Parexel

IT Support

• Independently plan, conduct, and report on audits across all clinical research phases, including project audits, system audits, supplier qualifications, TMF audits, and pharmacovigilance audits
• Complete high-quality audit reports within timelines and budgets, including complex for-cause and co-audits with clients
• Support Serious Breach investigations, provide regulatory guidance on GxP requirements, and facilitate client audits and regulatory inspections
• Review CAPA responses, escalate delays, and consult with Operations and Quality teams on implementation
• Help develop and improve Parexel procedures, systems, and audit strategies

Audit Specialist – Sponsor Audits and Inspections

Analyst

• Work closely with project teams and other internal departments, including but not limited to SSU/Site Contracts, Accounts Payable and Accounts Receivable / Billing.
• Participate as a representative of the Investigator Payment team in study start-up meetings.
• Review and understand budget details within sponsor and site contracts to assist with fund setup requirements.
• Create and review metrics on fund setup productivity and helpdesk inquiries and provide reporting to management team.
• Assist with performing periodic quality control reviews on completed fund setup requests.
• Provide support to the Investigator Payments and Analytical teams.

Site Budget Setup Analyst I

Consultant

• Building and maintaining relationships with clients
• Providing technical leadership and training to junior staff
• Generating and advocating thought leadership pieces
• Leading the delivery of projects on time and to a high quality
• Writing and presenting proposals to prospective clients
• Driving sales targets and NBA's
• Providing advanced methodological and modelling leadership on complex projects
• Acting as Project Director on key engagements, assuring quality, timelines and financial performance
• Supporting account and client relationship management and contributing meaningfully to new business activities, driving business growth
• Taking a visible role in developing people, methods, and internal standards

Principal Consultant, Health Economics, Modelling

Research Analyst

• Conduct clinical trials
• Collaborate with healthcare professionals
• Ensure compliance with regulations
• Analyze data and report findings

Clinical Research Associate

Translator

• Lead critical translational insights to accelerate clients' pipelines
• Provide scientific leadership, drug development guidance, and consulting support to clients
• Shape and execute precision medicine clinical studies across therapeutic areas
• Collaborate with cross-functional teams and external clients/partners

Director – Translational Medicine

Clinical Research

• The Study Operations Manager I (SOM I) has responsibilities for study and regional or specific country level activities from study startup through conduct and study close on one or more studies, providing leadership, strategic planning, and organization skills to ensure the operational delivery of tasks.
• Supports Global Study Managers (GSMs), other SOMs, and the larger study management delivery of the study by leading specific parts of the project, driving specific countries, executing tasks of moderate complexity, and developing solutions to problems as needed to support deliverables
• Serves as leader of the local study team (core members, ad hoc members, and other key stakeholders as required) on one or more studies
• Oversees the preferred Contract Research Organization (pCRO) and/or Country Trial Manager (CTM)/Site Care Partner (SCP) for assigned studies at country level in accordance with the overall project plan, and manages and maintains accurate country level plans (e.g., timelines, budget, risk, and quality plans)
• May manage the study start-up process in countries assigned [where the Start Up Project Manager (SUPM) is not assigned] and/or oversee the pCRO responsible for these activities as applicable
• Liaises with SCP, Lead SCP, Site Activation Partners (SAPs), and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethic Committees (ECs)
• Provides country level input on startup and recruitment milestones as provided by pCRO and/or CTM/SCP to GSM during planning
• Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required.
• Accountable for resolution of site activation escalations to study teams including offering options for mitigation
• May be responsible and accountable for, as designated by the GSM: Regional, country and study level recruitment strategy
• Communication with the local team and internal stakeholders and pCRO as applicable to ensure efficient and timely study delivery of the agreed plans
• Study and/or country vendor management and oversight including follow up and coordination of vendor deliverables
• Assurance of the follow up and coordination of regional and site quality events, protocol deviations, data issues, metrics review, site issues and risks, audit responses, etc.
• Acts as the point of contact for all study level questions for the local study team, ensuring resolution at lowest possible level, and when needed liaising with and escalating to appropriate global roles and teams
• May lead operational effectiveness initiatives at country or regional level
• Utilizes roles in country such as Lead SCP, and expert roles such as Contracts Leads and SAPs, to provide the global teams with local intelligence and operational nuances to be considered
• Provides input on country level per subject costs, local vendor costs, and other fees where applicable
• Utilizes country intelligence to provide input on country specific risks into preparation of Investigational Quality Management Plan and Study Monitoring Plan, and ensures Trial Master File (TMF) completeness and oversight of all relevant compliance activities for allocated studies
• Supports implementation of client’s site technology experience systems
• Supports implementation of new tools and technologies (e.g., eConsent, eISF, remote source access, remote source data verification/review (SDV/SDR), iConnect, implementation of protocol required decentralized trial options)

