entire portfolio of Investigator-Initiated Clinical Trials (IICTs)/Clinical Research Sponsor Collaboration (CRSC) within the organization. This role involves coordinating all aspects of trial management, ensuring compliance with regulatory requirements, and facilitating collaboration among multidisciplinary teams to meet project goals. The Project Manager II will work closely with investigators, research teams, regulatory bodies, and institutional leadership to ensure the success of each study in the portfolio. Project Manager II develops and oversees the operational aspects and scope for employee training. Project Manager II is responsible for developing, implementing, and overseeing comprehensive training programs for new staff within the clinical research teams. This role ensures that new employees are equipped with the knowledge, skills, and resources needed to succeed in their roles while adhering to regulatory requirements and organizational standards. The Training role will collaborate with department leaders, senior staff, and other stakeholders to maintain a consistent and high-quality onboarding experience. **Qualifications** + Bachelors degree or greater preferred, or combination of applicable experience and education; PMP certification preferred + 5+ years experience with Masters degree; 7+ years with Bachelors degree, of prior healthcare industry experience required, preferably in the areas of project management, change management, health care delivery re-design or integration, health policy reform. + Minimum of 5 years of experience in clinical research, including at least 2 years managing investigator-initiated trials preferred. + Proven track record in regulatory compliance, project management, and team leadership. + Progressive managerial and clinical job related experience specific to area of responsibility. + Experience in managing and financial management. + Experience in a supervisory capacity preferred. + Strong knowledge of GCP, FDA regulations, and other applicable clinical research guidelines. + Exceptional project management skills with the ability to manage multiple priorities and deadlines. + Effective written and oral communication skills + Effective interpersonal skills; able to establish good working relationships and collaborate with networks of employees of all levels; able to foster cooperation in others; creative problem-solver. + Proficiency in financial management, including budgeting and resource allocation. + Ability to foster a collaborative, supportive, and high-performance team environment. + Hybrid work environment with occasional travel required. + Flexible schedule to accommodate project deadlines and stakeholder needs. **Responsibilities** **_IICT/CRSC: Primary Duties and Responsibilities 75-80%_** **Portfolio Oversight and Management** + Independently manage project teams and collaborations + Manage the lifecycle of trials, including start-up, execution, monitoring, and close-out phases. + Develop, implement, and maintain systems to track progress, milestones, and deliverables across the portfolio. + Prioritize resources and allocate tasks to ensure timelines and objectives are met. **Regulatory Compliance and Quality Assurance:** + Ensure all trials adhere to Good Clinical Practice (GCP) guidelines, institutional policies, and applicable regulatory requirements (e.g., FDA, IRB, ICH). + Oversee the preparation and submission of regulatory documents, including protocols, amendments, and safety reports. + Conduct regular quality assurance checks to identify and mitigate risks. **Financial and Resource Management:** + Develop and manage budgets, ensuring cost-effective use of resources. + Identify funding opportunities and assist investigators with grant applications and budgeting. + Monitor financial performance and reconcile expenses to ensure adherence to budgets **Communication and Stakeholder Engagement:** + Serve as the primary point of contact between investigators, research teams, sponsors, and institutional leadership. + Facilitate regular meetings with stakeholders to provide updates on project status, address challenges, and ensure alignment with organizational goals. + Promote effective communication and collaboration across all teams. **Team Leadership and Development:** + Supervise and mentor clinical research staff involved, fostering a culture of excellence and accountability. + Provide training and development opportunities to enhance team performance and competency. + Delegate responsibilities appropriately, encouraging team members to excel in their roles. + Resolve conflicts and issues within teams. **Process Improvement:** + Identify opportunities to improve workflows and standard operating procedures (SOPs) related to study management. + Develop and implement best practices to enhance efficiency, data quality, and compliance. + Monitor industry trends and integrate innovative strategies into the program. + Ensure that team meetings have structure and clear purposes and goals; facilitate meetings effectively and clearly communicate decisions and action items to team members and relevant parties outside of the team. **_Staff Training Key Responsibilities 20-25%:_** **Training Program Development and Implementation:** + Design and implement a structured training curriculum tailored to various roles within the clinical