Clinical Trial Manager, Senior
Location
North America
Posted
8 days ago
Salary
$140K - $180K / year
Seniority
Senior
Job Description
Clinical Trial Manager, Senior
BBOT
• Support the Director in overseeing global clinical trial execution, including site activation, enrollment, monitoring, and closeout • Support the Director in leading cross functional trial team meetings and ensure alignment on key deliverables, timelines, and risk mitigation strategies • Manage day-to-day operational activities for assigned studies, ensuring adherence to timelines, budgets, and quality standards • Drive vendor integration strategies to ensure seamless execution between CRO, central labs, and any specialty service providers • Act as the main clinical operations point of contact for assigned study-level tasks, including managing CROs and vendors in collaboration with the Director • Ensure completeness and inspection-readiness of the trial master file (TMF/eTMF) • Support the development and maintenance of key operational documents including study manuals, ICFs, tracking tools, and monitoring plans • Participate in the conduct of audits and support regulatory inspections related to GCP • Monitor regulatory and GCP compliance across trial activities and support audit/inspection readiness • Review clinical trial data listings to support identification and resolution of protocol deviations, data trends, and outstanding queries • Own CRO and vendor oversight by tracking deliverables, proactively identifying risks until issue resolution, and performance metrics in partnership with the Program/Study Lead • Oversee lab sample management processes, including sample tracking, shipment, reconciliation, and vendor coordination to ensure timely and compliant handling of biological specimens • Contributes to continuous process improvement and SOP development • Participate in team meetings, providing clinical operations insights and updates to internal stakeholders
Job Requirements
- Bachelor’s degree in life sciences or related field
- Minimum 4 years of experience in Clinical Operations, working with CROs and other vendors
- Strong understanding of CRO/vendor oversight and clinical development process
- Early-phase oncology experience preferred
- Prior experience in a lean or startup environment is highly desirable
- Excellent project management, communication, and problem-solving skills
- Working knowledge of ICH-GCP and global regulatory requirements
- Proficient in clinical trial systems (e.g., EDC, CTMS, eTMF) and Microsoft Office Suite
Related Guides
Related Categories
Related Job Pages
More Clinical Research Jobs
Clinical Dietitian II
Baylor Scott & White HealthBaylor Scott & White Health, formerly known as Baylor Health Care System, is a leading Texas-based nonprofit healthcare system. Baylor Scott & White Health was
Title: Clinical Dietitian 2 REMOTE Location: Remote, United States Category Patient & Clinical Support Job Type Full Time Day Job Job Id26010403 Job Description: REMOTE Clinical Dietitian II Vasicek Cancer Center Temple, TX About Us Here at Baylor Scott & White Health we promote the well-being of all individuals, families, and communities. Baylor Scott and White is the largest not-for-profit healthcare system in Texas that empowers you to live well. Our Core Values are: - We serve faithfully by doing what''s right with a joyful heart. - We never settle by constantly striving for better. - We are in it together by supporting one another and those we serve. - We make an impact by taking initiative and delivering exceptional experience. Benefits Our benefits are designed to help you live well no matter where you are on your journey. For full details on coverage and eligibility, visit the Baylor Scott & White Benefits Hub to explore our offerings, which may include: - Immediate eligibility for health and welfare benefits - 401(k) savings plan with dollar-for-dollar match up to 5% - Tuition Reimbursement - PTO accrual beginning Day 1 Note: Benefits may vary based upon position type and/or level. Job Summary The Clinical Dietitian II provides nutrition therapy and education to patients, families, and the community. Performs nutritional assessments of patients and develops care plans. Develops and conducts educational and in-service training programs. Participates in multidisciplinary patient rounds and case conferences. Essential Functions of the Role - Conducts patient nutrition assessments for low and high acuity patients. This includes both inpatient and outpatient care. Utilizes assessment techniques considering age-specific needs and cultural, religious, and ethnic concerns. - Provide timely documentation summarizing the nutrition care plan in the patient''s medical record. Include nutrition assessment, diagnosis, plan, implementation, and progress toward goals. - Assesses educational needs and identifies barriers to learning. Provides nutrition counseling for individuals and groups, considering necessary teaching method adaptations. Educates both low and high acuity patients within practice scope. Facilitates education to ensure compliance with food safety, sanitation, and workplace safety standards in the Food and Nutrition Department, if applicable. - Evaluates achievement of learning targets by the patient and family. Provides follow-up based on the patient''s treatment goals. Refers patient for outpatient counseling, community, or home health services, as appropriate. Conducts ongoing evaluations for a correct nutritional diagnosis of the patient''s problems and progress. Maintains safety and professional standards. - Interacts with medical and food staff to ensure medical nutrition therapy conformance. Interacts effectively with teams to provide integrated patient care compatible with medical and nutritional goals. - Runs team conferences and provides food and nutrition-related in-services to other medical staff as required. - Assists in developing nutritional care and research protocols. Participates in quality assurance by helping develop patient care criteria and examining actual care delivered. - Participates in organizing and executing health fairs and other related community events. - Assists in the development, research, and revision of facility policies. Key Success Factors - Accountable for the proper use of patient protected health information. - Ability to deal with complex situations and resolve patient and customer service concerns. - Ability to give clear, concise, and complete education and instructions. - Works well in a patient-centered environment as an integral team player. - Ability to adjust communication style for different audiences. Caring listener, sensitive, upbeat, optimistic, articulate, gracious, and tactful. Ability to calm upset patients with a composed and professional demeanor. - Licensed Registered Dietitian preferred. Belonging Statement We believe that all people should feel welcomed, valued and supported. QUALIFICATIONS - EDUCATION - Bachelor''s - EXPERIENCE - 2 Years of Experience CERTIFICATION/LICENSE/REGISTRATION - Registered Dietitians (RD)
