Celerion

Medical writer

• Analyze and interpret all types of medical results including, but not limited to the following: vital signs, clinical laboratory values, adverse events, electrocardiograms (ECGs), diagnostic procedures, and various pharmacodynamic (PD) endpoints.
• Compile and write Phase I and Phase II clinical trial documents including, but not limited to the following: clinical study reports (CSRs), stand-alone safety narratives, and synoptic CSRs.
• Review/evaluate study results to determine whether or not the safety objectives and/or endpoints were met, accurately reflecting the results in the safety text.
• Perform peer QC function of safety text prior to inclusion in the CSR.
• Review reports for completeness and accuracy assuring that the safety text fits into the CSR as whole and recommending changes or rewriting, as appropriate.
• As the project Report Lead on a multi-disciplinary scientific team, ensure quality and on-time delivery of scientific reports.
• Monitor content of editorial comments received prior to incorporation into the report to assure report text comments are accurate and support the objectives and/or endpoints.
• Assure deliverables are compliant with applicable regulatory standards (i.e. Good Clinical Practice, International Conference on Harmonisation guidelines) and client specifications.
• Use technology to work with international teams (e.g., WebEx™,Veeva, Microsoft® 365 applications, SharePoint®, and SmartSheet).
• Lead-Project-related client communication.
• Interact with internal departments (e.g. data management, project management, business development, etc.).
• Participate in functions required to ensure success of department and/or market segment team.

Medical Writer

Clinical Research

• Support Program Directors and, at times, Global Project Managers with project and administrative functions under their direction to ensure on-time project execution and compliance.
• Assist with study preparations, study maintenance, and closeout activities.
• Create high-quality meeting minutes and documentation.

Project Coordinator – Clinical Research

Director

• Lead the global strategy, governance, and continuous improvement of end-user IT support services.
• Ensure a consistent, high-quality support experience for employees across all Celerion locations.
• Define service delivery standards focused on responsiveness, quality, customer satisfaction, and operational excellence.
• Drive initiatives that improve employee productivity through technology enablement.
• Develop trusted relationships with business leaders to understand operational priorities and evolving technology support needs.
• Act as the voice of the business within IT for all user support services.
• Translate business requirements into actionable service expectations for internal teams and external partners.
• Communicate service capabilities, processes, and performance metrics to stakeholders.
• Serve as the primary operational relationship manager for outsourced service providers supporting end-user technologies.
• Monitor vendor performance against contractual obligations, SLAs, KPIs, and customer experience objectives.
• Conduct regular operational reviews and business reviews with strategic partners.
• Escalate and resolve performance issues while driving accountability and continuous improvement.
• Partner with Procurement and IT leadership during contract renewals, service expansions, and vendor evaluations.
• Oversee global service desk operations, desktop support, executive support, field services, and endpoint lifecycle management.
• Ensure effective incident, request, problem, and knowledge management processes are followed.
• Promote ITIL-based best practices to improve service quality and operational efficiency.
• Drive automation and self-service initiatives to improve user experience.
• Champion a customer-first culture throughout IT support operations.
• Establish and monitor user satisfaction metrics, including CSAT and service quality trends.
• Identify opportunities to simplify support processes and reduce recurring issues.
• Lead initiatives that improve the overall digital workplace experience.
• Analyze service metrics and operational trends to identify improvement opportunities.
• Implement process improvements that increase efficiency, reduce support costs, and enhance service quality.
• Partner with infrastructure, security, application, and business teams to proactively resolve systemic issues.
• Lead organizational change related to user support technologies and service delivery.
• Mentor and develop internal IT service management staff.
• Foster collaboration between internal teams and external partners.
• Build a culture of accountability, customer service, innovation, and continuous improvement.
• Support strategic IT initiatives and organizational transformation efforts.

