Partnership Project Data Coordinator Job Purpose: A Partnership Project Data Coordinator (PPDC) is responsible for administration and maintenance of training role assignments in the Parexel or Client Learning Management System (LMS). The PPDC is also responsible for managing and controlling access to client accounts and other client systems as applicable Accountability: Learning Management Systems (LMS): • Manage access and training curriculum assignment to Parexel LMS Create client accounts and administrate access to Client LMS and other Client systems as required. Complete regular quality checks to verify training curricula, accounts, and system access assignments Compliance & Reporting: • Collaborate with Partnership Training team to maintain metrics and run reports for compliance/KXIs Provide support for quality issues/CAPAs, audits, and inspections for assigned partnership Process Improvements: • Maintain sound familiarity with Parexel systems and related processes and remain informed about developments in relevant regulations and guidelines that may impact partnership training. Administration: • Responsible for administration tasks to support the partnership teams and partnership training curriculum assignments. Skills: Good interpersonal, verbal, and written communication skills Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Ability to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organization Good computer skills, including proficiency in multiple systems (e.g., LMS, MS Office products) Knowledge and Experience: Relevant experience in an administrative or similar role required Prior experience within a CRO or pharmaceutical environment desirable Education : English fluency required (written and verbal) Bachelor’s degree or equivalent background preferred. #LI-REMOTE

Key Accountabilities: Project Management: Ability to fill Statistical Programming Lead role on projects Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to. Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget. Monitor project resourcing, project budgets, and identify changes in scope. Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. Review statistical analysis plans and mock-shells. Review database set-up specifications. Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities. Interact with sponsors and internal stakeholders with regard to statistical programming issues. Assist project teams in the resolution of problems encountered in the conduct of their daily work. Statistical Programming for Assigned Projects: Deliver best value and high-quality service. Check own work in an ongoing way to ensure first-time quality. Use efficient programming techniques to produce/QC derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings. Produce/QC dataset specifications and other process supporting documents and submission documentation. Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, data listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP, and/or other international regulatory requirements. Training: Maintain and expand local and international regulatory knowledge within the clinical industry. Develop knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting, SAS, and processes/procedures within other Parexel functional areas. Provide relevant training and mentorship to staff and project teams. Lead knowledge sharing forums and proactively support the development of the wider department. General: Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance. Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required. Proactively participate in and/or lead process/quality improvement initiatives. Provide consultancy to internal and external sponsors with regard to statistical programming tasks. Represent Parexel at sponsor marketing and technical meetings. Assessment of technology and processes, to facilitate best practices and increase quality, efficiency, and productivity. Represent Statistical Programming on cross-functional technical initiatives. Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions). Skills: Excellent analytical skills. Advanced knowledge of SAS programming techniques. Extensive knowledge and understanding of the programming and reporting process. Good knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11. Knowledge of the efficacy endpoints and analysis techniques specific to the disease being treated. Ability to learn new systems and function in an evolving technical environment. Strong project management skills. Strong organizational skills, ability to manage competing priorities, and flexibility to change. Attention to detail. Ability to successfully lead and mentor a global team. Work effectively in a quality-focused environment. Excellent time management in order to meet daily metrics or team objectives. Show commitment to and perform consistently high quality work. Strong business/operational skills that include customer focus, commitment to quality management, and problem solving. Demonstrate commitment to refine quality processes. Good presentation skills. Ability to negotiate and influence in order to achieve results. Good business awareness/business development skills (including financial awareness). Client-focused approach to work. Good negotiation skills. Knowledge and Experience: Competent in written and oral English. Excellent communication skills. Proven record of successfully leading teams in a statistical programming environment. Education: Educated to degree level in a relevant discipline and/or equivalent work experience. #LI-REMOTE

Manage The Relationship With Operations Establish and maintain strong partnerships with Operational management assigned partners (likely at Director levels), other Quality and business functions (e.g., Risk Management, Project Quality & Risk Leads) and with Line Manager to ensure continuous improvement and regulatory complianceDeputize for the Head of the PQRM group as assigned, representing specific topicsProvide transparency to compliance with quality expectations (and defining those expectations) to Operational management (e.g., via metrics, reports, meetings attended / chaired)Represent Data Services PQRM at management meetings both within Parexel Quality, Operations and externally where assignedPromote / champion the Quality Management System within both the group and the Operational teams via Operational managementProvide input to Quality Forums to facilitate meaningful discussion that leads to action on key risk areasPropose, lead and implement PQRM initiatives to accomplish PQRM’s goalsSupport development and implementation of strategyPerform other Quality related tasks as assigned Independently Provide Quality Input To Audits/inspections Support audit/inspection preparation including helping team set priorities and reviewing key documentsProvide onsite (office) or remote support as neededLead project team to investigate more complex issues and root causesFacilitate development of robust CAPA for more complex issuesReview audit/inspection responses prior to final QA review if necessaryContribute to critical issue resolution by providing expert quality advice and directionServe as an eQMS SME Independently provide quality advice as assigned Respond to consultancy requests to enable project teams to deliver first-time qualityReview and approve SOP deviations using ICH-GCP, Parexel processes, regulatory requirementsConsult SMEs including other quality experts when necessary to resolve issuesReview and investigate possible SOP deviations as requestedRepresent Parexel Quality at client or internal meetingsAct as SME on functional topics and Quality expectations, ensuring adequate input to SOP creation / revisionAct as a consultant to operations on the QMS and applicable regulationsIdentify continuous improvement opportunities, facilitate the development of recommendations and champion implementationMaintain industry awareness including future technology, business, Quality and regulatory direction and take initiative in sharing relevant information. Translate for Parexel’s useProvide feedback via the appropriate channel when gaps or issues are identified with Parexel processesPropose ideas to PQRM leadership related to departmental efficiencies, potential improvements, or innovationsEscalate issues to Leadership as necessary Facilitate identification, investigation and remediation of Quality Issues (QIs) as assigned Ensure triage of relevant quality issues in electronic quality management system (eQMS) ensuring appropriate classification, as assignedWhere assigned as QM Representative, assist QI Manager on more complex QIs in;Supporting initial assessment of Serious Breach of GCPdeveloping containment actionsfacilitating QI team to investigate root causesfacilitating development of robust corrective and preventive actions (CAPA)assessing effectiveness of CAPA as necessary with QI team and action ownersUse available tools and methodologiesServe as an eQMS SMEEscalate issues to Leadership as necessary Independently develop and cultivate transparent quality relationship on assigned Partnerships, to achieve and maintain inspection-ready performance: Maintain understanding of Parexel SOPs and Partnership expectations - and how they interactProvide consultancy, to ensure efficiency and regulatory compliance of proposed approaches when not following Parexel standardsSharing of Quality information and analyses, internally (e.g., QI reports)Be a consistent internal point of contact within Quality. Facilitate provision of support from the wider Parexel Quality organization / Quality Management System as neededAudit/inspection support: Represent Parexel Quality and ensure the partnership /project team are prepared for audit, supported throughout and reviewing audit responsesQuality Issue support: Be assigned as QM Representative on Partnership QIs Independently facilitate the Risk Evaluation process Work with Quality and Operational management to identify risk areasDevelop plans for the team to investigate specific process or account risksSupport/ lead complete assigned Risk Evaluations including; identifying relevant questions & identifying project types to use during the assessment, ensuring Operational Leadership buy-in to the approach and the questions, supporting others performing evaluation, discussing the results, defining suggested actions and providing input to a presentation of the resultsConfirm agreed mitigations have been integrated into departmental plansEncourage documenting lessons learnedAssess effectiveness of mitigations with management Maintain compliance with Parexel standards and regulatory requirements Comply with required training curriculaTake part in personal goal setting and performance review activitiesAccurately complete timesheet as requiredSubmit expense reports as required by SOPUpdate CVs and sign JD as required by SOP

