Job Summary: 

• Serve as the clinical point person managing protocol execution
• Oversee CROs, vendors, and consultants that are involved with the clinical trials and programs
• Lead internal and external clinical study management meetings
• Train internal and external team members
• Perform clinical research site activities, such as onsite/remote and co-monitoring
• Establish study milestones in collaboration with other team members
• Ensure accurate tracking/reporting of study metrics and timelines
• Confirm trial adherence to ICH/GCP/Federal and Global HA regulations
• Assist in the development of study documents such as Informed Consent, Protocol, Investigator Brochure, and study tools
• Support the development of the clinical components of regulatory submissions
• Oversee individual studies and relevant program-related activities
• Respond to Quality Assurance and/or regulatory authority inspection audits
• Participate in contract and budget negotiations with CROs, clinical sites, vendors, and consultants

Skills on Resume: 

• Clinical Trial Management (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Training and Development (Soft Skills)
• Site Management (Hard Skills)
• Project Management (Hard Skills)
• Document Development (Hard Skills)
• Regulatory Submissions (Hard Skills)
• Contract and Budget Negotiation (Hard Skills)

Job Summary: 

• Oversee, plan and manage clinical trials to ensure studies are completed on time/within budget and according to the clinical development strategy to ensure regulatory approvals
• Responsible for study-related in-house collaboration and coordination of cross-functional groups
• Oversee and manage CROs, study contractors and vendors
• Responsible for identifying issues and proposing ideas to manage risks to clinical study/program timelines, budget and corporate goals
• Responsible for the collection of study metrics and developing reports and delivering presentations
• Contribute to the development of other key study documents, including clinical protocol and amendments, investigator brochure, CRFs, data management plan, and clinical study report
• Ensure completeness of the TMFs including review
• Ensure clinical study compliance with SOPs, ICH/GCP guidelines and all applicable regulations
• Ensure appropriateness of IP forecasts and create forecasts for the study
• Coordinate the implementation of CAPAs for IMP shipment/release to warehouse and sites, temp excursions and IMP deviations.
• Manage clinical trial SOW and budgets
• Provide ongoing financial reporting and projections to the manager and finance group

Skills on Resume: 

• Clinical Trial Management (Hard Skills)
• Cross-Functional Coordination (Soft Skills)
• Risk Management (Hard Skills)
• Reporting and Presentation (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Documentation and Protocol Development (Hard Skills)
• Financial Management (Hard Skills)
• Problem Solving and CAPA Coordination (Soft Skills)

Job Summary: 

• Contribute to the development and implementation of clinical trial strategy
• Serve as primary contact/resource to External Service Providers (ESPs) for day-to-day protocol-related issues and propose solutions to maintain projects within designated budget and timelines
• Oversee the development of study-related documents, trial planning, recruitment strategy, site selection, and trial execution according to plan
• Manage and lead team meetings
• Report accurate trial-related information (enrollment, monitoring, regulatory documents, etc.), trend analysis, and risk mitigation
• Review and analyze the data from tables and listings
• Coordinate training programs for clinical trial staff and ESPs prior and during study conduct
• Train the ESP in internal/company clinical data review
• Identify and escalate potential serious compliance issues and assist in the development of action plans
• Communicate and coordinate study-related activities across all relevant cross-functional areas
• Ensure assigned studies are conducted following the protocol, ICH, GCP, and all applicable global regulatory requirements

Skills on Resume: 

• Clinical Trial Strategy Development (Hard Skills)
• Project Management (Hard Skills)
• Team Leadership (Soft Skills)
• Regulatory Compliance and Documentation (Hard Skills)
• Data Analysis and Reporting (Hard Skills)
• Training and Development (Soft Skills)
• Risk Management and Compliance (Hard Skills)
• Cross-Functional Coordination (Soft Skills)

Job Summary: 

• Conduct Monitoring Oversight Visits
• Approve the selection of appropriate clinical staff by the ESP
• Encourage communication and interaction within the project team
• Participate in process and continuous improvement initiatives
• Serve in the Oversight Risk Management role
• Perform regular reviews within the eSource and surveillance systems per the Oversight Risk Plan (ORP) and Integrated Data Review Plan (IDRP) 
• Oversee and ensure quality performance throughout the life cycle of the trial
• Track and analyze data for trends, develop appropriate action plans for risk mitigation strategies, and report outcomes (issues/trends) to the clinical trial team
• Analyze qualitative and quantitative metrics from remote and onsite monitoring visits addressing and resolving issues through risk mitigation strategies
• Implement the ORP and the Trial Master File (TMF) Plan for assigned trials
• Support the Clinical Trial Team (CTT) in preparing for internal/external audits and develop or assist in the implementation and management of CAPAs
• Join in User Acceptance Testing (UAT) for assigned trial to ensure technology integration is in alignment with the trial protocol

Skills on Resume: 

• Clinical Oversight and Monitoring (Hard Skills)
• Risk Management and Mitigation (Hard Skills)
• Quality Assurance and Performance Management (Hard Skills)
• Data Analysis and Reporting (Hard Skills)
• Process Improvement (Hard Skills)
• Communication and Team Collaboration (Soft Skills)
• Regulatory Compliance (Hard Skills)
• Technology Integration and Testing (Hard Skills)

Job Summary: 

• Partners with International Regulatory Managers and EU Regulatory Program Managers on the regulatory management of Clinical Trial Applications in EU and International countries.
• Coordinate with internal departments and affiliates to plan, compile, dispatch and track submissions and approvals of core CTAs or common documents and amendments for EU and international countries, using the appropriate systems
• Provide expert advice to EU Regulatory Program Managers and International Regulatory Managers on external and internal requirements for CTAs and monitor the regulatory landscape for changes
• Apply and follow-up PDR Quality Principles on RFT (right first time) on delivering quality documentation
• Attend Study Leadership Team (SLT) meetings (in the planning phase of a clinical trial and further) in agreement with the Program Managers
• Interact with CROs and affiliates for specific CTA-related activities
• Work with the Group Managers on workload management
• Update and maintain the CT-related internal process documents as well as knowledge-sharing and training activities
• Participate in projects and initiatives outside of the core scope of Clinical Trial Regulatory Lead responsibilities.

Skills on Resume: 

• Regulatory Expertise (Hard Skills)
• Coordination and Planning (Hard Skills)
• Quality Management (Hard Skills)
• Stakeholder Engagement (Soft Skills)
• Project Management (Hard Skills)
• Process Improvement (Hard Skills)
• Adaptability and Problem-Solving (Soft Skills)
• Cross-Functional Collaboration (Soft Skills)