Parexel

Software Engineer

• The Principal Clinical Database Programmer will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors
• Lead and supervise and/or create, implement and execute procedures to build and maintain database set-up for paper-based and/or web-based (EDC) clinical data management systems (CDMS)
• Set-Up, Maintain, Revise, Close-Out Electronic Data Capture Systems
• Provide feedback for study programmers on the creation of eCRF’s following SOPs and internal process guidelines
• Coordinate and lead a programming team to successful completion of a study within given timelines and budget
• Interact with Sponsors and Data Management Leaders as the key contact regarding programming related issues
• Maintain all supporting documentation for studies in accordance with SOPs/Guidelines/Work Instructions to ensure traceability and regulatory compliance
• Act as a mentor and/or SME providing, creating and implementing relevant training for staff.

Principal Clinical Database Programmer

• Provide technical expertise for the conduct of clinical trials
• Act as an internal subject matter expert in specific areas providing technical support and expert advice
• Work independently to support various programming activities related to clinical systems, and/or the applications/systems within eClinical technologies
• Assist with the Database Primary or Technical Lead role on projects
• Liaise with sponsors, Data Management Lead and other functional areas as required
• Lead and supervise and/or create, implement and execute procedures to build and maintain database set-up for paper-based and/or web-based (EDC) clinical data management systems (CDMS)
• Ensure that timelines are adhered to
• Monitor project resourcing and identify changes in scope
• Ensure first time quality on all deliverables

Senior Clinical Database Programmer

• Provide technical expertise for the conduct of clinical trials
• Support various programming activities related to clinical systems
• Setup databases for clinical data management systems
• Ensure adherence to service level agreements
• Maintain supporting documentation for studies
• Participate in the creation of standards as required for GDO

Clinical Database Programmer II

Research Analyst

• You will be dedicated to a single client.
• You will be responsible for all site management and supervisory activities in the assigned oncology studies.
• You will work with industry leaders and subject matter experts.
• You will have the opportunity to mentor junior CRAs.
• You will work with world-class technology.
• You will have great opportunities to travel, work from home, meet new people and play a key role in the drug development process.

Clinical Research Associate – FSP

Financial Planning and Analysis

• Supports the Clinical Research Manager (CRM) and other team members through the life cycle of the study from study start up to study closure.
• Trial and site administration: Tracking (e.g., essential documents) and reporting (e.g., Safety Reports).
• Ensure collation and distribution of study tools and documents.
• Update clinical trial databases (CTMS) and trackers.
• Clinical supply & non‐clinical supply management, in collaboration with other country roles.
• Manage Labeling requirements and coordinate/sign translation change request.
• Document management: Prepare documents and correspondence.
• Collate, distribute/ship, and archive clinical documents.
• Assist with electronic Trial Master File (eTMF) reconciliation.
• Updating manuals/documents (e.g., patient diaries, instructions).
• Document proper destruction of clinical supplies.
• Prepare Investigator trial file binders.
• Execute eTMF Quality Control Plan.
• Obtain translations of documents.
• Regulatory & Site Start Up responsibilities: Provide to and collect from investigators forms/lists for site evaluation/validation, site start‐up and submissions in a timely manner.
• Obtain, track and update study insurance certificates.
• Support preparation of submission package for Institutional Review Board (IRB) / Ethics Review Committee (ERC) and support regulatory agencies submissions.
• Publish study results for Global Clinical Trial Operations (GCTO) and Regulatory Affairs (RA) where required per local legislation.
• Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives for: Development of country and site budgets (including Split site budget).
• Tracking and reporting of negotiations.
• Maintenance of tracking tools.
• Working knowledge of contract development, negotiation, approval, and maintenance (e.g., Clinical Trial Research Agreements (CTRAs)).
• Updating and maintenance of contract templates (in cooperation with Legal Department).
• Payment calculation and execution (investigators, vendors, grants.
• Ensuring compliance with financial procedures.
• Monitoring and tracking adherence and disclosures.
• Budget closeout.
• Obtain and process Foreign Corrupt Practices Act (FCPA) documentation in a timely manner.
• Meeting Planning: Organize meetings (create & track study memos/letters/protocols).
• Support local investigator meetings (invitations, prepare materials, select venue, support where applicable).
• Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training.
• Adheres to EP and Client SOPs and processes.