Job Description Summary :- Responsible for management of scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Reports (PSRs) including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports, United States Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Annual Risk-Benefit Evaluation (ARBE) report, Risk Management Plan (RMP), Safety statements, Health Hazard Evaluation (HHE), Drug Safety Report (DSR), Clinical Overview (CO), Safety Evaluation Report (SER), Investigational New Drug Annual Report (INDARs) as well as preparing document of comparison between local and global labeling document (if applicable) and checking of International Non-proprietary names (INNs) for inclusion in a PSR as per client requirements and signal detection and management (where applicable). Generating Line Listings, creating drug lists/drug folders, performing regulatory submissions, tests electronic submissions gateways, and tracking compliance monitoring of submissions in accordance with client/international conventions Responsible for preparing the narratives associated with the client’s/sponsor’s products from clinical trials for Clinical Study Reports (CSRs) or in order to support any health authority requests in accordance with regulatory and client’s/sponsor’s requirements Scheduling and Attending meetings/ Drafting meeting agenda and minutes/Tracking action items. Job Description:- Preparing/updating/merging RMPs/Company Core-RMPs (CC-RMPs), preparing a health authority response document along with RMS update in accordance with client requirements/conventions and SOPs. Managing scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports, United States Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Annual Risk-Benefit Evaluation (ARBE) report, Safety statements, Health Hazard Evaluation (HHE), Drug Safety Report (DSR), Clinical Overview (CO), Safety Evaluation Report (SER), Investigational New Drug Annual Report (INDARs), comparison document between local and global labeling document (if applicable)and checking of International Non-proprietary names (INNs) for inclusion in a PSR as per client requirements and conventions and SOPs Conducting critical appraisal and systematic review of literature with a focus on background epidemiology, specifically information on the incidence, prevalence and risk factor in patient populations, for inclusion in drug Safety Reports and RMPs Providing input and developing literature search strategies for the epidemiology section of safety reports Applying epidemiological methods and calculations to data available in literature to support the background rates of the issues under evaluation for the safety reports Generating Line Listings for submissions/ to identifying discrepancies and ensuring resolution of the discrepancies Revising document drafts based on the review comments from team members to ensure inclusion of all relevant input. Ensuring that all work is complete and of high quality prior to team or client distribution. Confirm data consistency and integrity across the document. Performing aggregate report compliance activities including quality review to check the data/facts and internal consistency across various type of aggregate reports including but not limited to PBRERs, Ad hocs, HHEs, LJDs, tables, RMP, Pharmacovigilance System Master File (PSMF) document (as applicable). Distributing of final reports to the stakeholders including partners, affiliates and submission to health authorities, according to the agreed timelines, distribution lists and email templates (as required). Scheduling and Attending meetings/ Drafting meeting agenda and minutes/Tracking action items. #LI-REMOTE

