Clinical Operations

• Provide cross-team administrative support to ensure continuity of operational activities during peak demand and absences.
• Maintain and update central systems (e.g. CTMS, booking systems, trackers) to ensure data accuracy and integrity.
• Coordinate and manage operational trackers, logs, and study documentation.
• Monitor workflows, identify discrepancies or issues, and take appropriate corrective or escalation action.
• Support standardisation of administrative processes across Clinical Operations teams.
• Contribute to reporting, metrics tracking, and performance monitoring across studies and services.
• Provide flexible administrative support across Clinical Operations teams, adapting to changing priorities and business needs.
• Maintain and update study trackers, logs, and administrative systems to ensure accurate reporting and oversight.
• Support scheduling, coordination, and resourcing of operational activities where required.
• Assist with coordination of study activities, including documentation, site communications, and reporting.
• Participate in team and project meetings as required.
• Coordinate communications between internal teams, external partners, and clinical sites.
• Maintain shared inboxes and ensure timely and professional responses to queries.
• Ensure accurate data entry, validation, and reconciliation across systems (e.g. duplicate checks, data quality checks).
• Monitor system performance and identify issues impacting workflows or service delivery.
• Generate and analyse reports to identify trends, risks, or areas for improvement.
• Support the setup, maintenance, and archiving of study documentation and databases.
• Ensure all activities comply with organisational SOPs, regulatory requirements, and data protection standards (e.g. GDPR, ICH GCP).
• Conduct routine quality checks on documentation, trackers, and systems to ensure completeness and accuracy.
• Support audit preparation, documentation collation, and follow-up actions.
• Identify and escalate risks, issues, or non-conformances within agreed timelines.

Clinical Operations Administrator

• Designing, planning, coordinating, and conducting activities for clinical research studies
• Acting as the primary contact for assigned study site personnel
• Performing site assessments and qualification visits
• Developing and managing key study site documentation
• Participating in and overseeing CRO delivery of site management activities
• Validating product performance claims
• Executing site management activities for sponsored studies
• Working in local and global study teams

Clinical Site Manager, Core Lab – Cardiovascular & Metabolic Diseases

• Design, plan, coordinate, and conduct clinical research studies across assigned sites.
• Act as the primary contact and clinical trial expert for assigned study site personnel, delivering technical assistance and coordinating necessary training.
• Perform comprehensive site assessments and qualification visits to drive informed site selection decisions.
• Collaborate cross-functionally to ensure investigational sites properly obtain and maintain institutional approvals and meet all regulatory compliance needs before trial initiation.
• Author and review key study site documents, including Study Monitoring Plans, informed consent forms, and case report forms.
• Execute all data generation, data validation, and comprehensive site visits across all study phases, from start-up through to close-out.
• Work dynamically within local, global, and virtual study teams, collaborating with R&D, Field Service, Study Management, and Biometrics to deliver top-tier solutions.

Clinical Site Manager, Molecular Lab

• Designing, planning, coordinating, and conducting clinical research studies
• Acting as the primary contact for assigned study site personnel
• Performing site assessments and qualification visits
• Developing and managing key study site documentation
• Overseeing CROs for site management activities
• Executing site management activities for studies across all phases

Clinical Site Manager – Near Patient Point of Care, Cardiovascular & Metabolic Diseases

• Designing, planning, coordinating, and conducting all activities involved in initiating, monitoring, and completing clinical research studies at assigned sites.
• Leading end-to-end study start-up activities, driving site selection, activation, and qualification assessments to ensure clinical trials launch efficiently and are compliance-ready.
• Managing Ethics Committee (EC) and Competent Authority (CA) submissions, ensuring all trial documentation is available, local contracts, and approvals meet stringent regulatory requirements.
• Providing robust CRO oversight, monitoring external partner deliverables, tracking milestones, and escalation of any issues.
• Acting as the primary contact and clinical trial expert for assigned study site personnel, for execution of the study - including training and coordinating certification of study site personnel.
• Developing critical study documentation, including informed consent documents, patient instruction guides, and key documents for EC/CA submissions.
• Collaborating cross-functionally with global, local, and virtual teams, demonstrating diversity, cultural awareness, and fostering strong, collaborative relationships with cross-functional team members, internal stakeholders, and external partners to achieve business goals.