Clinical Trial Coordinator – Finance

Compliance

• Manage import and export operations in Chile and other Latin American countries
• Ensure compliance with customs regulations while supporting critical clinical research projects
• Build relationships with customs brokers and government agencies
• Maintain documentation in compliance with Parexel and local regulatory requirements
• Design and implement operational and compliance procedures
• Serve as the primary interface with customs brokers and logistics providers
• Prepare and submit import/export license applications
• Attend project meetings to provide updates and resolve issues
• Track and manage import/export licenses

Global Trade Compliance Coordinator

Recruitment

• Lead the development of program and study-level patient recruitment and retention strategies
• Provide strategic input into protocol and operational planning to identify enrolment opportunities, recruitment risks, and retention challenges
• Drive execution of recruitment and retention activities against agreed timelines, budget, and enrolment objectives
• Provide oversight of CROs and specialist vendors supporting patient recruitment and retention activities
• Contribute to the enhancement of recruitment tools, methodologies, and best practices across the clinical development portfolio

Patient Recruitment Manager

General

• Support project setup, planning, scheduling, and resource management activities
• Maintain project plans, schedules, trackers, and project documentation
• Prepare project reports, dashboards, and meeting materials
• Coordinate project meetings, distribute agendas, capture minutes, and track action items
• Monitor project progress and highlight risks or issues to stakeholders
• Assist with project financial tracking, timesheet reviews, and invoice processing
• Ensure proper document management, project closeout, and archival activities

Project Specialist

Solutions Engineer

• Design and develop systems and data integrations using MuleSoft Anypoint Platform.
• Design and develop high-quality APIs and Integrations.
• Develops unit tests and provides code coverage to accurately testing business logic and functionality.
• Creates high-level design documents, including MuleSoft functionality.
• Support and fine-tune existing integration architecture and code to improve performance, processes, and best practices.
• Solves or recommends solutions for complex issues and problems.
• Actively engages in improving software delivery through DevOps and other Agile practices.
• Participate in and lead code reviews.
• Collaborate extensively with vendor partners, as well as internal Parexel teams to deliver high-quality solutions.
• Stay current on industry best practices as well as other emerging technologies.

Senior Integration Engineer

Consultant

• Support delivery of Literature Review projects
• Lead specific components of evidence evaluation projects
• Provide insights for decision-making in healthcare policy and market access
• Manage small-scale projects and mentor junior team members
• Contribute to client communications and presentations

Health Economics Consultant

• Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports.
• Assess change controls and provide regulatory assessments of quality changes in production and quality control.
• Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.
• Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.
• Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
• Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.
• Identify, escalate, and mitigate risks associated with regulatory procedures and activities.

Senior Regulatory Affairs Associate – CMC Biologics, Vaccines

• Develop the site start up strategy for each study, outlining all dependencies impacting site activation
• Oversee the tracking and analysis of study metrics, including risks and mitigation strategies
• Advocate for optimized site selection strategies, leveraging data-driven insights
• Lead the development, assessment, and alignment of site activation projections
• Ensure comprehensive and compliant documentation of site start-up materials in the Trial Master File (TMF)
• Partner with cross functional and CRO partners to develop a comprehensive global country start up strategy
• Monitor and maintain country intelligence data to support informed decision-making
• Support regulatory submissions as needed
• Lead and oversee all aspects of site start-up activities
• Serve as the subject matter expert for essential site documents
• Oversee the collection and analysis of site intelligence to support strategic site selection and site start-up
• Represent SSU on cross-functional teams

Global Site Start Up Lead

Clinical Research

• Oversight of activities
• Evaluate the intent of the study concept and make informed recommendations based on scientific review
• Effectively communicate with key stakeholders through the initial viability/feasibility concept phase
• Utilize tools (e.g. Medidata, Symphony) to generate data to satisfy feasibility/viability requests
• Author reports to inform project teams of assessments
• Collaborate with cross-functional teams to evaluate study concepts and deliver comprehensive feasibility reports

Senior Manager, Feasibility

Contracts Specialist

• Amend, negotiate and finalise project budgets together with creating draft contractual documents
• Prepare draft contract documents, including Start-up Agreements, Work Orders and Change Orders
• Amend project budgets as required
• Direct client interaction with established contacts
• Provide quality client deliverables to strict deadlines
• Facilitate review and approval in accordance with relevant policies and procedures
• Cooperation with Finance on ongoing budget changes
• Participate in contract review meetings with clients and internal customers
• Review client contractual templates with support from Line Manager/Contracts Director/LRM

Contracts Specialist – Budget Focus

Associate

• Responsible for negotiation with sites, finalization, and execution of all types of site contracts required for site activation including budget negotiations
• Manage the negotiation, finalization, and execution of any amendments to the original contracts post site activation
• Ensure the highest standard of quality of final documents and compliance with relevant regulatory requirements including ICH – GCP
• Ensure that contracts meet needs of both clients and clinical trial sites, protecting best interests of clients and the company while nurturing positive relationships with clinical trial sites