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The System Validation Services (SVS) team supports and improves the compliance of the company’s technology solutions and technology solution offerings by standardized, harmonized, and streamlined validation/qualification activities based on the current GxP requirements and risk management principles. Support efforts to define, adopt, and oversee compliance to processes and standards as the fundamental baseline for Infrastructure Life Cycle, Software Development Life Cycle, Technology Quality Life Cycle and delivery. Supports efforts, in collaboration with the business to monitor, identify and implement continuous process improvement across all technology business units. Supervise and ensure the effective implementation of technology solutions for quality management, aiding in delivering products and services to customers. Offer expertise to ensure technology solution projects comply with established standards. Key Accountabilities: Accountability Validation Representative Lead specific tasks for executing Parexel system’s validation strategy. Plan and oversee a risk-based approach to the validation of Parexel systems, in support the Technology Solution Validation Team. Support the provision of validation consultancy, guidance and oversight to ensure compliance with applicable regulatory and quality requirements, and applicable Policies and SOPs. Conduct Periodic Reviews to verify the validated state of each technology solution has been maintained and report findings. Support risk management activities to identify, assess, and control technology-related risks eliminating risks or reducing risks to an acceptable level. Assist with logistical support and initial planning for audit/inspection hosts and provides standard presentation for covering Infrastructure Life Cycle, Software Development Life Cycle and Technology Quality Life Cycle in audit. Assists audit/inspection hosts with data collection and initial collation for the responses. Support activities for development of risk management processes in line Assist with data collection and initial review of Requests For Information (RFI). Performs general and administrative tasks including accurate and timely completion of timesheet. Standards & Quality Framework Assists Process Owners and Stakeholders to support the design, development, implementation, and maintenance of Validation Framework Controlled Documents. Contribute to the development and maintenance of Managed Information and guidance in support of the Validation Framework. Contribute to the development and delivery of training material in support of the Validation Framework. Skills: Entry/mid-level experience in computer technology quality and compliance (including computerized system validation) and the pharmaceutical industry across multiple disciplines within Clinical Drug Development (Phase I/II/III/IV) and/or Manufacturing. Basic knowledge of continuous improvement methodologies. Exhibits competency across core project management activities. Excellent interpersonal, verbal and written communication skills, business understanding, negotiation skills and strong organizational skills. High ability to work in a customer-focused, fast-paced and rapidly changing environment with the high ability to prioritize workload and manage multiple and varied tasks with enthusiasm and some supervision. Highly motivated, seeks opportunities for development, client-focused, having the ability to work with guidance on own initiative. Exhibits a sense of urgency when addressing problems and ensures completion of commitment. Culturally aware and ability to think and work globally. Intermediate desktop software skills (MS Office, Excel, Adobe PDF etc.). Knowledge and Experience: Entry/mid-level Clinical trials and / or Clinical trials and /or research work experience required, with emphasis on GCP and technology compliance. Familiar in technology as it relates to clinical trial activities, including System Life Cycle process and applicable GCP regulations pertaining to Computer Systems. Entry knowledge of project management, Lean Six-Sigma, auditing and/or risk management methodologies. Education: Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification, or 3+ years clinical research experience.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Overall Be the accountable Lead for Site Payment Services related queries on Accountabilities assigned studies and point of contact for project teams Proactively and effectively solves customer problems, and accepts responsibility for actions Work closely with Project Leadership, Global Site Contracts, EClinical Business Implementation, Global Clinical Operations, and other internal Site Payment Services team members to obtain additional information required to perform tasks, when applicable Participate as the Lead representative of the Investigator Payment team in study start-up meetings, including payment strategy meetings, to ensure initial funds setup requirements are documented for seamless payment processing Lead and follow-up on audits/inspections • Knowledge of clinical trial pricing/budgeting tools and how to reflect operational changes within the tools • Thorough knowledge of Parexel’s SOPs, Operational Guidelines and Work Instructions procedures Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, and expenses) Skills: Strong interpersonal, verbal, and written communication skills Ability to make decisions and advise other staff even in ambiguous situations Ability to conduct root cause analysis in problem solving and process development. Strong customer focus, ability to interact professionally • Patient, Quality and Client focused approach to work Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Expert in using MS Excel for spreadsheet analysis Strong proficiency in use of MS Outlook, Teams, PowerPoint, and Word Analytical mind with strong attention to detail Commitment to high quality work and consistent performance Comfortable with working in a decentralized matrix environment and being a conversant team player Delivers standard/typical work deliverables without issues Thoroughly understands fundamentals of CRO industry and how Investigator Payments influence in the organization Knowledge and Experience : 4+ years’ experience is preferred within a Clinical Research Organization; Business; Finance/Accounting; or other comparable experience Education: Advanced to excellent English level for non-native English speakers Minimum Bachelor’s degree or equivalent degree In depth understanding of the set-up and payment process; including ability to analyze agreements Collection of information from all teams/systems/tools wherever needed on a timely and proactive basis Analyze and present data to various stakeholders Trains team members within the Site Payment Services Discover and implement opportunities for process efficiencies End to end Keeps internal and external team members aware of site payment status management of Site and issues Payments (if Accurately authorize study setups before starting payments applicable) Resolve escalated second line helpdesk issues for assigned portfolio Assist in the preparation of project status reports as needed Works with IFA and project team to ensure appropriate funding prior to administering payments Proactively participates in Project Strategy Meetings (PSM), providing input to payment strategy planning for incoming studies Compliance with the Investigator payment timelines as per the contractual terms Resolve payment discrepancies to ensure accurate processing of payments Provide payments reports for assigned projects to customers as requested

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The application analyst responsibility is to work with the Oracle EBS Finance 12.2.4 systems functions and other systems of the company related to finance and to ensure it aligns with the business objectives of the organization. This individual’s principal goals are to resolve day to day issues raised by business, develop and manage application solutions for finance related systems within the organization. The analyst will plan, coordinate, and design to ensure project goals and objectives are accomplished within prearranged time frames and budgets. The senior analyst of IT will work closely with decision makers in other departments to identify, recommend, develop, implement, and support cost -effective technology solutions for all aspects of the organization. The successful candidate will have strong Oracle EBS Finance & Project accounting support and implementation skills. Key Accountabilities Analyze and provide resolution to day-to-day business issues raised through ticketing system Analyze, design and/or develop best practice business needs through technology solutions. Interact with Accounting, Finance and Procurement teams to understand their requirements and design solutions. Define new and refine existing business processes. Convert process improvements recommendations to actionable systems requirements. Participate in requirement gathering, aligning business requirements and best practices to implement a technical solution. Create systems documentations including unit test, solution designs Support Quality Assurance efforts (test planning and execution) for periodic releases and new systems implementations. Contribute to continuous improvement and development of internal processes. Help accelerate adoption of the very best engineering practices, while maintaining knowledge on industry innovations, trends, and practices. Required Skills: Ability to co-ordinate across groups including motivating, developing, and coordinating team members. Client focused approach to work. Excellent interpersonal, verbal, and written communication skills. A flexible attitude with respect to work assignments and new learning. Ability to manage multiple and varied tasks with enthusiasm and prioritize workload for oneself and the team. Willingness to work in a matrix environment and to value the importance of teamwork. Knowledge and Experience : Design, develop, test and implement features and code on Oracle EBS R12 using OAF, Workflow and AME. Design and Implement Web Services using SOA. Help End Users Understand application features to accomplish their business purposes. Partner with Database and Middleware Administrators to achieve great application performance. Demonstrate advanced skills while coaching and mentoring less senior team members. Document code and projects so others can easily understand. Fulfill customer requirements as measured in customer survey scores. Show insight, know your application design & data, offer simple, working solutions. Apply team coding, documenting, and testing standards and recommend process improvements. Recognize upstream and downstream impacts; communicate effectively (verbally & in writing). Learn the Business Process Your Application Supports so your code will better support the business. Improve your application and team processes. Decrease incidents and increase uptime of your application. All other duties as assigned. Attendance as required by department. Remain compliant with our policies, processes, and legal guidelines. Code expertly in your application while following team coding and testing standards. Job Requirements: Bachelor’s degree or equivalent in Computer Science, Information Systems, or closely related field of study. Minimum of 3 - 5 years using Oracle EBS. Minimum of 2 - years experience working with (Procurement, Fixed Assets, AP, General Ledger) or Oracle Projects Billing, costing and Revenue cycle. Strong knowledge on SQL/PLSQL. Full lifecycle experience on OAF pages deployment. Should have worked on SOA, understanding of Web Services. Should have worked on Oracle EBS R12 Workflow, AME. Good to have Oracle APEX experience. Good to have experience on XML Publisher Reports. Good to have OCI experience. Must possess excellent financial and analytical skills. Preferred Experience: Application Support Financial Services. Experience working with PL/SQL. Language Skills Ability to effectively communicate in the English language verbally and in writing. Ability to read and interpret technical journals, specifications, international technical standards, etc.

