• Responsible for the compliance of the clinical study program with regulations and internal procedures.
• Design, manage and report on internal and external clinical studies.
• Manage the budget against the plan for studies.
• Prepare clinical study budget plans and clinical study agreements.
• Manage the identification and qualification of clinical sites and clinical research organizations.
• Lead the management of clinical study audits by internal and external agencies.
• Manage the development and maintenance of standard operating procedures.
• Manage clinical strategy to support product development and market introduction.
• Responsible for compliance with applicable Corporate and Divisional Policies
• Understand project deliverables and achievement of deliverables
• Manage staff following the organization’s policies and applicable regulations
• Closely monitoring work queues and chart inventories to ensure that they are cleared daily.

Skills: Regulatory Compliance, Clinical Study Management, Budget Management, Site and CRO Qualification, Audit Management, SOP Development and Maintenance, Clinical Strategy Management, Staff and Workflow Management

• Contribute to trial synopsis, protocol, and amendments to ensure operational feasibility
• Contribute to defining the Case Report Form content
• Develop study-specific procedures and write the Monitoring Plan and other operational documents
• Coordinate and support field-monitoring activities
• Maintain monthly study highlights (including enrollment curves and timelines) promptly
• Select and hire high-quality staff and develop onboarding processes
• Ensure staff has materials, systems, and training to fill job responsibilities
• Lead clinical resourcing through continual evaluation of existing and future resource alternatives
• Initiate proactive planning and collaboration with leadership and operational peers
• Work collaboratively with project leadership to manage project challenges and achieve exemplary customer service
• Lead or participate in departmental process improvement initiatives
• Work with trial project teams to assess project risks and issues

Skills: Clinical Trial Protocol Development, Case Report Form (CRF) Design, Study Documentation and Planning, Field Monitoring Coordination, Project Tracking and Reporting, Team Development and Onboarding, Resource Management and Planning, Risk Management and Problem Solving

• Developing, documenting, and implementing comprehensive training on Reveleer’s coder tools.
• Improving and updating all training materials and job aides for coders.
• Developing incentive programs to uphold quality results and timely outcomes.
• Translating Technical Specifications for and working with Reveleer’s product development team to ensure that Reveleer’s Medical Record Review platform reflects all new information.
• Building a highly effective QA program that ensures Reveleer abstracts at a 95% accuracy rate or higher.
• Provide senior project management support for an exciting and interesting portfolio of multi-center/national/international clinical trials and clinical studies being undertaken by the CTU. 
• Oversee a range of studies within NHSBT’s therapeutic areas working alongside internal and external stakeholders to ensure study requirements and deadlines are met. 
• Contribute to CTU strategy and direction as an integral member of the CTU Management Team, including decisions about new proposals and collaborations and the subsequent writing of associated grant applications. 
• Lead, mentor and develop a small group of staff including trial managers, trial coordinators and administrators, ensuring they were supported and guided 
• Contribute to the development and maintenance of effective processes for resource and financial planning, trial administration, document management, data management and quality control and assurance.
• Participating in national training programs and conferences both as a participant and as an industry thought leader.

Skills: Training Development and Implementation, Training Material Improvement, Incentive Program Development, Technical Translation and Collaboration, Quality Assurance Program Management, Senior Project Management, Strategic Contribution and Grant Writing, Team Leadership and Development

• Direct management (i.e., training, growth, development, and performance management) of a cross-functional Clinical Operations team.
• Provide leadership in the execution and management of clinical studies by project goals and objectives. 
• Responsible for all aspects of trial setup, budgeting, resource plans, objectives, reporting, etc. from trial concept through to trial completion and coordination across functional areas.
• Oversee study budget planning and management, and be accountable for external spending related to study execution. 
• Ensure development of accurate study budgets, contract development and execution, payment and tracking of study expenditure.
• Tracks progress of studies and addresses problems proactively 
• Develops and utilizes SOPs, systems, and appropriate project management tools for efficiency in clinical study execution.
• Ensures quality and compliance of trial conduct with applicable GCP/ICH guidelines, regulations, SOPs, and other global regulatory requirements. 
• Participates in the planning of quality assurance activities and coordinates the resolution of audit findings.
• Participates in the evaluation, selection, and management of external vendors, including measuring key performance indicators, and proper guidance of performance for activities assigned to vendors for clinical studies.
• Participates and has input in the development of clinical study synopsis and protocol in conjunction with the clinical development plans

Skills: Cross-Functional Team Leadership, Clinical Study Execution, Trial Set-Up and Coordination, Budget Management, Study Progress Tracking, Quality and Compliance Assurance, Vendor Management, Clinical Study Development

