The Clinical Research Manager (CRM) is primarily accountable for end-to-end performance and project management for assigned protocols in a country in compliance with ICH / GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Primary Duties : Main Point of Contact (POC) for assigned protocols and link between Country Operations (CO) and clinical trial team (CTT) Responsible for project management of the assigned studies Proactively plans / drives / tracks execution and performance of deliverables / timelines / results to meet country commitments from feasibility and site selection, recruitment, execution and close out Accountable for performance for assigned protocols in country in compliance with ICH / GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally Performs quality control visits as required Reviews Monitoring Visits Reports (MVRs) and escalates performance issues and training needs to CRA manager and / or functional vendor and internal management as needed Responsible for creating and executing a local risk management plan for assigned studies Ensures compliance with Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF) and other key systems in assigned studies Escalates as needed different challenges and issues to Therapeutic Area (TA) Director / Clinical Research Director (CRD) / Clinical Quality Management (CQM) and or CTT (as appropriate) Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies Country POC for programmatically outsourced trials for assigned protocols Serves local business needs as applicable in his / her country (if delegated can sign contracts and manage budgets) Shares protocol-specific information and best practices across countries / clusters Strong collaboration with local / cluster roles, experience in identifying and sharing best practices across clinical trials, countries, clusters Oversees accountability for country / cluster and site validations, site selection and recruitment in assigned protocols Lead and contribute to initiatives and projects adding value to the business and supporting the strategy Responsible for quality and compliance in assigned protocols in country Coordinate study Clinical Trial Coordinator (CTC), Clinical Trial Associates (CRAs), Clinical Operation Manager (COM) Skills and Education : Bachelor's degree in Science (or comparable) required;
advanced degree (Master's degree, MD, PhD) preferred 5-6 years of experience in clinical research CRA experience preferred Travel expectation is up to 30% of working time LI-REMOTE
Senior Clinical Outsourcing Manager
Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Senior Clinical Outsourcing Unit Manager. Support Clinical Outsourcing Unit (COU) Managers. Design and maintain ...
Clinical Research Manager
Primary Duties: Main Point of Contact (POC) for assigned protocols and link between Country Operations (CO) and clinical trial team (CTT) Responsible for project management of the assigned studies Proactively plans/drives/tracks execution and performance of deliverables/timelines/results to meet cou...
Manager, Clinical Research Technology Hybrid
Under the general direction of the Associate Chief Information Officer or designee, and in collaboration with UMass Chan research leadership, the Manager, Clinical Research Technology is responsible for the planning, design, review, programming and implementation of institutional software and biomed...
Clinical Research Manager I-The Vascular Anomalies Center (VAC)
The Clinical Research Manager within the Vascular Anomalies program is responsible for the oversight of the programs clinical research portfolio and all related regulatory, compliance and performance metrics requirements. BRJob Posting Title:Clinical Research Manager I-The Vascular Anomalies Center ...
Clinical Research Manager (Associate)---Cancer Center Protocol Office
The candidate will also manage a team of clinical research coordinators/research assistants to ensure efficient functioning of the clinical and translational research infrastructure. The candidate will report directly to the Director of the Gastrointestinal Cancer Center Program and will be responsi...
Clinical Research Manager
IRB, Computing, Vice Provost for Research, Research Compliance, Office of Technology Development, research monitors) and the sponsored research team to assist with grant and conflict of interest reporting requirements. During first year, manage the transition of IRB protocols from the Wyss Institute...
Assistant Clinical Research Manager - Pediatric Cancer Predisposition Program | Dana-Farber Cancer Institute
These positions, in collaboration with the program???s Clinical research Managers physicians and research nursing staff, are responsible for assisting with the design, implementation and evaluation of their program???s clinical research activities, related regulatory oversight, and will provide day ...
Process Improvement Manager, Clinical Research Operations
Collaborates with the Senior Director of Clinical Research Finance to implement the Clinical Research Finance roadmap, driving enhancements and efficiencies within study teams. Reporting to the Director of Process Improvement, the Process Improvement Manager supports the design, development, and exe...
Clinical Research Program Project Manager
Clinical Research Program Project Manager-(3302870). Responsibilities include, but are not limited to: ensuring research project deliverables are completed in a timely manner; ensuring seamless communication across project teams; supervising and task management/delegation for research coordinators a...
Senior Clinical Outsourcing Manager
Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Responsibilities: Design and maintain Clinical Outsourcing procedures, trackers, and budget tools Identify, sele...