Job Profile Summary The Statistical Programmer II provides technical expertise for the conduct of clinical trials, and works with minimal supervision to support various programming activities related to the analysis and reporting of clinical study data. In addition, the Statistical Programmer II may fill the Statistical Programming Lead role (or part of that role) on small, non-complex projects. Job Description Key Accountabilities: Project Management Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. Statistical Programming For Assigned Projects Deliver best value and high quality service. Check own work in an ongoing way to ensure first-time quality. Use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings. Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation. Training Maintain and expand local and international regulatory knowledge within the clinical industry. Develop knowledge of SAS and processes/procedures within other PAREXEL functional areas. Provide relevant training and mentorship to staff and project teams as appropriate. General Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance. Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required. Proactively participate in process/quality improvement initiatives. Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions). Skills Excellent analytical skills. Proficiency in SAS. Knowledge and understanding of the programming and reporting process. Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11. Ability to learn new systems and function in an evolving technical environment. Ability to manage competing priorities and flexibility to change. Attention to detail. Ability to successfully work as part of a global team. Work effectively in a quality-focused environment. Effective time management in order to meet daily metrics or team objectives. Show commitment to and perform consistently high quality work. Business/operational skills that include customer focus, commitment to quality management, and problem solving. Knowledge And Experience Competent in written and oral English. Good communication skills. Education Educated to degree level in a relevant discipline and/or equivalent work experience. Show more Show less

The Investigator Setup Specialist I receives assignments based upon tickets submitted to the Investigator Fund Setup in the Assyst Ticketing tool. The Investigator Setup Specialist I is expected to understand the basic requirements to create a new or modify an existing budget template with supervision. The most essential knowledge component required is the ability to understand the contract expense details and apply the budget breakdown to the design pattern in the investigator payment system. Accurate budget template setups based upon fully executed contractual agreement Work closely with payment specialists and other internal team members to obtain additional information required to perform the budget template setup, when applicable Notify the assigned Payment Specialist upon completion of the budget template to request the review and approval of the setup to confirm accuracy compared to the contractual agreement Complete updates to the budget template, as required, based upon quality control or amendment requests Ensure that all documentation is included in the ticket request for tracking purposes Submit ticket requests to the Accounts Payable team to create payee setups associated with the budget template; ensuring that all requirement documents are included and pre-requisites are met Thorough knowledge of Parexel’s SOPs, Operational Guidelines and Work Instructions procedures Keeps internal team members aware of site budget and payee setup Accurately setup study site budget and payee before starting payments Support payment leads to facilitate payments and resolve queries Skills Proficient interpersonal, verbal, and written communication skills Ability to proactively identify and solve problems Strong customer focus, ability to interact professionally Patient, Quality and Client focused approach to work Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Proficient in using MS Excel for spreadsheet analysis Proficient in use of MS Outlook, Teams, PowerPoint, and Word Effective time management to meet daily metrics Commitment to high quality work and consistent performance Comfortable with working in a decentralized matrix environment and being a conversant team player Show more Show less

