• Be in close contact with the Scientific Claim Manager for the organization and operation of the clinical plan
• Set up, execute, and follow up on the clinical program within budget and timelines
• Operate within the Process defined for the different activities
• Select qualified CROs for the realization of the clinical studies
• Coordinate the activities and oversight of the CROs for the execution of the clinical studies
• Work closely with the Medical Expert and Safety Assessor for the safety of the clinical studies
• Inform the clinical Safety group in case of any Related AE/SAE and/or Pregnancy according process described in Safety SOPs
• Collaborate with the Clinical Trial Administrator to ensure appropriate administration of the clinical studies
• Participate in task force representing Consumer Clinical Development interests
• Ensure all clinical staff comply with applicable departmental standard operating procedures 

Skills: Clinical Program Management, Process Adherence, Vendor Management, Coordination and Oversight, Medical and Safety Collaboration, Clinical Trial Administration, Cross-functional Team Collaboration, SOP Compliance

• Provide relevant information to the Scientific Claim Manager for clinical plan setup
• Propose optimization of the clinical plan
• Coordinate operational activities with the Clinical Operations Manager to ensure sufficient resources and budget to achieve project plan deliverables
• Ensure regular and consistent communication between the Scientific Claim Manager and Clinical Operations
• Update project milestones, clinical planning tools or organizational tracker (costs, resources, and timing) as per internal processes
• Report to the Clinical Operations Manager on ongoing activities, alert when issues are raised, and propose corrective actions
• Actively contribute to the preparation of the summary of results and presentation for claim validation at the end of the project.
• Identify variances and present solutions/alternatives by optimizing the clinical plan in collaboration with the project planning and Clinical Operations Manager
• Review clinical trial documents
• Ensure maintenance (and timely review) of departmental standard operating procedures

Skills: Clinical Project Management, Communication Skills, Budget Management, Problem-Solving, Clinical Plan Optimization, SOP Compliance, Reporting and Documentation, Regulatory Knowledge

• Responsible for planning and scheduling project timelines.
• Developing cross-functional project plan.
• Communicate resource requirements and define project tasks accordingly.
• Coordinate and assemble project staff.
• Develop and manage risk mitigation strategies for projects.
• Track and communicate project progress with other teams, as well as stakeholders.
• Responsible for any change order requests.
• Create and communicate progress reports.
• Be accountable for all project deliverables.
• Plan and schedule project timeline.
• Participate in bid-defense meetings.

Skills: Project Planning and Scheduling, Cross-Functional Collaboration, Resource Management, Team Coordination, Risk Management, Project Progress Tracking, Change Management, Reporting and Accountability

• Responsible for the management of clinical study throughout the whole cycle, including site initiation, execution, monitoring, and close out. 
• Ensure the study quality meets the requirements of CFDA regulation, GCP, and 3M internal SOPs.
• Deeply collaborate with clinical investigators to explore and complete the study protocol design
• Coordinate between Leading PIs and other PIs to move the projects smoothly forward
• Aid manager in screening, selecting and evaluating CROs
• Effectively managing CRO to deliver stage milestones and whole project target in a quality and timely manner
• Select and evaluate the qualification of data management and statistic vendors, and build a collaboration partnership
• Lead the clinical pathway decision for new product registration as a local clinical research expert
• Be capable of effective communications with regulatory affairs, business teams, global teams and the relative stakeholders alike
• Utilize and leverage the internal and external resources to complete the clinical evaluation reports per NMPA regulations and format
• Profoundly understand the unmet needs of the business team, and innovate and grope new research models and methods.

Skills: Clinical Study Management, Protocol Design and Collaboration, Project Coordination and Leadership, Vendor Management, Regulatory Compliance and Communication, Clinical Pathway Decision-Making, Resource Utilization and Innovation, Quality Assurance and Risk Management

• Manage, lead and take over responsibility for a clinical study over its entire life cycle
• Coordinate project organization, implementation, and management activities
• Serve as client contact at the project operational level
• Prepare and maintain trial plans, oversee and maintain resources and budgets
• Oversee study start-up and monitoring of sites
• Manage and document project activities, progress and milestones
• Evaluate and manage project budget and scope of work against project milestones
• Conduct study visits on an as-needed basis
• Lead, train and oversee a global, multidisciplinary trial team
• Manage allocated studies according to project timelines and client quality standards
• Direct the technical and operational aspects of projects to secure the successful completion of clinical trials

Skills: Project Management, Team Leadership, Client Relationship Management, Budget and Resource Management, Trial Planning and Oversight, Risk Management, Documentation and Reporting, Clinical Trial Operations