Country Study Operations Manager – Clinical Trial Manager

Operations

• Supports Global Study Managers (GSMs), other SOMs, and the larger study management delivery of the study by leading specific parts of the project, driving specific countries, executing tasks of moderate complexity, and developing solutions to problems as needed to support deliverables
• Serves as leader of the local study team (core members, ad hoc members, and other key stakeholders as required) on one or more studies
• Oversees the preferred Contract Research Organization (pCRO) and/or Country Trial Manager (CTM)/Site Care Partner (SCP) for assigned studies at country level in accordance with the overall project plan, and manages and maintains accurate country level plans (e.g., timelines, budget, risk, and quality plans)
• May manage the study start up process in countries assigned [where the Start Up Project Manager (SUPM) is not assigned] and/or oversee the pCRO responsible for these activities as applicable
• Liaises with SCP, Lead SCP, Site Activation Partners (SAPs), and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethic Committees (ECs)

Country Study Operations Manager I

Data Engineer

• Implement and manage data solutions on Azure
• Create and maintain data pipelines, storage solutions, and data transformation
• Design, build, modify, and support data pipelines leveraging DataBricks and PowerBI
• Collaborate with Team Leads to define/clarify business requirements

Senior Azure Data Engineer

• Responsibilities for study and regional or specific country level activities from study startup through conduct and study close on one or more studies
• Provides leadership, strategic planning, and organization skills to ensure the operational delivery of tasks
• Serves as leader of the local study team on one or more studies
• Provides back up to or assumes the responsibilities of the GSM as needed
• Oversees the preferred Contract Research Organization and/or Country Trial Manager/Site Care Partner for assigned studies at country level
• Manages and maintains accurate country level plans (e.g., timelines, budget, risk, and quality plans)
• Manages the study startup process in countries assigned or oversees the CRO responsible for these activities
• Liaises with SCP, Lead SCP, Site Activation Partners and regulatory colleagues in country to agree on submission strategy to Health Authorities and Ethics Committees
• Provides country level input on startup and recruitment milestones during planning
• Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required.

Study Operations Manager – Clinical Trial Manager

Clinical Operations

• Manages country deliverables, timelines, and results for assigned protocols to meet country commitments
• Coordinates and liaises with Clinical Research Managers, Clinical Research Associates and Clinical Trial Coordinators, Finance and Legal if appropriate to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones
• Collaborates closely with Headquarter to align country timelines for assigned protocols
• Provides support and oversight to local vendors as applicable
• Oversees CTCs as applicable
• Contributes to the development of local SOPs
• Oversees and coordinates local processes, clinical and ancillary supplies, import and export requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management
• Enters and updates country information in clinical and finance systems
• Contributes or leads initiatives and projects adding value to the business
• Acts as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement, and providing training as appropriate/ required
• Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training
• Adheres to EP and Client SOPs and processes
• Has ownership of country and site budgets including development, negotiation, and completion of Clinical Trial Research Agreements (CTRA)
• Oversight and tracking of clinical research - related payments
• Payment reconciliation at study close - out
• Oversight of Foreign Corrupt Practices Act (FCPA), Denied Party Screening/Office of Foreign Assets Control (DPS/OFAC) and maintenance of financial systems
• Financial forecasting in conjunction with SCOM, CRD and other roles
• Influences investigators, external partners, and country operations to adhere to budget targets and agreed payment timelines.
• Executes and oversees clinical trial country submissions and approvals for assigned protocols

Clinical Operations Manager – FSP

Software Engineer

• Design, build, test, document, deploy, and support Extend & integration solutions for Workday.
• Ability to help resolve integration issues requiring in depth expertise of Workday products.
• Demonstrated integration experience in Human Resources, Payroll or Financials Management.
• Maintain an understanding of the application landscape and support maintaining documentation about all applications in the architecture repository.