Director, User Services

Vice President

• Responsible for defining and executing the enterprise technology strategy for Celerion.
• Oversee infrastructure, cybersecurity, enterprise applications, digital transformation, data platforms, laboratory systems, and regulated technology operations supporting Celerion’s global operations.
• Partner closely with executive leadership, operations, quality, regulatory, and business development teams to ensure technology capabilities enable operational excellence, regulatory compliance, scalability, innovation, and exceptional client experiences across all global sites.
• Develop and execute a multi-year global technology roadmap aligned with corporate objectives and growth strategy.
• Lead enterprise-wide digital transformation initiatives supporting clinical, laboratory, and business operations.
• Advise executive leadership on emerging technologies, cybersecurity risks, AI opportunities, automation, and data modernization.
• Build strong relationships with operational leaders to ensure technology solutions improve efficiency, quality, and customer experience.
• Establish technology governance, architectural standards, and investment prioritization processes.
• Oversee global IT infrastructure including cloud platforms, data centers, networks, endpoint management, collaboration tools, and telecommunications.
• Ensure high availability, disaster recovery, business continuity, and operational resilience across global locations.
• Lead modernization of legacy systems while minimizing operational disruption.
• Direct global service desk and support operations with measurable SLAs and customer satisfaction metrics.
• Responsible for cybersecurity strategy, risk management, incident response, and security operations.
• Ensure compliance with GxP, FDA, GDPR, SOC, ISO, and other applicable regulatory frameworks.
• Partner with Quality and Regulatory teams to support computerized system validation and maintain audit readiness.
• Oversee security awareness, vulnerability management, identity management, and third-party risk programs.
• Drive enterprise data strategy including governance, analytics, reporting, and AI-enabled insights.
• Ability to manage infrastructure and optimize operational efficiency while balancing innovation, risk and cost management.
• Lead evaluation and implementation of scalable technology platforms supporting global expansion.
• Manage global technology budgets, forecasting, contracts, and software licensing.
• Negotiate strategic vendor relationships and technology partnerships.
• Establish KPIs and reporting mechanisms to measure technology performance and value realization.
• Build and lead a high-performing global technology organization.
• Foster a culture of accountability, innovation, collaboration, and continuous improvement.
• Lead geographically distributed teams across multiple time zones and business functions.
• Drive the identification, incubation, and commercialization of AI capabilities that strengthen competitive positioning, accelerate growth opportunities, and enhance enterprise value.

Vice President – Global Technology

Business Operations

• Act as the central point of contact for DMB activities across research projects.
• Ensure deliverables are met and clients are satisfied.
• Collaborate with scientific professionals, including Biostatisticians, Pharmacokineticists, Data Analysts, and Medical Writers.
• Coordinate with GPMs and functional managers to assign and prioritize work based on project and team needs.
• Coach and support DMB team members to ensure successful project outcomes.
• Manage multiple DMB projects, ensuring timelines and deliverables are met.
• Lead regular team meetings to maintain engagement and alignment with client expectations.
• Monitor project progress and proactively address risks.

Business Operations Manager – Scientific Department

Designer

• Responsible for the logistical set up and maintenance of clinical trials in ClinQuick - our electronic data capture system.
• Manage the creation of study conduct instruction manuals and detailed timed event schedules for the clinic staff and study participants.

Clinical Study Designer

Research Analyst

• Oversee monitoring and site management activities for clinical trials, clinical investigations and other interventional or non-interventional studies.
• Provide experienced leadership to a team of Clinical Research Associates involved in clinical studies executed at the sites.
• Direct supervision/line management of CRA staff and contractors in accordance with Celerion policies and applicable regulations.
• Interview, hire, and conduct onboarding training for new staff.
• Prepare and implement function-specific training programs and ensure adherence to Celerion’s procedures and guidance documents.
• Assign staff members to clinical projects and monitor staff workload.
• Ensure timely submission of timesheets and expense reports by staff.
• Develop, mentor, manage and coach CRA staff to progress their skills.
• Perform annual appraisals, define performance objectives and advocate individual career development.
• Serve as escalation line for direct reports including troubleshooting and issue escalation.
• Generate action plans and provide oversight to optimize monitoring services.
• Maintain a positive, results-oriented work environment and model teamwork.
• Support day-to-day execution of monitoring services for ongoing projects.
• Ensure deliverables of the CRAs assigned to the projects are met on time within quality and budget parameters.
• Interact with Sponsor/Client and participate in Sponsor/Client meetings as necessary.
• Participate in audits and inspections, including preparation activities.