• Managing and leading all aspects of clinical study projects from study planning to close-out and study report
• Working closely with cross-functional teams at Bioinvent (e.g. with manufacturing, pre-clinical, regulatory affairs, and clinical pharmacology)
• Selection and oversight of the performance of Clinical Research Organizations (CROs) and other vendors
• Oversight and regular reporting of study progress to ensure successful completion within agreed timelines/ milestones and budget
• Study site selection and performance and participation in site visits
• Participate in establishing, monitoring, and maintaining procedures to ensure the program meets all GCP/ICH Guidelines
• Supporting in maintaining BioInvent’s relationship with KOLs and PI’s
• Co-development and review of study documents
• Routinely review study data and progress of EDC entry, work with data management and clinical sites to resolve data
• Provide accurate hour forecasts, review pass-through costs and ensure timely invoicing
• Work closely with finance and legal to manage contractual aspects of the study including subcontracting invoices, establishing investigator grants, and negotiating investigator grants

Skills: Project Management, Cross-functional Collaboration, Vendor Management, Progress Monitoring and Reporting, Site Management and Quality Assurance, Regulatory Compliance, Stakeholder Relationship Management, Documentation and Contract Management

• Conducts activities to ensure adherence to the scope of work, timelines and budget for assigned projects
• Schedules weekly team meetings and produces minutes and action plans
• Reviews and coordinates internal project team and external vendor project deliverables, ensuring standard processes are followed. 
• Ensures deliverables are met on time and with appropriate quality
• Assists with site identification and selection
• Creates study & site training materials, and participates in on-site or remote site initiation training 
• Proactively identifies project issues and works with the Senior Director and team members to define mitigation strategy and approach
• Responsible for negotiation of site agreements, budgets, and customization of site informed consent
• Defines IRB/EC submission components and supports the approval process
• Collects, reviews, and files regulatory documents for IRB/EC and RA submissions, including ongoing study maintenance (i.e., yearly renewals, etc.)
• Oversees site management and monitoring, including review and resolution of EDC data queries

Skills: Project Management, Meeting Coordination and Documentation, Vendor Management, Quality Assurance, Site Selection and Management, Training and Development, Problem Solving and Strategy Development, Regulatory Compliance

• Participates in the development and review of accompanying study materials (e.g., questionnaires, informed consent forms, etc.)
• Ensures appropriate project documentation is maintained, including Trial Master File content and maintenance. 
• Ensures materials are saved in shared folders in compliance with SOP
• Plans, develops agenda and materials and works with outside parties as appropriate (e.g., event planner, venue) for investigator meetings
• Assist in the preparation of proposals, including pricing and scoping of external components (i.e., validated scales, vendor costs)
• Attends and presents as main client contact during proposal and/or bid defense meetings to gain awarded work
• Designated as the direct point of contact for client
• Prepares status reports to clients as well as internal parties regularly
• Updates Senior Director regularly on project progress, and escalates issues 
• Manages communication with internal teams such as Finance, Engagement Services, etc. regarding project status, deliverables, etc.
• Assists in the management of contractual and financial aspects of assigned projects, including managing within study budgets and scope of work.
• Supports internal and client financial tracking and reporting, including revenue recognition forecasting, expense management and client invoicing

Skills: Project Documentation Management, Event Coordination and Planning, Proposal Development, Client Relationship Management, Communication and Reporting, Financial Oversight and Contract Management, Cross-Functional Team Coordination, Risk Management and Problem Solving

• Working experience as a Medical Healthcare Professional.
• Experience in all operational aspects of managing clinical trials
• Experience monitoring Medical Device/Pharma studies
• Previous medical device working experience
• Proficiency in resource planning and financial management (clinical trial budgeting)
• Previous Clinical experience managing cross-functional study teams or CROs in the conduct of US IDE, NDA, or other federal regulatory agency product approval studies
• Have a certified Clinical Research Associate (CCRA certification), and Project Management Professional Certification
• Must have a demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations.
• Well organized and detail-oriented, and strong written and verbal communication skills.
• Effective process and project management skills.
• Previous experience within a Sponsor organization or a Clinical Research Organization
• Demonstrated problem-solving abilities in overseeing clinical studies.

Qualifications: BA in Clinical Research with 9 years of Experience

• Excellent knowledge of Good Clinical Practice, the Data Protection Act and the Medicines for Human Use (Clinical Trials) Regulations 2004
• Experience in managing a large multi-center trial or complex interventions, from inception through to completion
• Strong delegation skills and ability to develop and implement robust procedures to support individuals within the full capacity of their role
• Ability to produce appropriate trial management written procedures and implement them and show attention to detail and high standards of accuracy in all aspects of work
• Experience in providing supervision/line management to multidisciplinary teams/staff and managing varied workloads
• Experience in overseeing third-party providers (vendors) against contractual obligations
• Experience in explaining complex ideas in an appropriate format for academic and non-academic groups
• Experience in working independently, making independent decisions and working to and meeting firm deadlines
• Excellent verbal and written communication skills, particularly in the context of scientific writing, and reports and good telephone manners
• Experience in research in primary care
• Formal qualification in clinical trials (or working towards one) or post-graduate qualification in Clinical Trials or relevant field
• Understanding of NHS research structure and organisation
• Knowledge of electronic data capture systems for clinical trials
• Experience in the field of study of the trial

