Parexel

Financial Planning and Analysis

• Relationship Management: Work alongside project team to help develop a partnership with all Parexel departments.
• Project Management: Provide support with quality review, audits, and ongoing maintenance of SOPs.
• Financial Management Budget Pricing/Development: Participate in budget briefing meetings.
• Contracting: Working alongside MedCom account leads/Customer Strategy Directors to support the set-up of new Clients.
• Business Development Support: Work with the Account Manager/Manager/Director/VP to support business opportunities for MedCom.

Budgeting and Analysis Specialist

Software Engineer

• Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures
• Perform programming validation to ensure quality of analysis datasets and programming outputs
• Provide programming support for project teams, including development of programming strategies, standards, specifications, and programmed analysis
• Support the electronic submission preparation and review
• Review key planning documents to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements
• Interact with vendors regarding project standards, programming conventions, programming specifications and file transfers
• Provide leadership for ensuring quality of deliverables by consistently applying standards and complying with regulatory requirements
• Identify opportunities for increased efficiency and consistency within team and interactions with strategic vendors
• Independently lead and perform programming assignments with minimal supervision
• Support improvement initiatives.

Senior Statistical Programmer – FSP

Pharmacist

• Coordinate with the EPCU Pharmacist or pharmacy technicians to support timely review of IP (Investigational Product) randomization schedules, dose preparation requirements, and other project-related work.
• Ensure sufficient inventory of test and reference products to support ongoing study execution.
• Store IP according to study protocols, EPCU SOPs, and applicable regulatory guidelines.
• Prepare, label, and dispense IP for dosing in strict compliance with protocols, randomization schedules, EPCU SOPs, and regulatory requirements.
• Ensure timely and accurate delivery or availability of IP for all dosing activities.
• Maintain accurate and complete documentation of IP receipt, preparation, dispensing, returns, and destruction or return to the Sponsor.
• Oversee proper storage, archiving, and maintenance of IP study documentation.
• Ensure that IP is securely stored in designated locked areas within the EPCU.
• Comply with EPCU SOPs, Good Clinical Practices (GCP), and Good Pharmacy Practices.
• Participate in project or client meetings to represent EPCU Pharmacy services, as applicable.
• Support sponsor monitoring visits related to IP accountability and documentation.
• Assist in maintaining and improving pharmacy workflows and operational processes.
• Participate in quality improvement initiatives within the EPCU.
• Perform other pharmacy-related duties as assigned.

Pharmacy Technician – Per Diem

Manager

• The Clinical Laboratory Study Manager works with Precision Medicine Strategy Lead as well as clinical study teams, data management (DM) team, Samples, Kits, Data, Logistics (SKDL) and Clinical Laboratory Project Management (CLPM) groups to ensure quality samples and data are delivered to support biomarker and non-biomarker evaluation and enable the translation of science to medicine.
• Responsibilities include oversight of clinical sample collection, usage per informed consent form, sample tracking (chain of custody), management of central laboratory and specialty vendors and sample destruction.
• Individual will work closely with internal and external groups/vendors to manage and support the generation of quality laboratory data.
• Will work closely with project managers (central and/or specialty labs) and lend expertise to clinical trial management (CTM) and CRO to ensure samples are collected per protocol and assist with resolving any sample related issues or queries. Additional responsibilities include overall project management in alignment with the core business strategy.

Clinical Laboratory Study Manager – FSP

Compliance

• Lead, facilitate and support the risk management process for assigned projects/Partnership/accounts using the available tools.
• Work with other RCLs to oversee and direct the risk management process across multiple projects within the account.
• Lead cross-functional teams, functional leaders, and subject matter experts (SMEs) in identifying, prioritizing, and mitigating risks, embedding solutions into project strategies.
• Evaluate and refine mitigation effectiveness, driving continuous improvement in risk management practices.
• Establish best practices for documenting and disseminating lessons learned, fostering a culture of knowledge-sharing.
• Provide expert guidance to other RCLs and serve as a resource for resolving escalated risk challenges.
• Lead proactive analysis of key risk indicators and signals across projects and accounts, through Quality Risk Evaluations (QRE), leveraging dashboards, metrics and predictive tools.
• Synthesize complex data into actionable insights, presenting high-level risk assessments and recommendations to project teams and leadership.
• Direct the development and implementation of mitigation strategies, ensuring their long-term success and alignment with organizational goals.
• Mentor other RCLs on QRE process and consult leadership on escalated risks.
• Serve as SME for QRE as assigned by LM. Serve as a senior consultant on complex consultancy requests and SOP deviations.
• Provide strategic, real-time advice to project teams and leadership to ensure first-time quality and resolve high-impact challenges.
• Lead investigations into project-level SOP deviations (across projects and accounts), collaborating with SMEs to recommend solutions.
• Partner with project teams to sustain an audit/inspection-ready state, providing advanced oversight of storyboards and documentation practices.
• Assist with audit and inspection preparations, including prioritizing tasks and reviewing critical documents.
• Coach teams on maintaining audit/inspection readiness as a proactive, ongoing priority.
• Proactively identify gaps in documentation encouraging project teams to document via project-level story boards where applicable.
• Provide senior-level support during audits/inspections, may be required to host audit/inspection and manage high-stakes engagements with confidence and expertise.
• Serve as the Quality Representative for Quality Event (QE) – Quality Issues and Audit/Inspection Findings.
• Triage quality issues in electronic quality management system (eQMS) setting standards for accuracy and consistency.
• Support in the initial assessment of Serious Breach of GCP and coordinate swift and effective containment strategies with the QE team.
• Drive Root Cause Analysis (RCA) efforts with established methodologies, ensuring the development and execution of impactful Corrective and Preventive Actions (CAPAs).
• Assess and enhance CAPA effectiveness, providing strategic direction to optimize quality outcome.
• Review and refine audit/inspection responses prior to final QA submission ensuring alignment with quality standards.
• Mentor other RCLs on audit/inspection excellence as Quality Representative.
• Exemplify adherence to company standards, ensuring timely completion of training, timesheets, expense reports, and CV updates per SOPs.
• Maintain rigorous compliance with ICH-GCP, company processes, and global regulatory requirements. Ensure seamless continuity of responsibilities during absences, coordinating with leadership for oversight.
• Mentor other RCLs and serve as an integration partner to facilitate induction into the CDRCM team.
• Build and maintain strategic relationships with internal and external stakeholders, including senior client representatives and third-party vendors, to align risk and compliance priorities.