Workday Extend Developer

Medical Director

• Initiate and maintain medical and consultative relationships with clients
• Independently deliver all medical support required for successful delivery of the projects
• Provide training of study teams on TA indication and protocol
• Deliver medical monitoring activities according to MMP during the study conduct
• Actively listen to, solicit and address client feedback and suggestions regarding medical study-related activities
• Support Business Development as a core priority while adequately balancing time with billable tasks
• Work with Section Head to develop expertise in therapeutic area; provide medical expertise/leadership in multiple channels and interactions
• Create a culture of continuous improvement and lead team through change

Senior Medical Director – Therapeutic Area Lead, Women's Health

Manager

• Responsible for driving global study start-up and site activation activities, milestone oversight, and CRO delivery.
• Develop and deliver the global study startup plan by partnering with the CRO Study Startup team.
• Lead development of procedures to enhance internal start-up capabilities and drive efficiencies to align with Trial Delivery Optimization goals.
• Guide study teams through conduct and delivery of key startup activities within timelines that contribute to operational planning/decisions resulting in predictable delivery for achieving R&D goals.
• Oversee the analysis of clinical trial data and its application to conduct accurate study startup forecasts.
• Collaborate with internal Feasibility experts to drive rapid, accurate, and data-driven study startup forecasts, benchmarking assumptions, scenarios and accurate planning.
• Develop creative processes, methodologies, data and technologies to ensure ongoing delivery of valued Study Startup Services.
• Participate in early, global, strategic study planning to ensure corporate goals and timelines for study start-up and site activation are accurate and achievable; ensure CRO commitment to all study deliverables and timelines.
• Partner with CRO to ensure efficient start-up processes and reporting to deliver best in practice country and site activations.
• Work directly with internal study team members and CRO counterparts to progress site activations efficiently and as per targeted milestones; facilitates timely resolution of site-level issues by utilizing in-country intel and expertise to remove or prevent roadblocks
• Tracks and reports relevant KPIs and metrics including local country and site level cycle times to support process improvement and overall operational/business reporting to accelerate site activation
• Oversee consistent application of appropriate study start-up standards and processes to deliver high quality, cost effective clinical studies in line with local operational, legal and regulatory requirements
• Build and maintain study start-up, country and site activation best practices.
• Support the recruitment and performance of junior staff; provide guidance for effective prioritization, problem identification and solving resulting in improved strategic drug development operational efficiency.

Senior Manager, Study Start Up – FSP

• Responsible for driving global study start-up and site activation activities, milestone oversight, and CRO delivery.
• Develop and deliver the global study startup plan by partnering with the CRO Study Startup team.
• Drive efficiencies to enhance internal start-up capabilities to align with Trial Delivery Optimization goals.
• Guide study teams through conduct and delivery of key startup activities within timelines that contribute to operational planning/decisions resulting in predictable delivery for achieving R&D goals.
• Collaborate with internal Feasibility experts to drive rapid, accurate, and data-driven study startup forecasts, benchmarking assumptions, scenarios and accurate planning.
• Participate in early, global, strategic study planning to ensure corporate goals and timelines for study start-up and site activation are accurate and achievable; ensure CRO commitment to all study deliverables and timelines.
• Partner with CRO to ensure efficient start-up processes and reporting to deliver best in practice country and site activations.
• Work directly with internal study team members and CRO counterparts to progress site activations efficiently and as per targeted milestones; facilitates timely resolution of site-level issues by utilizing in-country intel and expertise to remove or prevent roadblocks.
• Tracks and reports relevant KPIs and metrics including local country and site level cycle times to support process improvement and overall operational/business reporting to accelerate site activation.
• Oversee consistent application of appropriate study start-up standards and processes to deliver high quality, cost effective clinical studies in line with local operational, legal and regulatory requirements.
• Build and maintain study start-up, country and site activation best practices.
• Support inspection/audit readiness by ensuring compliance with GCP, SOPs, and regulatory requirements.
• Contribute to continuous improvement initiatives, tool/technology adoption, and knowledge sharing to enhance study start-up efficiency.

Manager, Study Start Up – FSP

Supply Chain

• Provide tactical sourcing solutions for depot, investigation medicinal product, courier, and ancillary supplies
• Analyze and understand complex customer requirements
• Provide professional advice and ongoing support to meet study requirements
• Play a leading role in supplier management
• Initiate and develop advanced sourcing ideas
• Share knowledge and mentor junior team members