Accountability Supporting Activities Build Grant Estimate Timely preparation of accurate and competitive Clinical Study grants (Phases I – IV for all clinical indications) via proficient usage of any Clinical Study Pricing Tool that PAREXEL is required to use to support our Clients’ needs. The default, currently licensed tool in this regard is Grants Manager. Collaborate to prepare competitive budget concepts for Pre-sales business Proposals in conjunction with other members of the Proposal team while remaining compliant with the Request for Proposal (RFP) and PAREXEL internal policies. Parexel International Job Description JD Version date: 26 Nov 24 TP-HR-WW-001-12.d Effective Date: 22 Sep 23 Related to: SOP-HR-WW-001 Page 2 of 3 Developed from TP-BPM-WW-032; related to SOP-BPM-WW-001 Subject Matter Expert and Lead on the creation, revision, escalation, and approval process of Clinical Study grants for awarded Projects with the assigned Site Contracts Leader and Study Project Leader and Project Director, as appropriate. Preparation of additional Post Award Clinical Study grant analyses for the assigned Site Contracts Leader and Study Project Leader and Project Director, as appropriate. Participation in strategy sessions and budget reviews when requested to develop win themes, identify, and assess competitor’s benchmarks and discuss client needs. Ensure that all Clinical Study grant information is performed in full compliance with Fair Market Value (FMV) principles and the Physician Payments Sunshine Act. Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) Display good knowledge sharing capabilities, share lessons learned and new scenarios with the team. Deliver and maintain client-focused Grants analysis to measure performance and proactively identify issues for resolution Support & build departmental or functional training plans, content & delivery General Administration & Operations Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and PAREXEL SOPs Participate in, Parexel and department system/standards improvement activities or committees, task force groups as needed, including change management Ensure agreed levels of productivity/billability are maintained Complete routine administrative tasks in a timely manner (e.g. timesheets, training, travel expense claims). Ensure compliance with travel and billability guidelines for department, region, or function, are met where appropriate. Travel as needed. Maintain a positive, results orientated work environment, building partnerships, and modeling teamwork, communicating to the team in an open, balanced and objective manner Ensure implementation of process improvements in response to client and team feedback and quality audits Look within and beyond CRS to encourage teamwork, quality and productivity efforts to the benefit of CRS and PAREXEL Skills: Strategic Thinking skills that support the ability to create a sense of urgency and take a proactive, solutions-based approach Excellent analytical and problem-solving skills, to define and resolve issues in a variety of complex situations Leverage communication across boundaries and uses multiple communication mechanisms to convey information across functional lines and upward within Parexel. Parexel International Job Description JD Version date: 26 Nov 24 TP-HR-WW-001-12.d Effective Date: 22 Sep 23 Related to: SOP-HR-WW-001 Page 3 of 3 Developed from TP-BPM-WW-032; related to SOP-BPM-WW-001 Client focused and demonstrate ability to create and maintain trust with the client through project and personal interactions; act as a trusted advisor and become involved in the client’s decision-making process. Ability to resolve issues independently and knows when to call on senior management for involvement in communicating to external & internal customers after assessing the organizational implications of the interaction and consultation with Senior Management. Familiarity with standard business and eClinical systems used in Clinical Research Proficient in Microsoft Excel, Power Point, and Word software Ability to become proficient with Parexel systems Advanced ability to successfully manage a full workload across multiple and varied projects/tasks with enthusiasm and prioritize workload with attention to detail Outstanding negotiation, influencing and organizational skills Demonstrable experience of stakeholder/relationship management with a client focused approach to work. Able to understand the business implications of decisions and impact on customer An ability to assess situations and make and carry through difficult decision Ability to successfully work in a (‘virtual’) team environment Knowledge and Experience: 3 – 5 years’ work experience in clinical site budget development, (use of Grant Plan or Grant Manager) in a similar role within the managed care, pharmaceutical or bio-technology industries. Experience in the use of industry benchmarking databases and other tools utilized to ensure fair market value in the development of investigator grants Education: Educated to degree level (biological science, pharmacy, or other health-related discipline Show more Show less

Position Summary The Portfolio Specialist, Access Operation is responsible for support managing and optimizing a portfolio of projects across Pricing & Market Access, Evidence Evaluation. Real World Evidence, Advanced Analytics Consulting to maximize value and align with organizational strategy. The Portfolio Specialist will play a crucial role in supporting broader program management activities, ensuring smooth coordination across various workstreams, and maintaining compliance with company standards. The ideal candidate will have a strong background in life sciences and familiarity with clinical trial processes. Key Responsibilities Broader Program Management Evaluate and prioritize portfolio components based on strategic alignment, risk, and potential return Monitor portfolio performance and make recommendations for improvements Track monthly opportunities and assess off-label content Screen the pipeline to identify new opportunities and ensure alignment with current projects Track company newsletters and clinical trial pipeline information Maintain case studies based on completed projects in different therapy areas and organograms of the clients Contracting and Tracking Support the Subject Matter Experts (SMEs) / Account Leads with contracting tasks and track their progress Quality and Compliance Coordination Coordinate the review process for reports by quality leads within the Service Lines Conduct SOP audit spot checks Implement changes to SOPs, including templates and processes Ownership pf client feedback log: gather and action client feedback Team Coordination Coordinate across the cross-Service Line teams for various indications Manage program coordination with the wider Parexel organization / Business Units / Service Lines Timelines and Resource Management Maintain the timeline tracker updated across the portfolio and link current and future projects with resourcing. Leverage data and insight from ongoing projects and workstreams to identify new opportunities Reporting and Meetings Prepare slides for Business Review Meetings and Quarterly Business Reviews (QBR) Qualifications Bachelor’s degree in a scientific related field (e.g., Life Sciences, Pharmacy). Strong background in scientific writing and familiarity with clinical trials and regulatory requirements. Excellent organizational and time management skills. Strong communication skills, with the ability to work collaboratively across teams. Proficiency in project management tools and software. Detail-oriented with a strong focus on quality and compliance. Ability to manage multiple projects simultaneously and meet deadlines. Proficiency in Microsoft Office Suite, particularly Excel and PowerPoint Preferred previous experience in portfolio management, or a related role. Skills And Competencies Attention to detail and ability to manage and track multiple projects/priorities, ensuring timely completion and adherence to quality standards. Communication: Strong written and verbal communication skills, with the ability to convey complex information clearly and concisely. Scientific Writing: Proficiency in scientific writing, with the ability to assess and evaluate off-label content. Compliance and Quality Management: Experience in conducting quality checks, SOP audits, and ensuring compliance with regulatory requirements. Team Coordination: Ability to coordinate across multiple teams and workstreams, ensuring smooth execution of program activities. Analytical Skills: Strong analytical skills, with the ability to conduct revenue forecast deep-dives and identify opportunities within workstreams. Location: Bengaluru -Office based Show more Show less

