Parexel

Software Engineer

• Provides technical expertise for the conduct of clinical trials and acts as an internal subject matter expert in specific areas
• Works independently to support various programming activities related to the analysis and reporting of clinical study data
• Can fill the Statistical Programming Lead role on projects and liaise with sponsors, Biostatistics Leads, Data Management Leads, and other functional areas as required
• Monitors quality, timelines, resource allocation, and productivity in relation to budgets
• Provides technical support and expert advice to internal and external sponsors
• Recognized as a subject matter expert and expected to mentor and lead global teams
• Supports programming activities related to the analysis and reporting of clinical study data and ensures adherence to SOPs and regulations

Senior / Principal Clinical SAS Statistical Programmer

Operations

• Oversees the 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
• 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.
• May be responsible and accountable for, as designated by the GSM: o Regional, country and study level implementation of startup and site activation plans (through SUPM or pCRO if assigned) o Regional, country and study level recruitment strategy o Support of the development of study level plans o Communication with the local team and internal stakeholders and pCRO as applicable to ensure efficient and timely study delivery of the agreed plans o Study and/or country vendor management and oversight including follow up and coordination of vendor deliverables o 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.
• 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) compliance with Parexel standards: • Complies with required training curriculum • Completes timesheets accurately as required • Submits expense reports as required • Updates CV as required • Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Country Study Operations Manager

• 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 on one or more studies
• Oversees the pCRO/CTM/SCP for assigned studies at country level in accordance with the overall project plan, and manages and maintains accurate country level plans (timelines, budget, risk, and quality plans)
• May manage the study start up process in countries 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 Ethics 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 for regional, country and study level implementation of startup and site activation plans, recruitment strategy, and study level plans
• Supports development of TMF set up and ensuring TMF completeness; maintains oversight of ISF reconciliation
• Supports identification, contract development and management of local vendors or facilities as per protocol
• Provides Investigator Meeting (IM) support and management
• Provides country level documents to TMF and maintains oversight of ISF reconciliation and completeness actions
• Supports submissions to ECs, Regulatory Authorities (RAs), and other relevant bodies within required timelines
• Ensures ICH GCP standards and Parexel SOPs compliance; manages quality events and data issues
• Drives data cleaning deliverables for pCRO and sites; coordinates site recruitment planning for country/site targets
• Maintains knowledge of Parexel processes and global/local regulatory requirements
• Supports implementation of client’s site technology experience systems

Country Study Operations Manager – FSP

Research Analyst

• Act as direct contact with assigned sites, assess and ensure integrity of study implementation and adherence to protocol at clinical sites
• Build relationships with investigators and site staff; facilitate access to relevant study systems and ensure training compliance
• Evaluate site recruitment plan; provide improvement strategy; determine corrective actions and follow-up
• Address and resolve issues at sites, including training gaps, documentation deficiencies, and site questions
• Conduct on-site visits (Qualification, Initiation) and remote visits; generate visit reports
• Monitor site compliance, performance, and personnel; assess test article supply and site payments
• Review and follow-up site documentation and regulatory documents; ensure TMF submission and file maintenance
• Ensure CTMS/EDC/SIS data entry quality; maintain site data quality in CTMS and regulatory readiness
• Ensure compliance with ICH-GCP and local regulations; coordinate audits and inspections as required
• Provide site-specific training; conduct facilities assessments
• Collaborate with team, management, and sites to meet trial milestones and timelines

Clinical Research Associate, FSP

• For every role, we look for professionals who have the determination and courage always to put patient well-being first. That to us is working with heart. Here are a few requirements specific to this advertised role.
• Skills Networking and relationship building skills.
• Ability to communicate effectively and appropriately with internal and external stakeholders.
• Ability to adapt to changing technologies and processes.
• Effectively overcoming barriers encountered during the implementation of new processes and systems.
• Excellent communication (verbal and written), presentation, and interpersonal skills relating to colleagues and associates, both inside and outside of the organization.
• Identifies and builds effective relationships with investigator site staff and other stakeholders.
• Proficiency in local language is required.
• Advanced level or fluency in English is required.
• Education: Bachelor’s degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience.