Principal Biostatistician – Chemistry, Manufacturing and Control
Clinical Outcomes SolutionsA global research consulting group providing 360° support & services across all facets of clinical outcomes research.
• Provide statistical support for CMC-related studies, including formulation development, stability studies, process validation, and analytical method validation. • Collaborate with cross-functional teams, including analytical scientists, process engineers, and regulatory affairs, to develop and implement appropriate statistical strategies. • Design and analyze experiments using linear mixed models, particularly for stability and variability analyses. • Perform statistical modeling, data visualization, and simulations using R programming. • Experience with Bayesian methods preferred. • Ensure quality and compliance with internal standards and regulatory guidelines (e.g., FDA, EMA, ICH).
Senior Clinical Research Coordinator - Hematology, Oncology
University of CaliforniaSince 1869, the University of California has been providing excellent college educational programs for students seeking bachelor's to doctoral degrees. The Univ
Title: Senior Clinical Research Coordinator - Hematology, Oncology Work Location: Santa Monica, CA, USA Onsite or Remote Flexible Hybrid Work Schedule Monday – Friday, 8:00am - 5:00pm Posted Date 06/25/2026 Salary Range: $82705.68 - 133068.24 Annually Employment Type 2 - Staff: Career Duration Indefinite Job # 31477 Primary Duties and Responsibilities Press space or enter keys to toggle section visibility The Senior Clinical Research Coordinator plays a critical role in the overall operational management of clinical research/trial/study activities from design, set up, conduct, through closeout. The ideal candidate is an experienced professional or leader who has direct responsibility for the implementation of research activities for one or more studies which may include multicenter clinical trials (both NIH and industry-sponsored), local investigator-initiated clinical trials, and/or programmatic clinical research activities. Recognize and perform necessary project management tasks and prioritizes work to reach scheduled goals. The Senior Clinical Research Coordinator is a technical leader responsible for ensuring the study protocol and procedures have been completed accurately, safely, and in a timely manner. This position may supervise and train others on projects as necessary. Work with PIs, departments, sponsors, institutions, and other entities as needed to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of studies. Annual salary range: $93,927.51 - $151,099.73. Job Qualifications Press space or enter keys to toggle section visibility Required: - Minimum of 4+ years of experience in a clinical research setting - Interpersonal skills to effectively communicate information in a timely, professional manner and establish and maintain cooperative and effective working relationships with students, staff, faculty, external collaborators and administration and to work as a member of a team. - Ability to effectively communicate to and interact with patients in a compassionate and kind manner. - Ability to set priorities and complete ongoing tasks with competing deadlines, with frequent interruptions, to meet the programmatic and department needs, while complying with applicable University policies and federal and state regulations. - Analytical skills to assess clinical research protocols and regulatory requirements, define problems, formulate logical solutions, develop alternative solutions, make recommendations, and initiate corrective actions. - Close attention to detail to ensure accuracy in a fast-paced, fluctuating workload environment. - Organization skills to create and maintain administrative and regulatory files effectively as well as independently balance the various tasks to ensure deadlines are met. - Demonstrated proficiency with Adobe and Microsoft suite software, especially Excel, to perform daily tasks efficiently and accurately. - A learning and professional growth mentality so that new software tools, systems, and processes can be adopted quickly and efficiently. - Knowledge of and experience working with a variety of local and external IRBs, scientific review and other research committees, national cooperative group sponsors, industry sponsors, federal and foundation funding organizations, etc. - Strong verbal and written communication skills to effectively establish rapport, building collaborative relationships, and communicate complex concepts and ideas in an easy-to-understand manner. - Ability to adapt to changing job demands and priorities, remain flexible including working flexible hours to accommodate research deadlines. - Ability to handle confidential information with judgement and discretion. - High degree of concentration and focus in a work environment that contains distracting stimuli, competing deadlines, and work delegated by more than one individual. - Availability to work in more than one environment, travelling to various clinic sites, meetings, conferences, etc. - Strong knowledge of and experience working with a variety of local and external IRBs, scientific review and other research committees, national cooperative group sponsors, industry sponsors, federal and foundation funding organizations, etc. - Strong knowledge of clinical research concepts, policies and procedures, and human safety protection regulations and laws. - Ability to think creatively to develop solutions affecting the full team. - Experience with FDA processes and procedures. - Sufficient experience and knowledge of clinical trials budgeting processes to manage the preparation of clinical trials budgets. Preferred: - Bachelor’s Degree in related area and/or equivalent combination of education and experience. Advanced degree preferred As a condition of employment, the final candidate who accepts an offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; or have filed an appeal of a finding of substantiated misconduct with a previous employer. Current/former UC employees are subject to a personnel file review.