Qualifications: BA in Biology with 11 years of Experience

• Extensive knowledge of clinical research
• Understanding of the drug development process
• Knowledgeable about the critical elements for success in clinical trials, participation in and contribution to these activities
• Ability to review protocols, and programs, and assess the success of a project
• Strong understanding and knowledge of budgeting, forecasting, and resource utilization
• Mature management skills demonstrated by a calm and thorough review of situations. 
• Demonstrated leadership skills - successfully managed large project teams
• Strong communication and presentation skills - Demonstrates strong written and verbal communication skills
• Ability to establish and maintain positive Sponsor, project team member and internal relationships
• Computer skills with the ability to use clinical trial management systems, clinical trial databases, and electronic data capture
• Resourceful with heightened analytical abilities and problem-solving skills in a fast-paced environment
• Ability to independently manage projects in culturally diverse settings 
• Knowledge of different cultural sensitivities within regions and/or countries that could impact the progress of a clinical trial, and an ability to use that knowledge to manage relationships and share that knowledge with the larger project team

Qualifications: BA in Biomedical Science with 12 years of Experience

• Knowledge of Regulatory Sciences as demonstrated through a combination of work experience and academic background.
• Prior professional Clinical Trials Submissions and Operations experience in pharma, biotech or related industry.
• Prior experience with regulatory submissions and interactions with the FDA and other regulatory agencies.
• Prior project management experience with a certification
• Working experience in a consulting environment
• Strong attention to detail with solid organization/multitasking skills
• Excellent project management (research, planning, scheduling, documentation, project control), teamwork, and communication skills.
• A relationship builder with colleagues, prospects, clients, and regulatory authorities.
• Business Development skills by partnering on proposals, identifying opportunities, and networking
• Ability to work under deadlines to meet project timelines, including the ability to modify work schedules when needed.
• Computer skills including Windows, MS Office (Outlook, Word, Excel, PowerPoint, SharePoint) and Adobe Acrobat.
• A good working knowledge of Clinical Trial Management System

Qualifications: BA in Public Health with 8 years of Experience

• ICH-GCP and FDA regulatory requirement understanding and competency.
• Strong clinical study management skills, including risk assessment and contingency planning.
• Ability to approach assigned duties in a highly organized, detailed and accurate manner.
• Ability to manage multiple priorities and work in a flexible, dynamic, and fast-paced environment.
• Excellent oral/written communication, organizational, problem solving and conflict resolution skills.
• Willingness to travel as dictated by assigned project requirements
• Ability to work cross-functionally with other departments involved in the conduct of a clinical study.
• Ability (experience) to work with cross-cultural teams including personnel from global locations as required per project with a positive attitude.
• Microsoft Project, Office, PowerPoint, and Excel proficiency.
• Problem-solving abilities and a self-starter with a professional and courteous work demeanor. 
• Good consulting skills including influencing, advising, facilitating, diplomacy, critical thinking, adaptability, and presenting.

Qualifications: BA in Nursing with 7 years of Experience

• Proven understanding and experience working in clinical development
• Demonstrate evidence of a period of successfully managing and/or leading individuals/team
• Experience using project management software
• Solid understanding of how to craft and manage a project budget
• Knowledge of the key principles of cross-functional project management (Time, Quality, Cost) with solid financial acumen
• Displays effective communication skills (listening, oral, written) and can communicate in the English language (oral and written)
• Sound interpersonal skills, is flexible and adapts to changing situations
• The ability to persuade, convince, and influence or impress others
• Be organized, proficient at multi-tasking with good attention to detail
• Able to lead, motivate and coordinate teams, and coach/mentor team members

Qualifications: BA in Healthcare Administration with 6 years of Experience

• Experience with leading, liaising and coordinating cross-functional project teams
• Knowledge/understanding of clinical development guidelines and Directives
• Able to delegate, effectively prioritizes own and workload of project team members
• Ability to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc
• Possesses cross-cultural awareness and can adapt appropriately
• An understanding and appreciation of clinical research/development, including medical and therapeutic areas, phases and medical terminology
• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner
• Able to work upright and stationary for typical working hours
• Ability to use and learn standard office equipment and technology with proficiency
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities

Qualifications: BA in Biomedical Science with 9 years of Experience

• Clinical research experience within a pharmaceutical, biotechnology, or CRO setting.
• Experience as a clinical trial monitor, initiating, monitoring, and closing out clinical trials 
• Understanding of cross-functional processes including clinical operations, statistics, data management, subject randomization and drug supply management, data monitoring and adjudication committees, regulatory affairs, and medical writing.
• Knowledge and understanding of ICH guidelines, FDA, Health Canada, and EMA regulations.
• Demonstrated leadership abilities, including setting goals for others and driving to achieve them following allocated resources, timelines, and budgets.
• Ability to define scopes and estimate budgets, plan and manage projects, including resource requirements and utilization, hours spent vs. budgets, key deliverables, and timelines.
• Excellent interpersonal, oral, and written communication skills. 
• Demonstrate strong negotiation and presentation skills.
• Strong ability in problem-solving including conflict resolution.
• Fluency in French, including medical and scientific terminology

Qualifications: BA in Psychology with 10 years of Experience