Senior Clinical Research Associate, Oncology

Affiliate Manager

• Intelligence Gathering: Provides input into site recommendations via intimate understanding of country and region, sites, processes and practices, and associated site performance metrics • Provides support to the Study Operations Manager (SOM)/Global Study Manager (GSM) to define local requirements for the importation/exportation processes of the investigational medical product and ancillary supplies • Study Start-Up and Activation: Deploys Global Site and Study Operations (GSSO) site strategies by qualifying and activating assigned site s • Supports processes to optimize country and site selection activities including review and assessment of the draft potential site list and provide Pre-Trial Assessment (PTA) output for site selection • Maintains a thorough knowledge of assigned protocols • Conducts study start up activities at the site level including but not limited to PTA, coordination of site activation checklist items, Informed Consent Document (ICD) finalization, Site Initiation Visit (SIV), as applicable, including management of issues that may compromise time to site activation • Ensures all the site initiation activities completed including training per site activation checklist, collect and complete necessary documentation and systems needed • Supports country specific ICD review and deployment when applicable • Ensures follow up activities are completed post PTA and SIV to ensure site readiness for First Subject First Visit (FSFV) • Partners with site monitor to ensure site monitoring readiness in anticipation of FSFV • Responsible for relationship building and operational oversight of the site • Provides support for escalated site issues related to study delivery by coordinating communications and resolution efforts (e.g., vendor, site contracts and payment issues etc.) • Ensures the strategy and approach for Investigational Product (IP) and ancillary supplies for sites and country requirement throughout the lifecycle of the study • Accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets • Responsible for enrollment support and ensures progress by responding to recruitment issues from investigators • Maintains regular communications with investigator sites to gather status updates and drive delivery to study goals ( e.g. recruitment, data entry timelines etc.) • Partners with local Regulatory Authority (RA)/ Clinical Trial Regulatory Operations (CTRO) / Site Activation Partner (SAP) to ensure timely completion on country / local registry when applicable Study Conduct and Closeout : • Acts as operational point of contact for all site level questions, liaising with and escalating to appropriate teams to respond and resolve questions • Reviews site monitoring reports • Supports the site with revision and submission of ICD documents (and amendments) • Works with other roles to maintain system management (e.g., Electronic Data Capture, Shared Investigator Platform, Site Profile and other systems as applicable) at site level ensuring alignment across platforms • During the conduct of the study, the Site Management Organization (SMO) Assessment is reviewed with the site, when applicable, on an annual basis following site initiation and updated as needed under client/ Senior SCP supervision. In addition, SMO Assessment is reviewed and updated when major staffing, contracting, or other significant site changes/issues occur to confirm that continuity and contingency plans are current • Reviews and manages site practices that differ from client practices and liaises with study management and Business Process Owners as needed • Maintains regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study level feedback • Oversees and manages of site deliverables to study targets, ( i.e. data cuts and sweeps, interim analyses, database locks), helping to oversee data is up to date and any other site facing deliverables, (i.e., investigator signatures) • Follows the study oversight plan and proactively puts in place mitigations for known and anticipated risks • Supports development and delivery, including issue resolution, of decentralized capabilities at investigator sites • Assures quality and consistency in the delivery of monitoring • Drives monitoring efficiencies and best practices for study, region and program • Supports shaping the local clinical development environment with a goal to enhance client reputation in scientific leadership • May act as a Subject Matter Expert (SME) on client systems and processes • Actively pursues efficiencies and develops best practices in the delivery of activities for site performance throughout the life cycle to increase investigator and site satisfaction strengthening site relationships Collaboration • Ensures clear and open communication with SOM • Supports the site monitor to develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Country Trials Manager (CTM) and Study Management • Coordinates with other roles and functions that interface with study sites (e.g., Study Monitor, Investigator Contracts Lead, Site Activation Partner, Clinician, etc.) optimizing communications and enhancing overall visibility into and confidence of quality of site level activities Process, Standards, and Oversight : • Oversees site utilizing and interpreting data from analytic tools, with country intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans for these risks Compliance with Parexel standards : • Complies with required training curriculum • Completes timesheets accurately as required • Submits expense reports as required • Updates CV as required • Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills: • Demonstrated experience in site management with prior experience as a site monitor • Demonstrated experience in start up activities through to site activation • Demonstrated experience in conduct and close out activities • Demonstrated knowledge of quality and regulatory requirements in applicable countries • Must demonstrate good computer skills and be able to embrace new technologies • Ability to communicate effectively and appropriately with internal and external stakeholders • Ability to adapt to changing technologies and processes • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization • Demonstrated networking and relationship building skills • Demonstrated ability to manage cross functional relationships • Proficiency in local language preferred • English proficiency is required • Ability to manage required travel of up to 75% on a regular basis Knowledge and Experience (preferred): • Good communication , presentation and interpersonal skills • Knowledge of country requirements for GCP that may be different to those of client procedures Education: • Bachelor’s degree or Registered Nurse in a related field or equivalent combination of education, training and experience (estimate at least 5 years experience ) Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end. Read More Follow Us Privacy Policy © 2025 Workday, Inc. All rights reserved.

Site Care Partner I

Clinical Research

• Liderar la estrategia estadística en múltiples estudios de vacunas.
• Colaborar en el desarrollo de protocolos, SAPs y presentaciones regulatorias.
• Coautoría de publicaciones y contribución a la innovación científica.
• Trabajo con un equipo global en un entorno flexible y compatible con el trabajo remoto.
• La posición implica colaborar con un equipo internacional y cumplir estándares regulatorios.

Biostatistician

• Provide scientifically rigorous statistical input on post-hoc and ad-hoc analysis requests to support publication projects and regulatory query responses.
• Develop statistical analysis plans, mock-up tables, and quality check plans.
• Oversee programming support activities for assigned projects and validate the accuracy, consistency, and integrity of statistical output displays generated by programmers.
• Lead multiple project teams using project management skills and statistical/programming techniques to prepare, execute, report, and document high-quality statistical analyses.
• Conduct peer reviews of project-related work performed by other statisticians, ensure compliance with regulatory requirements, and maintain project documentation and files.
• Communicate effectively and independently with the client to coordinate statistical and programming aspects of the project.
• Demonstrate a strong understanding of ICH guidelines and clinical trial design as applicable to statistics.