Clinical Research Coordinator - Pediatrics
UCLA Health SystemUCLA Health System provides top-tier healthcare and cutting-edge medical technology to the Los Angeles, California, region and beyond. The academic medical cent
Title: Clinical Research Coordinator - Pediatrics Location: Los Angeles United States Salary Range: $36.37 - 58.52 Hourly Job #: 29178 Job Description: Primary Duties and Responsibilities Press space or enter keys to toggle section visibility The Clinical Research Coordinator will join a centralized clinical research team conducting clinical trials across multiple pediatric sub-specialties. Under the direction of the Clinical Research Supervisor, the Clinical Research Coordinator will manage and coordinate clinical trial activities. Responsibilities include, but are not limited to, participant recruitment, assessment of trial eligibility, enrollment, coordination of research visits, collection and management of participant source documents, regulatory submissions and file maintenance, data management, and specimen handling. The Clinical Research Coordinator is responsible for adhering to institutional and federal clinical research requirements and ensuring studies are conducted in accordance with study protocols and Good Clinical Practice. This role requires the ability to adapt to changing priorities and work flexible hours to meet research deadlines. Travel to other locations may be required. This position is primarily on-site at the UCLA Westwood campus. This is a limited position that may convert to career. Salary Range: $36.37 - $58.52 Hourly Job Qualifications Press space or enter keys to toggle section visibility Required: - Bachelor’s degree or 2+ years of previous study coordination or clinical research coordination experience - Interpersonal skills to effectively communicate information in a timely, professional manner and establish and maintain cooperative and effective working relationships with students, staff, faculty, external collaborators, and administration and to work as a member of a team. - Ability to effectively communicate and interact with patients in a compassionate and kind manner. - Ability to set priorities and complete ongoing tasks with competing deadlines, with frequent interruptions, to meet the programmatic and department needs, while complying with applicable University policies and federal and state regulations. - Analytical skills to assess clinical research protocols and regulatory requirements, define problems, formulate logical solutions, develop alternative solutions, make recommendations, and initiate corrective actions. - Close attention to detail to ensure accuracy in a fast-paced, fluctuating workload environment. - Organization skills to create and maintain administrative and regulatory files effectively as well as independently balance the various tasks to ensure deadlines are met. - Demonstrated proficiency with Adobe and Microsoft suite software, especially Excel, to perform daily tasks efficiently and accurately. - A learning and professional growth mentality so that new software tools, systems, and processes can be adopted quickly and efficiently. - Working knowledge of clinical research concepts, policies and procedures, and human safety protection regulations and laws. - Strong verbal and written communication skills to effectively establish rapport, building collaborative relationships, and communicate complex concepts and ideas in an easy-to-understand manner. - Ability to adapt to changing job demands and priorities, remain flexible including working flexible hours to accommodate research deadlines. - High degree of concentration and focus on a work environment that contains distracting stimuli, competing deadlines, and work delegated by more than one individual. - Availability to work in more than one environment, travelling to various clinic sites, meetings, conferences, etc. Preferred: - Knowledge of and experience working with a variety of local and external IRBs, scientific review and other research committees, national cooperative group sponsors, industry sponsors, federal and foundation funding organizations, etc. As a condition of employment, the final candidate who accepts an offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; or have filed an appeal of a finding of substantiated misconduct with a previous employer.