Lead, Clinical Research Associate

Software Engineer

• Serve as a subject matter expert in Veeva Clinical Data Management Suite (CDMS), including Veeva Electronic Data Capture (EDC) and Veeva Clinical Database (CDB)
• Perform all activities related to eCRF design and EDC build programming for assigned projects
• Perform EDC edit check programming for assigned projects based on edit check specifications for both simple and complex edit checks
• Create test data to verify both screen design and edit check programming prior to deploying to User Acceptance Testing (UAT)
• Set up test environments and coordinate project team members for execution of test scripts
• Program and configure listings and reports using clinical reporting tools such as Veeva Clinical Database (CDB)
• Ensure secure and high-integrity database imports from vendor transfers using Celerion data transfer standards
• Assist with the validation of upgrades to hardware/ software including validation documentation development, review and execution.
• Maintain global clinical trial database standards (CDISC)

EDC Developer, Programmer

QA Engineer

• Carry out auditing of study, project, and process reports, records and data; report audit findings to operations via QA audit reports; and determine acceptability of the responses and verify the corrections (includes but not limited to Clinical Study Report audits, Protocol audits and Electronic Database Capture (EDC) audits).
• Interact with internal and external clients to discuss QA observations and study-related issues; and maintain effective and professional working relationships within and across departments in relation to study projects.
• Participate and lead in the improvement initiatives intended to improve quality, compliance of study, project data and reports; effectiveness and efficiency of the processes.
• Detect quality issues and the need for CAPAs and evaluate deviations
• Assist with the preparation for and hosting of client audits and/or regulatory inspections.
• Participate in the preparation, conduct and follow-up for System Audits and Vendor Audits

Quality Assurance Auditor

Clinical Operations

• Lead the initiation, maintenance and close out activities of multi-center studies in accordance with the protocol, relevant SOPs, Good Clinical Practice, international standards, and regulatory requirements
• Plan and procure team resources as needed to complete study activities according to scope, budget, and timeline
• Develop and/or oversee development of study plans such as project management (including communication), monitoring, risk management, data management and safety plans
• Coordinate activities with central laboratories and other external service providers/vendors
• Review and negotiate site budgets and contracts
• Initiate and participate in the development of change orders to sponsor and/or site contracts and budgets
• Maintain appropriate and effective communication with sponsor, external service providers, and other internal departments to ensure successful project completion

Clinical Project Manager

Project Manager

• Support day-to-day management of studies, ensure within the Study Team that project/study tasks are delivered in time, within the budget, and according to Sponsor/Client expectations, in close cooperation with designated Project Team
• Support the implementation and maintenance of studies; assist so that Sponsor and Investigator obligations are met and are in compliance with applicable regulatory requirements (including local law) as well as Good Clinical Practice
• Support in document management (creation, review, collection, filing, forwarding) including submission documents, meeting minutes and Trial Master Files, from Pre-study Phase to Study Closure
• Support (field) monitors by (but not limited to) preparing checklists, controlling completion status and timelines, updating relevant tracking sheets
• Create, review, finalize, forward and file meeting minutes for all internal and external study-related meetings.
• Support in Celerion process improvement
• Support in-house in performing site feasibility and site qualification visits in order to select qualified sites
• Support to prepare documents for Site Initiation Visits (SIVs), such as presentation slides
• Support to prepare documents for Monitoring Visits
• Support to prepare documents for Close-out Visits
• Perform content review and quality checks of received documents
• Cooperate with central TMF team to keep Trial Master File (TMF) up-to-date and track filed documents
• Support query resolution in a timely manner
• Support Serious Adverse Event (SAE) reporting according to study specifications
• Support in document/review study status, site enrolment status
• As a member of Celerion’s project teams, perform billable work in accordance with Celerion BCDs, SOPs and PGs, and within the relevant timelines
• Interact with Sponsor/Client and participate in Sponsor/Client meetings as necessary
• Participate and demonstrate proactive involvement in project/study meetings, internal project/study meetings, and other activities enhancing project progress
• Participate in audits and inspections, including preparation and follow-up activities
• Support Sponsor/Client in fulfilling their obligations with regard to submissions according to relevant regulatory requirements