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Required Skills: Build CI/CD tools integration/operations, and full automation of CI/testing leveraging Azure DevOps. Lead an offshore small team of DevOps engineers to build and operate the CI/CD ecosystem. Develop and automata scalable Continuous Integration pipelines. Actively participate in the ongoing design and implementation of systems and tools across the cloud data stack. Build dashboards to monitor the health of the data pipelines and environment. Collaborate with internal development and QA teams to help ensure end-to-end quality. Write and maintain documentation infrastructure. Troubleshoot issues along the CI/CD pipeline. Work directly with third-party vendors and infrastructure engineering to troubleshoot and fix infrastructural issues impacting the DevOps and Data ecosystems. 3-5 years of experience in software development with minimum 2 years of cloud computing. Knowledge of python. Education: Bachelor's Degree or equivalent combination of education and experience.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Duties may include but are not limited to: Global Coverage Americas, Europe and APAC regions. Strong Workday knowledge / workday certification or extensive experience (Workday Absence and Time). Strong Communication skills that is able to translate business needs with configuration in the system. Knowledge of the region norms. Support time management and absence for the above regions. Documentation, Requirements, Workbook, Sprint supports. Write & manage plan for delivery. Define populations needing to provide input. Support and influence expectations & involvement of SMEs. Support design discussions and hold meetings for requirements gathering, clarifications. Identify and communicate risks, roadblocks or concerns. Provide visibility on decisions / guidance to leadership. Ensure all SMEs have common understanding and approve final deliverables with help from team/SMEs. Provide support and escalations as needed. Support Completion of WD workbooks with SMEs. Support Jira (Open, groom, & close tickets). Identify policy & process changes. Identify issues / blockers. Support sub-workstream lead with requirements elicitation, grooming. Jira management as needed. Coordination as requested. Identify issues/blockers. Accustomed to SDLC and Agile process. Qualifications Proficient in multiple workday modules like Core HR, Time and Absence. Knowledge of the region norms. Backup for workstream leads. Support time management and absence for the above regions. Documentation, Requirements, Workbook, Sprint supports. Good understanding of business requirements and reporting strategies. Ability to work independently and be a team player. Ability to work in second shift if required to cover Asia Pacific regions. Strong Workday knowledge if possible workday certificate or extensive experience. Strong Communication skills that is able to translate business needs with configuration in the system. Basic Qualifications Bachelor's Degree or equivalent combination of education and experience. Five plus years of workday experience with proficiency in multiple workday modules. Workday Absence/Time Tracking Certification preferred

Additional Locations India-Bengaluru; India-Bengaluru-Remote; India-Chandigarh; India-Chandigarh-Remote; India-Hyderabad-Remote; India-Mohali; India-Mohali-Remote; India-Mumbai; India-Mumbai-Remote Job ID R0000032694 Category Quality Management ABOUT THIS ROLE The System Validation Services (SVS) team supports and improves the compliance of the company’s technology solutions and technology solution offerings by standardized, harmonized, and streamlined validation/qualification activities based on the current GxP requirements and risk management principles. Support efforts to define, adopt, and oversee compliance to processes and standards as the fundamental baseline for Infrastructure Life Cycle, Software Development Life Cycle, Technology Quality Life Cycle and delivery. Supports efforts, in collaboration with the business to monitor, identify and implement continuous process improvement across all technology business units. Supervise and ensure the effective implementation of technology solutions for quality management, aiding in delivering products and services to customers. Offer expertise to ensure technology solution projects comply with established standards. Key Accountabilities: Accountability Validation Representative Lead specific tasks for executing Parexel system’s validation strategy. Plan and oversee a risk-based approach to the validation of Parexel systems, in support the Technology Solution Validation Team. Support the provision of validation consultancy, guidance and oversight to ensure compliance with applicable regulatory and quality requirements, and applicable Policies and SOPs. Conduct Periodic Reviews to verify the validated state of each technology solution has been maintained and report findings. Support risk management activities to identify, assess, and control technology-related risks eliminating risks or reducing risks to an acceptable level. Assist with logistical support and initial planning for audit/inspection hosts and provides standard presentation for covering Infrastructure Life Cycle, Software Development Life Cycle and Technology Quality Life Cycle in audit. Assists audit/inspection hosts with data collection and initial collation for the responses. Support activities for development of risk management processes in line Assist with data collection and initial review of Requests For Information (RFI). Performs general and administrative tasks including accurate and timely completion of timesheet. Standards & Quality Framework Assists Process Owners and Stakeholders to support the design, development, implementation, and maintenance of Validation Framework Controlled Documents. Contribute to the development and maintenance of Managed Information and guidance in support of the Validation Framework. Contribute to the development and delivery of training material in support of the Validation Framework. Skills: Entry/mid-level experience in computer technology quality and compliance (including computerized system validation) and the pharmaceutical industry across multiple disciplines within Clinical Drug Development (Phase I/II/III/IV) and/or Manufacturing. Basic knowledge of continuous improvement methodologies. Exhibits competency across core project management activities. Excellent interpersonal, verbal and written communication skills, business understanding, negotiation skills and strong organizational skills. High ability to work in a customer-focused, fast-paced and rapidly changing environment with the high ability to prioritize workload and manage multiple and varied tasks with enthusiasm and some supervision. Highly motivated, seeks opportunities for development, client-focused, having the ability to work with guidance on own initiative. Exhibits a sense of urgency when addressing problems and ensures completion of commitment. Culturally aware and ability to think and work globally. Intermediate desktop software skills (MS Office, Excel, Adobe PDF etc.). Knowledge and Experience: Entry/mid-level Clinical trials and / or Clinical trials and /or research work experience required, with emphasis on GCP and technology compliance. Familiar in technology as it relates to clinical trial activities, including System Life Cycle process and applicable GCP regulations pertaining to Computer Systems. Entry knowledge of project management, Lean Six-Sigma, auditing and/or risk management methodologies. Education: Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification, or 3+ years clinical research experience.