research team, including Clinical Research Coordinators (CRCs), nurses, and other support staff. + Regularly update training materials to reflect current regulations, organizational policies, and best practices in clinical research. + Incorporate input from senior leadership, subject matter experts, and team members into training content. **New Staff Onboarding:** + Conduct onboarding sessions to introduce new staff to clinical research processes, organizational expectations, and compliance standards. + Provide hands-on training in key areas such as protocol review, patient interactions, regulatory documentation, and data management. + Ensure new staff understand and follow Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP) guidelines. **Continuous Education and Competency Development:** + Assess the training needs of new staff and create individualized learning plans where needed. + Conduct periodic evaluations to measure staff competency and identify areas for improvement. + Organize workshops, refresher courses, and other opportunities for ongoing professional development. **Collaboration and Communication:** + Work closely with managers and senior staff to identify training gaps and opportunities for improvement. + Serve as a liaison between new hires and leadership, providing feedback and addressing concerns during the onboarding process. + Foster a supportive environment that encourages learning and growth. **Documentation and Compliance:** + Maintain detailed records of training sessions, attendance, and individual progress. + Ensure all training activities are documented in compliance with regulatory and organizational requirements. + Support audits and inspections by providing training documentation as required. **Mentorship and Support:** + Pair new hires with experienced mentors to enhance their learning experience and foster team integration. + Provide guidance and support to ensure a smooth transition into their roles. + Address challenges faced by new hires and offer constructive solutions. **About Us** **Strength Through Diversity** The Mount Sinai Health System believes that diversity, equity, and inclusion are key drivers for excellence. We share a common devotion to delivering exceptional patient care. When you join us, you become a part of Mount Sinai’s unrivaled record of achievement, education, and advancement as we revolutionize medicine together. We invite you to participate actively as a part of the Mount Sinai Health System team by: + Using a lens of equity in all aspects of patient care delivery, education, and research to promote policies and practices to allow opportunities for all to thrive and reach their potential. + Serving as a role model confronting racist, sexist, or other inappropriate actions by speaking up, challenging exclusionary organizational practices, and standing side-by-side in support of colleagues who experience discrimination. + Inspiring and fostering an environment of anti-racist behaviors among and between departments and co-workers. At Mount Sinai, our leaders strive to learn, empower others, and embrace change to further advance equity and improve the well-being of staff, patients, and the organization. We expect our leaders to embrace anti-racism, create a collaborative and respectful environment, and constructively disrupt the status quo to improve the system and enhance care for our patients. We work hard to create an inclusive, welcoming and nurturing work environment where all feel they are valued, belong and are able to advance professionally. Explore more about this opportunity and how you can help us write a new chapter in our history! **“About the Mount Sinai Health System:** Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 43,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time — discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients’ medical and emotional needs at the center of all treatment. The Health System includes approximately 7,400 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics and top 20 in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report’s “Best Children’s Hospitals” ranks Mount Sinai Kravis Children's Hospital among the country’s best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 14 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek’s “The World’s Best Smart Hospitals” ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally. The Mount Sinai Health System is an equal opportunity employer. We comply with applicable Federal civil rights laws and does not discriminate, exclude, or treat people differently on the basis of race, color, national origin, age, religion, disability, sex, sexual orientation, gender identity, or gender expression. We are passionately committed to addressing racism and its effects on our faculty, staff, students, trainees, patients, visitors, and the communities we serve. Our goal is for Mount Sinai to become an anti-racist health care and learning institution that intentionally addresses structural racism.” **EOE Minorities/Women/Disabled/Veterans** **Compensation Statement** Mount Sinai Health System (MSHS) provides a salary range to comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $78000 - $138490.92 Annually. Actual salaries depend on a variety of factors, including experience, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.