Clinical Site Manager – Study Start Up, In Vitro Diagnostic Regulation

• Lead end-to-end study start-up activities
• Manage Ethics Committee (EC) and Competent Authority (CA) submissions
• Provide robust CRO oversight
• Act as the primary contact and clinical trial expert
• Develop critical study documentation

Lead Clinical Site Manager – Study Start Up, In Vitro Diagnostic Regulation

• **Key Elements and Responsibilities**
• · Provide strategic and operational leadership for clinical operations and data management across programs, from study start-up through close-out, in compliance with ICH-GCP.
• · Ensure the quality, integrity, and inspection-readiness of all clinical and data management activities globally.
• · Drive cross-functional collaboration to deliver clinical trials on time and within budget.
• · Lead planning, execution, and reporting of clinical studies, ensuring alignment on timelines, deliverables, and resources.
• · Act as the primary escalation point for critical study and vendor issues.
• · Oversee study budgets, timelines, resources, and financial tracking.
• · Partner with Clinical Science, Biostatistics, and external vendors to ensure seamless delivery of:
• o Clinical documentation
• o Data management activities
• · Ensure effective coordination of regulatory submissions (e.g., IRB/ethics committees, local authorities).
• · Oversee data management strategy and execution, including database design, build, maintenance, and database lock activities, in alignment with biostatistics.
• · Ensure robust data integrity, accurate record-keeping, and compliant archiving practices.
• · Provide oversight of clinical sites, academic partners, and vendors (e.g., CROs, labs) to ensure performance, quality, and compliance.
• · Build and maintain strong relationships with investigators and key opinion leaders.
• · Lead, develop, and mentor high-performing teams.
• · Ensure delivery of high-quality study documentation to meet program timelines.

VP, Clinical Operations, Data Management

• Support activities related to study/site feasibility, start-up, maintenance, and close-out
• Manage study and site essential document review, collection, tracking, etc. from study start-up through maintenance and close-out
• With guidance, support the Study Lead (CTM, AD, etc.) to prepare and maintain study documents and manuals as applicable
• Study Trial Master File oversight, review and filing
• Organise study related meetings including but not limited to preparation of agenda/ minute taking and maintenance of risk/ issue/ decision logs
• May perform applicable site monitoring / co-monitoring visits (ad hoc, pre-study, initiation, routine monitoring close-out visits)
• Provides rapid action to address both internal and site QA findings from audits
• May manage, coordinate, and oversee the activities from third party vendors including deliverables metrics, accruals, process planning, and implementation
• General study tracking and maintenance and study site oversight including but not limited to site performance, metrics, monitoring report review, etc.
• Assist and support study data related activities including data review, query creation and resolution, study and protocol deviation reviews, safety reviews, etc.
• Routinely support and participate in department and clinical trial team meetings and participate in collaborative efforts (e.g., protocol development, CRO selection, departmental initiatives, etc.)
• Review and verification of contracted vendor activities including vendor invoice review

Associate Clinical Operations Leader – Clinical Trial Specialist

• Plan, direct, create, and communicate clinical study timelines to ensure deliverables are produced on schedule
• Gather input from cross-functional teams to create comprehensive plans for clinical studies
• Ensure consistency of clinical study processes across clinical trials, adhering to standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations
• Oversee and resolve operational aspects of clinical trials in conjunction with project teams
• Select sites and vendors, prepare clinical trial budgets, and ensure studies are conducted within clinical trial protocols
• Monitor progress and follow up with team members and line managers when issues develop
• Implement and prepare the clinical development strategy as outlined by the clinical teams
• Develop trial recruitment strategies to ensure successful participant enrollment