Clinical Development Risk & Compliance Manager

Medical writer

• Leads or contributes independently to the preparation and compilation of both scheduled and ad-hoc aggregate safety reports.
• Independently performs signal detection activities by collecting and analyzing data from various sources.
• Manages client interactions effectively; handles routine queries independently while escalating complex issues.
• Applies knowledge of global regulatory requirements to ensure timely, high-quality deliverables through robust quality control.

Medical Writer I, Patient Safety

• Leads or contributes to the preparation and compilation of aggregate safety reports.
• Reviews and finalizes safety documents for accuracy and compliance.
• Coordinates submissions to regulatory authorities.
• Conducts literature searches and systematic reviews.
• Identifies complex data discrepancies.
• Supports development of Risk Management Plans.
• Actively contributes to safety strategy discussions.
• Serves as primary client liaison for projects.
• Monitors KPIs and SLAs for assigned deliverables.
• Mentors junior team members by providing training.

Medical Writer – Patient Safety

• Leads the preparation of complex scheduled and unscheduled aggregate safety reports across multiple product types and regulatory regions.
• Develops strategic approaches for challenging safety submissions.
• Reviews and approves high-complexity safety documents.
• Manages meeting logistics including scheduling, agenda drafting, and minute preparation.
• Designs and implements advanced signal detection plans tailored to specific product profiles.
• Leads signal detection for priority products by conducting expert-level analyses.
• Authors and reviews high-priority signal assessment reports and health authority response documents.
• Prepares and handles reviews of health authority response documents.
• Collaborates with cross-functional teams to ensure RMPs are scientifically robust and compliant.
• Demonstrates deep expertise in safety profiles across a wide range of therapeutic areas.

Senior Medical Writer, Patient Safety

• Independently lead the preparation/update of complex aggregate safety reports across multiple product types
• Manage the distribution of final reports to stakeholders, including partners and health authorities
• Leads advanced safety signal detection and management for key products
• Collaborates with cross-functional teams to analyze complex safety data
• Provides strategic scientific expertise across therapeutic areas

Principal Medical Writer, Patient Safety

• Adapt global templates of agreements to local use in accordance with local requirements and SOPs.
• Develop and negotiate clinical site budgets based on Fair Market Value.
• Negotiate agreement language and budget with clinical study sites.
• Act as point of contact and interface with Legal if necessary to ensure integrity of contracts.
• For each agreement maintain the status of agreement, budgets, issues, payments, any amendments for the duration of the study, and communications with internal and external sources.
• Ensure final contract documents are consistent with agreements reached at negotiations.
• Ensure all agreements are executed in a timely manner contributing to efficient site start-up timelines.
• Support internal and external audits activities.
• Ensure compliance with client’s Code of Conduct and company policies and procedures relating to people, finance, technology and security.
• Ensure that all contracts are included in the TMF.

Senior Study Contract Manager - FSP

Research Analyst

• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable laws, Good Clinical Practices
• Manage operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through database lock
• Interface with the study team, facilitate information flow between team members and vendors
• Monitor site level AEs and SAEs, collaborate with Drug Safety Unit and follow-up with investigators

Senior Clinical Research Associate – Oncology

SDET

• Support quality control of functional or cross-functional systems in line with Parexel's strategies
• Manage selection/creation of relevant testing scenarios
• Conduct Software Quality reviews of functional requirements
• Write and execute functional & non-functional test plans/cases within an agile environment
• Test software to ensure compliance with SOPs, regulatory requirements
• Create test cases, traceability records, and regression test packs
• Analyze bugs and errors, document the results, and track defects
• Collaborate with stakeholders to report on progress and system quality

Software Quality and Test Engineer

Full-stack Engineer

• Apply data analysis, data modeling, and quality assurance techniques based upon a detailed understanding of business processes.
• Develop and maintain specialist knowledge of database concepts, object and data modeling techniques and design principles.
• Design, code, test, correct and document complex programs and scripts from agreed specifications.
• Design and develop ETL mappings and workflows using Qlik or Informatica.
• Mentor and provide technical guidance for Software Engineers.
• Support technical consulting activities to clients in the pharmaceutical industry.
• Provide application support for existing products.

Senior Software Engineer

Project Manager

• Responsible for defining, developing and delivering the global study start up project strategy
• Manage and coordinate study start up activities globally
• Lead start up sub team for the study, region(s) or countries assigned
• Deliver site activations to plan for studies across high operational complexity
• Accountable for quality and completeness of start up timeline plans at study, country and site level

Start Up Project Manager II

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