Job Summary: 

• Act as specific study leader for developing operation manuals/tools, performing co-monitoring visits, budget control, etc
• Execute clinical trials to produce high-quality data on schedule to satisfy regulatory and registration strategy requirements
• Maintain an overview of status, issues, and risks and proactively communicate progress, issues, changes, or risk mitigation strategies that may impact timelines and costs of the project to the CT manager
• Contribute country-specific aspects in the development of the protocol, protocol revisions, amendments and CRF design
• Prepare and review clinical study agreements and budgets with the CT manager and Contracts group
• Responsible for the management of designated sites in clinical trials, including IRB/EC submission, investigator meeting/training, enrollment/testing, quality control, site closure, etc
• Be responsible for source data/documents verification/review, and make sure the data/documents are attributable, legible, contemporaneous, original and accurate
• Assess patient recruitment strategies
• Take responsibility for preparing feasibility questionnaires
• Evaluation of potential clinical sites to determine if the sites and investigators meet study requirements
• Contact clinical investigators, physicians, and technical specialists regarding feasibility matters

Skills on Resume: 

• Clinical Trial Management (Hard Skills)
• Project Coordination (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Data Verification and Quality Control (Hard Skills)
• Feasibility Assessment (Hard Skills)
• Budget Management (Hard Skills)
• Training and Development (Soft Skills)
• Communication Skills (Soft Skills)

Job Summary: 

• Adhere to Clinical Standard Operating Procedures and Good Clinical Practice ICH Guidelines
• Assist in contacting investigator sites to provide study-specific information
• Ensure receipt, completeness and accuracy of clinical and administrative documents
• Coordinate distribution and shipment of study-related materials
• Coordinate investigator site/payment 
• Maintain telephone contact with sites, contract research organization personnel, vendors and CRAs
• Facilitate flow and maintenance of correspondence with sites
• Attend clinical project team meetings and take minutes
• Contract, invoice and budget management and tracking
• Assist in the coordination of study initiation documentation materials

Skills on Resume: 

• Clinical Trial Management (Hard Skills)
• Communication Skills (Soft Skills)
• Document Management (Hard Skills)
• Coordination and Logistics (Hard Skills)
• Meeting Facilitation (Soft Skills)
• Budget and Financial Management (Hard Skills)
• Organizational Skills (Soft Skills)
• Vendor and Stakeholder Relations (Soft Skills)

Job Summary: 

• Responsible for compiling/QC checking/generating copies of clinical documents that are intended for submissions including 1572s (original and updated), Informed Consent Form, Protocol and Investigator’s Brochure
• Coordinate distribution of study team materials and meeting minutes
• Draft and prepare documents for mass mailings (e.g., protocol amendments)
• Assist with the preparation of presentation materials
• Maintain a central registry of contact information for clinical sites, contract research organizations, vendors and CRAs.
• Set up teleconference calls with sites and teams and record minutes
• Maintain a central monitoring calendar for all site visits
• Create and maintain Central Clinical files
• Preparation and maintenance of investigator tracking logs
• Perform administrative and clerical duties

Skills on Resume: 

• Document Management (Hard Skills)
• Coordination and Distribution (Soft Skills)
• Drafting and Preparation (Hard Skills)
• Database Management (Hard Skills)
• Teleconference Management (Soft Skills)
• Scheduling and Tracking (Hard Skills)
• File Maintenance (Hard Skills)
• Administrative Support (Soft Skills)

Job Summary: 

• Review Real Estate contracts, and Title Commitments to ensure all title requirements are met
• Prepare Settlement Statements, closing documents
• Take responsibility for proper file balancing before closing
• Present final closing documents to Seller/Buyers
• Prepare and submit closed loan package, disbursement documentation and funds, and submission of post-closing documents to appropriate departments
• Daily contact and communication with customer base
• Respond in a timely, professional and courteous manner to any customer inquiries
• Grow and maintain client relationships and develop new client relationships
• Responsible for branch capture rate goals
• Participate in client events and meetings