• Ensure CRAs are properly and timely trained to perform all types of visits as well as other billable monitoring activities
• Establish regular communication and 1:1 calls with CRAs to review and discuss quality metrics (SVR compliance, SDV metrics, TMF readiness, Expense reports submissions, project status, etc.)
• Review the accuracy of Sciforma assignments and workload
• Conduct performance appraisals, reward and discipline employees, address employee relations issues and resolve problem
• Be responsible for rostering of clinical staff for DE sites ensuring rosters meet regulatory requirements and are distributed to staff on time.
• Ensures all clinical staff in each facility are educated and competent following current DE orientation and training programs.
• Be responsible to maintain the QMS program and to maintain clinical competency in clinical practice.
• Manage the clinical and administrative aspects of the organization, including nursing staff mentoring, pay run and staff credentialing, ordering of supplies, and monitoring income and expenses.
• Be involved in the team responsible for the recruitment of nurses
• Maintain AS4187 and NSQHS standards and Department of Human Services Licensing.
• Request and initiate the purchase of materials, supplies and equipment.

Skills: Training and Development, Performance Management, Communication and Coordination, Workload and Assignment Review, Staff Rostering and Scheduling, Quality Management System (QMS), Clinical and Administrative Management, Standards Compliance and Procurement

• Have trial coordination experience in a clinical research and industry environment
• Advanced degree preferred or Bachelor's in a science-based subject
• Relevant experience in a global setting and a solid understanding of drug development
• Good project management skills
• Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
• Excellent verbal and written communication skills
• Good organizational skills and attention to detail
• Excellent organizational, communication (verbal and written), and interpersonal skills.
• Ability to work independently, prioritize, and function effectively within a matrix team environment.
• Working knowledge of Word, Excel, and PowerPoint.

Qualifications: BS in Nursing with 6 years of Experience

• Previous experience in personnel management within a clinical research environment.
• Previous experience as a Clinical Research Associate/Clinical Monitor, by preference in medical devices, diagnostics, or MedTech.
• Understanding of the entire clinical research process
• Demonstrate the ability to lead and motivate a group of clinical research personnel.
• Track record of advancing quality of care and achievement of performance targets
• Excellent human resource management skills including recruitment and retention of staff
• Excellent budgeting and financial management skills
• Demonstrated commitment to continuing education
• Strong conflict resolution skills
• Patient and family engagement approach

Qualifications: BS in Biology with 7 years of Experience

• Undergraduate degree in a healthcare-related field
• Masters prepared or evidence of substantial completion
• Current member and in good standing with a professional college 
• Have recent experience as a Manager in a similar hospital environment
• Proven leadership skills and ability to motivate
• Ability to inspire others toward professional excellence
• Superior verbal and written communication skills
• Demonstrated change management skills
• Excellent customer service skills
• Demonstrated ability to foster team building
• Ability to learn new technologies and processes very quickly, and without a lot of formal direction or structured coaching

Qualifications: BS in Healthcare Administration with 4 years of Experience

• Experience in Phase 1-2 clinical trial management would be ideal
• Experience in selecting and managing External Service Providers (ESP), including performance assessments and finance management
• Previous experience working with EDC, eTMF, CTMS systems
• Excellent knowledge of ICH-GCP guidelines, and pertinent EU clinical trial regulations
• Working knowledge of relevant US 21 CFR sections
• Excellent communication skills in a multi-stakeholder environment
• Demonstrated leadership and problem-solving skills
• Some experience in an international setting, fluency in English
• Satisfactory employment and attendance record
• Ability to negotiate effectively and influence peers, affiliates and Regulatory agencies to ensure that regulatory and business needs are met.
• Flexibility to provide innovative approaches to gain marketing approvals globally.

Qualifications: BS in Public Health with 5 years of Experience

• Experience in Clinical Research in a medical device or pharmaceutical-regulated industry. 
• Experience as a clinical research associate (CRA).
• Complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP). 
• Strategic & tactical clinical and business knowledge to gain approval and ensure maintenance of the legal marketing status of all products.
• Strong communication, organizational, and interpersonal skills.
• Broad-based technical knowledge and skills in diverse areas of business (e.g., R&D, Operations, QA, laboratory, regulatory, project management, etc.).
• Fluency in Japanese and upper business-level English
• Extensive experience in Clinical Operations
• Preferably experienced in in-house and full-outsourced / IC model
• People leadership/line management capabilities
• Experience in contributing to the establishment of a new organizational structure

Qualifications: BS in Clinical Research with 8 years of Experience