Additional Locations India-Bengaluru; India-Bengaluru-Remote; India-Chandigarh; India-Chandigarh-Remote; India-Hyderabad-Remote; India-Mohali; India-Mohali-Remote; India-Mumbai; India-Mumbai-Remote Job ID R0000030606 Category IT ABOUT THIS ROLE Key Accountabilities : Using Microsoft Azure data PaaS services, design, build, modify, and support data pipelines leveraging DataBricks and PowerBI in a medallion architecture setting. If necessary, create prototypes to validate proposed ideas and solicit input from stakeholders. Excellent grasp of and expertise with test-driven development and continuous integration processes. Analysis and Design – Converts high-level design to low-level design and implements it. Collaborate with Team Leads to define/clarify business requirements, estimate development costs, and finalize work plans. Run unit and integration tests on all created code – Create and run unit and integration tests throughout the development lifecycle. Benchmark application code proactively to prevent performance and scalability concerns. Collaborate with the Quality Assurance Team on issue reporting, resolution, and change management. Support and Troubleshooting – Assist the Operations Team with any environmental issues that arise during application deployment in the Development, QA, Staging, and Production environments. Assist other teams in resolving issues that may develop as a result of applications or the integration of multiple components. Knowledge and Experience : Understanding of design concepts and architectural basics. Knowledge of performance engineering. Understanding of quality processes and estimate methods. Fundamental grasp of the project domain. The ability to transform functional and nonfunctional needs into system requirements. The ability to develop and code complicated applications is required. The ability to create test cases and scenarios based on specifications. Solid knowledge of SDLC and agile techniques. Knowledge of current technology and trends. Logical thinking and problem-solving abilities, as well as the capacity to collaborate. Primary skills: Cloud Platform, Azure, Databricks, ADF, ADO. Sought: Denodo, SQL, Python, PowerBI, CDC Tools (preferably Striim). General Knowledge: PowerApps, Java, DataIKU. 6-10 years of experience in software development with minimum 2 years of cloud computing. Education : Bachelor of Science in Computer Science, Engineering, or related technical field.

Duties May Include But Are Not Limited To Global Coverage Americas, Europe and APAC regions. Strong Workday knowledge / workday certification or extensive experience (Workday Absence and Time). Strong Communication skills that is able to translate business needs with configuration in the system. Knowledge of the region norms. Support time management and absence for the above regions. Documentation, Requirements, Workbook, Sprint supports. Write & manage plan for delivery. Define populations needing to provide input. Support and influence expectations & involvement of SMEs. Support design discussions and hold meetings for requirements gathering, clarifications. Identify and communicate risks, roadblocks or concerns. Provide visibility on decisions / guidance to leadership. Ensure all SMEs have common understanding and approve final deliverables with help from team/SMEs. Provide support and escalations as needed. Support Completion of WD workbooks with SMEs. Support Jira (Open, groom, & close tickets). Identify policy & process changes. Identify issues / blockers. Support sub-workstream lead with requirements elicitation, grooming. Jira management as needed. Coordination as requested. Identify issues/blockers. Accustomed to SDLC and Agile process. Qualifications Proficient in multiple workday modules like Core HR, Time and Absence. Knowledge of the region norms. Backup for workstream leads. Support time management and absence for the above regions. Documentation, Requirements, Workbook, Sprint supports. Good understanding of business requirements and reporting strategies. Ability to work independently and be a team player. Ability to work in second shift if required to cover Asia Pacific regions. Strong Workday knowledge if possible workday certificate or extensive experience. Strong Communication skills that is able to translate business needs with configuration in the system. Basic Qualifications Bachelor's Degree or equivalent combination of education and experience. Five plus years of workday experience with proficiency in multiple workday modules. Workday Absence/Time Tracking Certification preferred Show more Show less

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Purpose: The Project Specialist I is developing project plans, providing project level reports and metrics to inform project oversight, progress reporting and decision making by the Project Leader (PL) and Functional Leads (FLs), to ensure timeliness and quality of project deliverables and control the project budget. The Project Specialist I will be predominantly assigned to late phase and Enterprise projects. The Project Specialist I is working on under Line Manager oversight in all project lifecycle phases and depending on the acquired experience and independence, an assignment to Biotech& Emerging client’s projects, as well as to assist project start up and close out can be considered. Key Accountabilities: Core services provided by the Project Specialist I include, but are not limited to: Project Management Plans initial set up and maintenance with Project Leader input Maintenance of selected information in the integrated project management system Project reports, compliance and other metrics for project operational review, client and internal reporting and project oversight Initial Review of selected financial areas. Cooperation with Project Leader and Functional Leads on action plans and follow up with the project team on action items Oversight of project team list, project system accesses and respective reviews Project Initiation Management : Updating and customizing of systems and tools and project plans according to applicable SOPs, if needed under mentor or manager supervision; Supporting vendor selection; Creating of Project specific training curriculum; Reviewing time booking, following up on needed corrections; Reviewing pass – through costs; Cooperating with TMF lead, IPO and eCBL on set up on TMF and sitepay with mentor or manager supervision; Cooperating with Project Data Coordinator to set up system access management process; Working with PL and FLs to ensure project resources are requested in line with project scope; Collecting, distributing and tracking insurances and Letter of Authorization Project Execution and Control: Study reporting and distribution to FLs and project team. Maintaining systems and tools according to applicable SOPs. Project Integration Management : Maintaining consistent coherent project management plans, reviewing plans with PL and distributing to the different functions. Reviewing time booking and overconsumption with FL, collecting input ready for PL review; Reviewing pass – through costs; Reviewing Project Specific Training Compliance and following up on non- compliances; Assisting with preparation and action follow of Project Operational review meetings; Providing reports, metrics and initial analysis for informed Project Leader decision making and client reporting. Maintaining oversight on project system accesses and review. Project Meeting Management: Project meetings preparation and attendance; Supporting preparation of required information for internal and client meetings; Supporting tracking and follow-up of action items. Project Vendor Management: Collaborating with PL and FLs to ensure study supplies are delivered as required and according to contract obligation. Performing vendor invoice review. Project Closure Management: Close out responsibilities are assigned depending on acquired knowledge and independence. Collaborating with PL on ensuring that systems are closed, documents archived, and final work is handed-over to the sponsor Skills: Good verbal and written communication skills, as the exchange of information is a significant part of the job. Developed interpersonal skills and ability to build relationship Attention to detail and quality of work. Client focused approach to work Flexible attitude with respect to work assignments and new learning Ability to manage multiple and varied tasks with enthusiasm Ability to prioritize workload A willingness to work in a matrix environment and to value the importance of teamwork. Basic problem- solving ability. Knowledge and Experience : Relevant basic experience in the PS/ or similar role desirable Basic knowledge of activities and procedures of the work area Good Knowledge of Microsoft based applications Shift: 2:30 PM - 11:30 PM Education: Intermediate to Advanced English level for non-native English speakers Minimum Bachelor’s degree or equivalent degree

