Clinical Research Program Manager - Multi Site Operations
Behavioral Health Market Context
Apply Nowvia Medical Hirings - Talent Rush HQ
Qualifications
- •We’re looking for a Clinical Research Program Manager who brings strong experience in clinical trial operations—someone who understands what it takes to move a study forward from start-up through closeout
- •To set you up for success, we’re looking for at least five years of clinical trial management experience, including three years leading multi-site studies
- •In this role, you’ll partner closely with CROs, vendors, and cross-functional teams, building strong relationships that help drive studies forward with clarity and efficiency
- •We are seeking a candidate with at least five years of experience in management, program, or project management, ideally within a clinical research setting
- •In this role, you will lead and support multi-site clinical trial start-up and management, working closely with cross-functional stakeholders to drive studies forward efficiently and compliantly
- •Experience with both industry-sponsored and investigator-initiated trials is highly valued, as you will contribute across a diverse portfolio of studies
- •This is an opportunity for a detail-oriented, proactive professional who thrives in a collaborative, hands-on environment and is ready to take ownership of complex clinical trial operations
- •High School Diploma or GED
- •5 years of experience in Management, Program Management, Project Management, or a related field
- •3 years of related experience in a clinical research or industry setting
- •7 more items(s)
Responsibilities
- •You’ll be stepping into a collaborative, supportive team environment where your expertise in multi-site trial management, protocol and database development, and overall study lifecycle execution will be valued and relied on
- •Responsible for directing and managing Cedars-Sinai's multi-site clinical coordinating center
- •Provides leadership, guidance and direction for the day-to-day clinical research operations and activities, including authority to make independent decisions regarding program operations, administration, and governance
- •Ensures compliant, efficient, and effective conduct of the clinical trials within the portfolio
- •Establishes, implements, and evolves operational standards and monitors quality and progress of the clinical coordinating center
- •Oversees and/or manages a multi-site clinical coordinating center with a robust portfolio of trials
- •Responsible for program development and expansion
- •Plans and implements program operations, determines and develops governance, processes and/or guidelines, coordinates program activities and timelines, and determines and organizes resources to meet program objectives
- •Identifies and defines any logistics, action items, changes, or information needed to effectively manage the program
- •Identifies barriers to timely study activation, efficient coordination, and participate to identify/implement potential solutions
- •May identify program participants and lead cross-functional teams in the administration, maintenance or expansion of the program
- •Interfaces with internal and external key stakeholders including other departments, leaders across the organization, representatives from external agencies/organizations in the management of the program to provide guidance, resolve issues, grow the program, and/or implement processes and/or solutions
- •Identifies growth opportunities and further efficiencies that impact the program and/or departments success and aids in development of strategic plans to achieve objectives
- •Manages study intake process, evaluates feasibility, and providing recommendations or making decisions to support the success of the clinical research program
- •Interfaces with internal/external stakeholders to maintain and further develop program growth, community outreach activities, as well as relationship building and maintenance
- •Researches and analyzes data for evaluating performance of program or program operations, including quality assurance and trends
- •Makes recommendations to leadership and/or implements program changes based on findings
- •Provides data and/or summary findings to program participants, stakeholders, leadership, and/or cross-functional teams
- •Performs quality oversight of clinical trials and external sites to include monitoring progress of screening, enrollment, and data submission
- •Responsible for ensuring protocol compliance and training of staff supporting the program
- •Plans and supports the department/program leaders during an audit, to include direction for audit prep and any required follow up post audit
- •Evaluates requests for program exceptions or changes, and determines response, escalating as necessary
- •Assesses communication and training needs, develops and implements any applicable communication, education, training, on-boarding and/or mentorship pertaining to the program
- •Provides regular communication to departments and leaders across the organization
- •Notifies stakeholders of any changes to the program
- •May work with cross-functional teams across multiple departments to develop communication and training materials
- •In conjunction with leadership, responsible for planning, monitoring, and managing program fiscal budgets and financials, and resolves or escalates issues
- •Responsible for the clinical trial life-cycle of multi-site, investigator initiated trials
- •Including start-up, planning, and management
- •Maintains data system integrity and ensures quality assurance measures are followed based on departmental standard operating procedures
- •May provide ad hoc reporting to support recommendations observed through trend analysis for future planning and enhancements
- •Monitors program to ensure appropriate governance and program compliance with local, state and federal laws; accreditation, professional and regulatory agency standards and licensure requirements
- •Maintains staff and program compliance with organizational policies and procedures
- •Monitors compliance reporting tools and provides summary status reports to the Research Manager, and other stakeholders
- •May manage staff and/or lead the work of others, including some or all of the following: recruitment, on-boarding/off-boarding, training, performance management and professional development of staff
- •32 more items(s)
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