Clinical Research Manager

Job Title: Program Director – Early Phase Clinical ResearchJob DescriptionThe Program Director leads the operational and financial aspects of an early phase clinical research program at an NCI-designated cancer center, with a primary focus on training and onboarding new study coordinators, managing a complex clinical trials portfolio, and ensuring compliance with regulatory and billing requirements. This role works closely with a multidisciplinary research team to support patients enrolled on early phase therapeutic trials and serves as a key liaison with external sponsors and regulatory bodies.ResponsibilitiesTrain and onboard new study coordinators, ensuring they understand clinical trial protocols, regulatory requirements, and internal processes.Work closely with program leaders, co-investigators, research coordinators, research nurses, data managers, and protocol office staff to manage each patient accrued to early phase studies.Oversee billing compliance for early phase therapeutics trials, ensuring proper ordering and association of consults and ancillary services such as laboratory tests and imaging.Review charges and designations after each visit is closed to ensure accurate and compliant billing practices.Manage the clinical trials portfolio for early phase studies and drive timely start-up of protocols to meet NCI expectations of less than 90 days from activation requirements.Review Medicare coverage analyses to confirm appropriate procedure-level designations and alignment with protocol and payer requirements.Serve as the principal liaison for the early phase clinical research program with pharmaceutical and biotechnology companies, fostering collaborative sponsor relationships.Prepare for and support NIH, BRANY, sponsor audits, and FDA inspections, ensuring documentation and processes meet regulatory standards.Participate in departmental and institutional committees as needed, contributing operational and clinical research expertise.Provide leadership, guidance, and oversight to the clinical research team, including CTMS staff, clinical research coordinators/data coordinators, nurse practitioners, and physician assistants.Perform other duties as assigned to support the success and growth of the early phase clinical research program.Essential SkillsMinimum of 5 years of related work experience in clinical research or clinical operations.Prior clinical research experience in early phase drug development.Strong knowledge of federal and local regulations governing clinical research.Demonstrated experience in clinical operations, including management of clinical trials and study coordination.Proven ability to onboard and train new staff effectively.Ability to interpret and apply Medicare coverage analyses and procedure-level designations.Experience with billing compliance processes in a clinical research setting.Excellent communication and collaboration skills for working with multidisciplinary research teams and external sponsors.Strong organizational and time management skills to manage multiple protocols and meet start-up timelines.Additional Skills & QualificationsDegree in Life Science or Public Health required.ACRP or SOCRA certification obtained within 24 months of employment.MD or DO (or foreign equivalent) degree preferred.Familiarity with CITI training requirements for human subjects research.Knowledge of IATA requirements related to clinical research activities.Experience working in an NCI-designated cancer center or oncology research environment is highly desirable.Ability to represent the clinical research program professionally in interactions with pharmaceutical and biotechnology partners.Capacity to contribute to departmental and institutional committees and initiatives.Job Type & LocationThis is a Contract position based out of Bronx, NY.Pay And BenefitsThe pay range for this position is $65.00 - $65.00/hr.RequirementsEligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)Workplace TypeThis is a hybrid position in Bronx,NY.Application DeadlineThis position is anticipated to close on May 13, 2026.Diversity, Equity & InclusionAt Actalent, Diversity And Inclusion Are a Bridge Towards The Equity And Success Of Our People. DE&I Is Embedded Into Our Culture ThroughHiring diverse talentMaintaining an inclusive environment through persistent self-reflectionBuilding a culture of care, engagement, and recognition with clear outcomesEnsuring growth opportunities for our peopleActalent is an equal opportunity employer.About ActalentActalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.