Single Sponsor Clinical Project Manager II, Virology

• Responsible for leading and coordinating project activities, ensuring that projects are delivered on time, within budget, and to the highest quality standards.
• Focus on coordinating project and programme management delivery, resolving issues, and developing team capability.
• Applies thorough knowledge of GCP/regulatory requirements to all aspect study preparation and oversight.
• Prepares all external and internal documentation for assigned trials ensuring it is completed in accordance with internal SOP’s and GCP requirements (e.g., Patient Informed Consent Forms, Monitoring Plans, Project Plans) and consistent with the study protocol.
• Develops and maintains study timelines for assigned studies with some supervision.
• Contributes to timelines in appropriate areas for larger teams.
• Oversees monitoring activities and conducts monitoring visits and co-monitors as needed.
• Directly oversees the clinical sites, vendor(s), and study team on assigned studies to ensure consistency of methods, interpretation and approach of assigned studies.
• Conducts training regarding logistics of the clinical trial including protocol, coordinating trial materials.
• Oversees all aspects of the Trial Master File (TMF).
• Responsible for organizing and preparing study files for more complex studies, and oversees the preparation and submission to archives of other study files.

Global Clinical Project Manager

• Lead our UK & EU Clinical Operations team
• Responsible for our portfolio of trials and scaling our UK & EU operations
• Use AI tools to reshape and improve clinical operations, trial oversight and trial delivery
• Input on the roadmap and features of our proprietary trial technology platform, Citrus
• Oversee the UK & EU Clinical Operations team, ensuring that trials are delivered successfully (on time, on budget, in compliance, and of high quality)
• Create and maintain optimal working practices, SOPs, systems and tools for robust Study Management execution and stakeholder communications
• Work with Clinical Operations leadership to proactively solve issues
• Direct Project Support staff and mentor project management and clinical staff; facilitate team building and communication
• Implement resource strategies to achieve project goals
• Develop contingency planning and risk mitigation strategies
• Lead hiring and expansion of the UK & EU ClinOps team
• Develop and deliver team training reflective of current best practice
• Ensure seamless integration of our US Clinical Operations team

VP of ClinOps

• Serve as the primary medical writing lead for one or more clinical programs.
• Provide day-to-day leadership for medical writing activities across assigned programs.
• Shape and maintain writing standards, templates, and best practices to ensure consistency and quality.
• Provide expert guidance to cross functional teams on document expectations, structure, and delivery timelines.
• Lead and/or author high-quality clinical documents, including Protocols & amendments, Clinical Study Reports (CSRs), Investigator’s Brochures (IBs).
• Support Regulatory consultations & submissions (e.g. INDs, FDA/EMA/PMDA briefing documents).
• Partner closely with Clinical Development, Biostatistics, Data Management, Regulatory Affairs, and all stakeholders to ensure smooth and timely documentation delivery.

Medical Writing Lead, Global Clinical Operations

• Manage vendor activities across the study lifecycle
• Oversee vendor deliverables during study initiation
• Track vendor performance, identify risks, and escalate issues
• Drive vendor activities to support site activations
• Coordinate vendor deliverables that support Database Lock and study closure

Global Clinical Project Manager – Vendor Management Expert

• Provides input to the overall operational trial(s) implementation, manages trial(s) timelines, budget, feasibility, country identification and sites selection, enhanced patient recruitment, and functions as the primary liaison for internal stakeholders and vendors.
• Accountable to deliver Trial(s) on time, within budget, and with highest achievable quality.
• Assist in the review, development and/or writing of clinical trial documents and manuals, including but not limited to Protocol, Case Report Forms, informed consent forms, Clinical Study Report and other regulatory documents.
• Lead the evaluation and selection of investigative sites; responsible for feasibility.
• Select, coordinate and monitor activities of vendors Review of monitoring reports and conduct co-monitoring visits, as needed.
• Develop and manage trial(s) timelines, budget and priorities.
• Participate in data review and discrepancy resolution.
• Ensure set up and maintain all systems in order to plan and implement trial(s) and track progress.
• Generate reports to update management on conduct of trial.
• Ensure appropriate clinical trial supply plans are implemented and managed.
• Develop recruitment plans, risk-mitigation plan, monitor, and implement contingencies as required.
• Participate in monitoring study safety.
• Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team.
• Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work.
• Assist with CRA and third party vendor training on protocols and practices.
• Lead the multi-disciplinary trials teams; include the study team meetings.
• Function as the primary contact for trial(s) between Drug Development and other departments.
• Assume responsibility to participate as a member of working groups and perform special projects, as assigned.
• Ensure adherence to Good Clinical Practice and all applicable local and international regulations.

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