Skills on Resume: 

• Contract Review and Compliance (Hard Skills)
• Documentation Preparation and Management (Hard Skills)
• File Balancing and Reconciliation (Hard Skills)
• Client Communication and Service (Soft Skills)
• Relationship Building and Client Retention (Soft Skills)
• Event Participation and Networking (Soft Skills)
• Organizational Skills (Hard Skills)
• Customer Service and Problem-Solving (Soft Skills)

Job Summary: 

• Take responsibility for the management and tracking of vendors
• Manage all aspects of change orders, invoices and investigator payments
• Develop country and site-specific Informed Consent Forms (ICFs)
• Contribute to the management of country and site-level feasibility assessments
• Contribute to the management of budget and contract negotiations in collaboration with the legal department
• Support the management of regulatory document collection
• Contribute to the management of IRB and EC submissions through to approval
• Prepare site staff and CRO training and investigator meeting materials
• Maintain study status updates, support close-out activities
• Review monitoring visit reports and perform monitoring oversight when required alongside the Clinical Operations Lead
• Review scientific literature and treatment guidelines, collect information about target indications

Skills on Resume: 

• Vendor Management (Hard Skills)
• Financial Administration (Hard Skills)
• Regulatory Documentation (Hard Skills)
• Feasibility Assessment (Hard Skills)
• Contract Negotiation (Hard Skills)
• Training and Education (Hard Skills)
• Monitoring and Oversight (Hard Skills)
• Literature Review and Research (Hard Skills)

Job Summary: 

• Coordinates feasibility process for proposed and assigned trials 
• Provides ongoing site management to ensure project completion within designated timelines
• Establish and maintain the Trial Master File (TMF)
• Take responsibility for Essential Documents – Site Startup
• Collect Essential Documents from site during site startup
• Compile/prepare/submit Essential Document Package (EDP) for regulatory readiness
• Ensure quality product deliverables at all times
• Setup and manage the Study Portal
• Setup and manage trackers as assigned by PM/CTM
• Maintains a professional approach respecting the dignity and confidentiality of associates, managers, and vendors
• Review and analysis of study documents, research on study drugs, evaluation of eligibility criteria and study procedures

Skills on Resume: 

• Project Management (Hard Skills)
• Document Management (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Site Management (Soft Skills)
• Analytical Skills (Hard Skills)
• Attention to Detail (Soft Skills)
• Communication Skills (Soft Skills)
• Technical Proficiency (Hard Skills)

Job Summary: 

• Collaborating with the Chief Medical Officer to design and initiate clinical trials according to business regulatory strategy
• Creating and implementing all relevant clinical trial documentation, including protocols, statistical plans and patient-facing documentation
• Operational management of all clinical trial activities, including site selection, set up, conduct, monitoring and closure of trials following ICH-GCP and applicable local regulations
• Clinical trial budget management and reporting
• Identifying and managing working relationships with Contract Research Organisations where indicated to ensure timely delivery of clinical trials
• Developing standard operating procedures to ensure all trial activities are delivered to the highest regulatory standards
• Working with the clinical data and regulatory teams to ensure appropriate reporting of clinical trial outcomes, including statistical analysis
• Working with stakeholders from across the company and externally to deliver clinical trial objectives
• Leading and developing a small clinical trials team
• Bringing scientific and regulatory rigor to all elements of work

Skills on Resume: 

• Clinical Trial Design and Documentation (Hard Skills)
• Operational Management (Hard Skills)
• Budget Management (Hard Skills)
• Contract Research Organization (CRO) Management (Hard Skills)
• Standard Operating Procedures (SOP) Development (Hard Skills)
• Data and Regulatory Reporting (Hard Skills)
• Stakeholder Collaboration (Soft Skills)
• Leadership and Team Development (Soft Skills)