Parexel

Software Engineer

• Effectively designs and codes R and SQL programs for assigned project(s)
• Clean and validate RWD for consistency and reliability
• Implement programming as specified from RWE protocol
• Create or review and approve programming plans at study and project level
• Maintain clear documentation of analytical programming and operational definitions
• Develop dashboards, reports, and presentations to communicate findings
• Collaborate with members of study teams to meet study and recurring report timelines

Senior RWE Programmer

General

• Lead and manage medium to high complexity clinical trials or low complexity clinical trial programs
• Develop and maintain comprehensive project plans with key milestones, budgets, and resources
• Own the client relationship at the study level, establishing effective communication channels
• Manage project profitability through budget oversight, revenue recognition, forecasting
• Identify and mitigate project risks, implement contingency plans

Senior Project Leader

Affiliate Manager

• Support site initiation, monitoring, and closeout activities to ensure compliance with protocol requirements and regulatory standards
• Maintain and organize study documentation, including regulatory files, correspondence, and study records
• Assist with patient recruitment, enrollment, and informed consent processes while maintaining ethical standards
• Support data collection and verification activities to ensure accuracy and completeness of clinical trial data
• Coordinate with site personnel, sponsors, and internal teams to address study-related issues and maintain effective communication
• Monitor adherence to Good Clinical Practice (GCP) guidelines and regulatory requirements throughout the study lifecycle
• Prepare reports and documentation required for regulatory submissions and study audits
• Contribute to continuous improvement initiatives and share best practices across the clinical research team.

Site Care Partner

Research Analyst

• Oversight of Monitoring Responsibilities and Study Conduct
• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable laws
• Manage operational aspects for clinical trial activities at assigned investigator sites
• Serve as the primary point of contact for assigned investigator sites
• Conduct onsite, remote/electronic monitoring as needed

Clinical Research Associate II – Senior

Compliance

• Provide leadership and direction to consultants, senior consultants and managers
• Act as the Subject Matter Expert (SME) for EU Clinical Trials Regulation (EU CTR)
• Drive capability building through coaching and mentoring
• Support regulatory audits and inspections
• Deliver regulatory consultancy and client-focused guidance

Senior Manager, Regulatory Affairs

Manager

• Leads operational activities related to study planning, study execution, and the summarization of results from observational research studies
• Coordinates the end-to-end process for executing observational or non-interventional research studies in compliance with GPP and SOPs
• Plans, initiates, executes, and closes out primary data collection, chart review, database, and molecular epidemiology studies
• Collaborates with colleagues in GMSA to support lead scientists in overall operational support for study conduct
• Provides study-level management support including the execution of appropriate services for approved proposals/scopes of work
• Participates in protocol and interim/final report preparation and literature review abstraction

Non-Interventional Study Research Manager

• Partners with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development and completion of relative associated documentation as required.
• Lead and attends relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities.
• Support and lead global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
• Manages the compilation for core package build, contributing to CTA and authoring documentation as required.
• Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.

Regulatory Affairs Consultant – CTA

• Implement comprehensive regulatory strategies for clinical trials in Mexico
• Prepare, review, and submit regulatory dossiers to COFEPRIS and Ethics Committees
• Manage the complete regulatory submission process under the new simplification agreement
• Utilize the DIGIPRIS platform for regulatory procedures and tracking
• Prepare high-quality technical responses to COFEPRIS requirements
• Maintain effective communication with regulatory authorities and ethics committees
• Provide expert regulatory guidance to internal teams and clients
• Monitor changes in Mexican regulations and assess their impact on projects
• Ensure compliance with timelines and quality standards for all deliverables
• Collaborate with global and local teams in the execution of clinical studies

Regulatory Affairs Associate – Clinical Trials Submissions

Clinical Trial Associate

• Provides logistical support to one or more global study management teams (SMT)
• Develops and maintains effective working relationships with SMT members, affiliate team members, and vendors
• Assists Clinical Trial Manager (CTM) with effective communication between the SMT and Affiliates
• Coordinates the management of all global supplies utilizing the designated systems in collaboration with the CTM throughout the course of the study
• Coordinates and organizes study related meetings in collaboration with the Clinical Program Leader (CPL) and CTM including the development and production of presentation materials
• Consolidates study information for study trackers and databases
• Supports the protocol feasibility, country, and site selection process
• Supports CTM in technical and logistical study processes
• Tracks and maintains study information and documentation and reports on study progress
• Maintains accurate tracking and reporting of Study Management data
• Coordinates and maintains the contact details of core SMT and Clinical Operations teams, including country contacts and distribution lists
• Oversees the timely tracking of Health Authority (HA)/IRB/IEC submissions and approvals in CTMS
• Identifies any delays and raises issues to the CTM and appropriate Country Study Manager (CSM)
• Provides IRB/IEC and HA submission documentation and all other supplementary documentation to affiliates or Product Development Regulatory (PDR), as appropriate
• Maintains and ensures the completeness of the Study-Level Trial Master File (TMF) in accordance with SOP requirements under the direction of the CTM
• Identifies and contributes to areas of best practice and process improvements
• Proactively incorporates learnings and recommendations from other study debriefs and best practices
• Organizes agendas and minutes for team meetings
• Manages touchpoint study area according to global standards, including set-up, access rights, and maintenance of study-related documents
• Manages client system platform access rights and follows up on site training progress
• Ensures appropriate tracking and dissemination of Safety Reports during studies
• Assists in the coordination of activities to ensure CRO and vendor delivery against the contracted scope of work
• Coordinates communication for defined tasks and tracking information between the study team and vendor
• Complies with all required training curricula
• Completes timesheets accurately as required
• Submits expense reports as required
• Updates CV as required

Senior Clinical Trial Associate

• 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

• 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

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