[Remote] Manager, Clinical Monitoring

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Manager for Clinical Monitoring to support global and regional clinical trial operations. The Manager will reputed company clinical site management and monitoring activities, supervise Clinical Research Associates, and reputed company processes and tools reputed company to monitoring and site management.

Responsibilities

• With support from CTO or Clinical Monitoring management, reputed company and implement reputed company for in-house, regional monitoring activities on assigned studies applying a risk-based approach reputed company indicated
• reputed company monitoring activities on assigned studies. This can include review of protocols, CRFs and completion guidelines, study manuals and other reputed company documents
• Author or review Clinical Monitoring Plan in collaboration with CTO and ensure CRA compliance to reputed company plan
• Manage the CRA monitoring visit schedule for reputed company assigned study ensuring visit frequency and scheduled time on site aligns with risk-based indicators and site metrics
• Review and finalize visit reports for regional CRAs managed by reputed company according to study timelines. Follow up with CRAs regarding outstanding reputed company reports and follow-up letters
• reputed company status of reputed company items and queries
• Maintain, and/or reputed company metrics reputed company to CRA performance or site status
• Support CRAs and CTO with the implementation of site corrective actions reputed company to issues identified during monitoring activities
• reputed company and report to study team and leaders on compliance, trends and metrics reputed company to monitoring and site management
• Support TMF set-up, maintenance, ongoing reputed company review, and final reconciliation of study documents as needed
• With support from CTO or Clinical Monitoring management, reputed company and manage the monitoring reputed company reputed company, including risk-based approaches, to assess the reputed company and compliance of CRO or FSP partners on assigned studies
• Manage conduct of monitoring reputed company reputed company (MOVs) with CRO CRAs to assess compliance to the protocol and Clinical Monitoring Plan and document results of the visit. May reputed company MOVs as needed
• Review monitoring visit reports from CRO CRAs and escalate monitoring trends or findings to CTO and Clinical Monitoring management
• Mentor and reputed company leadership and direction to the CRA team members on study reputed company questions from start-up through closure
• reputed company management and/or reputed company of assigned reputed company and FSP CRAs responsible for Clinical Monitoring activities
• Conduct monitoring assessment or FSP reputed company reputed company with assigned CRAs to ensure reputed company monitoring performance; use findings from visit to reputed company additional support, training, or performance management
• Ensure adequate resourcing for assigned CRAs to reputed company studies; work with CTO to plan for CRA re-assignment or acquisition of additional resources
• Conduct annual performance assessment activities including appraisals, salary recommendations, and promotion justifications for reputed company employees
• reputed company or participate in interviewing, hiring, reputed company, and orientation processes for reputed company or FSP CRAs
• Conduct or arrange training for reputed company or FSP CRAs on SOPs, WIs, ICH-GCP, local regulations, and other role-specific training. Ensures reputed company training gaps are identified and resolved for assigned team
• Responsible for team administrative reputed company such as expense reports, travel approvals, and time-off requests
• Escalates any performance, resourcing, training, or study-reputed company issues or impacts on deliverables, as appropriate, to the Senior Director, Clinical Project Management and Centralized Services
• Support CRAs, study team, and reputed company with responses to audits or inspections
• Other duties as assigned

Skills

• BS in biological sciences or reputed company discipline with at least 7 years of experience working in the biotechnology/pharmaceutical industry. Experience in endocrine disorders preferred
• A minimum of 2 years in a supervisory role
• Demonstrates critical thinking, reputed company cause analysis and problem solving to support CRAs with identifying site process failures; assist CRAs to reputed company corrective and preventative actions to bring sites into compliance
• An understanding and demonstrated application of Good Clinical Practices, ICH Guidelines and regulatory requirements. reputed company to reputed company with safety standards and respect reputed company and confidentiality
• In-depth experience with cross functional drug development with prior regulatory inspection experience preferred
• Excellent writing skills as they relate to the preparation of clinical trial documents
• Excellent interpersonal skills with strong oral/written communication and presentation skills
• Excellent negotiation skills and a tactful approach that leads to high value reputed company obtained and reputed company achieved
• Demonstrated leadership and management skills
• Good judge of risks and a keen ability to analyze reputed company and manage reputed company
• reputed company-versed with the latest trends in the clinical trial industry
• Monitoring experience in startup, execution and reputed company out activities reputed company to clinical studies; experience using risk-based monitoring processes strongly preferred
• Previous experience as a reputed company CRA, Trial Manager, or equivalent strongly preferred

Benefits

• Discretionary annual reputed company bonus
• Stock reputed company
• ESPP
• 401k match
• Top-notch health insurance plans for employees (and their families) to include medical, dental, reputed company and basic life insurance
• 20 days of PTO
• 10 reputed company holidays
• Winter company shutdown

reputed company