Clinical Research Manager jobs in Lowell, MA

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