Additional Locations India - Hyderabad; Job ID R0000033860 Category Medical Sciences ABOUT THIS ROLE The Drug Safety Associate will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs). Key Accountabilities : Drug Safety Support : Assist in development of project specific safety procedures, workflows and template Assist in project specific safety database setup, development of data entry guidelines, and user acceptance testing Triage incoming reports for completeness, legibility, and validity Electronic documentation and quality control of drug safety information Data entry of case reports into safety database / tracking system Request follow-up and perform query management Coding of data in the safety database Writing case narratives Create and maintain project specific working files, case report files and project central files Assist with additional Drug Safety Specialist and/or Safety Service Project Leader (SSPL) activities as required Inform Line Manager (LM)/Team Manager, Safety Services Project Leader (SSPL) or Project Leader (PL) and Regional Head of PV Operations of potential change-in-scope of projects Support of Medical Directors/Safety Physicians, as needed, in medical monitoring activities Participate in client and investigator meetings as required Attend internal, drug safety and project specific training sessions Perform literature searches Preparation for, participation in, and follow up on audits and inspections Delegate work as appropriate to Drug Safety Assistants Assistance in development of Expedited Reporting Procedures Assistance with registration with relevant authorities for electronic reporting on behalf of sponsor Assistance with setting up and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy) Submission of safety reports to investigators via ISIS (International Safety Information System) Assist with measuring investigative site performance in conducting required tasks in ISIS Tracking and filing of submission cases as required Assist with unblinding of SUSARs, as required Support collection and review of metrics for measuring reporting compliance Skills : Analytical and problem-solving skills Able to perform database/literature searches Excellent interpersonal skills Excellent verbal / written communication skills Excellent organizational and prioritization skills Ability to work collaboratively and effectively in a team environment Client focused approach to work Experience with computer applications Knowledge and Experience : Related experience gained in a healthcare environment is an advantage minimum 1+ years of relevant experience in PV. Experience in PV database like LSMV (LifeSphere Multivigilance) is preferred. Education : Degree in Pharmacy, Nursing, Life Science or other health-related field, or equivalent qualification/work experience Associates degree in any of the above with appropriate work experience

Additional Locations India - Hyderabad; Job ID R0000033860 Category Medical Sciences ABOUT THIS ROLE The Drug Safety Associate will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs). Key Accountabilities : Drug Safety Support : Assist in development of project specific safety procedures, workflows and template Assist in project specific safety database setup, development of data entry guidelines, and user acceptance testing Triage incoming reports for completeness, legibility, and validity Electronic documentation and quality control of drug safety information Data entry of case reports into safety database / tracking system Request follow-up and perform query management Coding of data in the safety database Writing case narratives Create and maintain project specific working files, case report files and project central files Assist with additional Drug Safety Specialist and/or Safety Service Project Leader (SSPL) activities as required Inform Line Manager (LM)/Team Manager, Safety Services Project Leader (SSPL) or Project Leader (PL) and Regional Head of PV Operations of potential change-in-scope of projects Support of Medical Directors/Safety Physicians, as needed, in medical monitoring activities Participate in client and investigator meetings as required Attend internal, drug safety and project specific training sessions Perform literature searches Preparation for, participation in, and follow up on audits and inspections Delegate work as appropriate to Drug Safety Assistants Assistance in development of Expedited Reporting Procedures Assistance with registration with relevant authorities for electronic reporting on behalf of sponsor Assistance with setting up and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy) Submission of safety reports to investigators via ISIS (International Safety Information System) Assist with measuring investigative site performance in conducting required tasks in ISIS Tracking and filing of submission cases as required Assist with unblinding of SUSARs, as required Support collection and review of metrics for measuring reporting compliance Skills : Analytical and problem-solving skills Able to perform database/literature searches Excellent interpersonal skills Excellent verbal / written communication skills Excellent organizational and prioritization skills Ability to work collaboratively and effectively in a team environment Client focused approach to work Experience with computer applications Knowledge and Experience : Related experience gained in a healthcare environment is an advantage minimum 1+ years of relevant experience in PV. Experience in PV database like LSMV (LifeSphere Multivigilance) is preferred. Education : Degree in Pharmacy, Nursing, Life Science or other health-related field, or equivalent qualification/work experience Associates degree in any of the above with appropriate work experience

Knowledge And Skills In-depth knowledge & hands-on experience in Major Incident Management, Change Management & Problem Management Comfortable working closely with technical resources & Team leaders to ensure / maintain globalization strategies. Identify opportunities for improving business operations through more effective use of IT resources. Contribute to the definition and development of worldwide operating procedures and standards. Prepare process proposals or recommendations especially related to improve efficiency and performance of the IT environment. The ability to deliver an initiative through to its launch/implementation. A high level of quality and attention to detail. Experience in service management, process development, IT operations. Excellent interpersonal and customer service skills. In-depth knowledge of industry best practices and service delivery standards. Strong team spirit. Excellent written and verbal communication skills. Excellent organizational skills. Problem-solving skills. Ability to communicate complex business challenges in a non-technical and simplified manner Creation and management of various monitoring dashboards/presentations Evaluated service performance and modified SLA patterns to resolve operational issues Able to work under tight deadlines Self-motivation and able to take responsibility Experience And Education At least ITIL 4 Foundation certified. Experience leading a multicultural, worldwide team. Experience successfully evolving IT processes. BS/BA or relevant work experience. Strong English written and verbal skills required. Play a key role in maintaining and evolving a modern, mature & robust IT Service management function by working closely with the ITSM team as well as other IT groups & value stream owners to enforce & evolve processes. Providing a high level of quality support to the end user community by helping resolve end user/service escalations as well as assisting the business in meeting it goals. Show more Show less