Parexel

Research Analyst

• Responsible for the site management, site monitoring and close-out of assigned clinical trials
• Ensure patient safety and quality study execution
• Manage investigator site relationships for effective delivery of clinical trials
• Safeguard the quality of investigator sites, including patient safety and compliance with GCP
• Resolution of all protocol-related issues for assigned investigator sites
• Work closely with the Site Care Partner, and other members of the study team

Clinical Research Associate / Senior Clinical Research Associate

Manager

• Manage courseware development including course design, publishing, testing, and deployment.
• Provide technical, instructional design, and operational management for programs and be accountable for meeting project commitments.
• Communicate and ensure a global understanding of training strategy and goals.
• Manage deliverables according to endorsed plans and timelines across multi-functional teams including course design, development, and deployment.
• Partner with associated business line and Subject Matter Experts (SMEs) to proactively identify training needs and development and deployment of training programs.
• Advise on processes, monitor activities related to compliance oversight of training programs, and ensure programs and projects are evaluated for effectiveness and customer satisfaction.
• Development of metrics and performance measures, reporting, and analysis to meet business needs and regulatory requirements; budget management for training projects.
• Ensure compliance to training and education regulatory requirements and consistent implementation of best practices, standards, and training globally to support inspection readiness.

Training Development Lead

• Identify, evaluate and respond to GCP quality risks related to vendor and site engagement
• Lead quality discussions with key vendors and sites and present quality point of view at relevant oversight meetings
• Provide quality oversight reports to appropriate sponsor's management / functions
• Communicate key quality information (e.g., inspection / audit learnings) across vendors and site entities and serve as quality expert for third parties
• Validate, monitor and close out GCP-quality-related action plans
• Evaluates quality performance at an enterprise level to inform continuous improvement of quality risk management
• Informs site organization relationship owner of quality improvement considerations
• Support QMS09 BPO in the development and implementation of process updates
• Support Vendor Leads / Business Owners to ensure compliance with functional level vendor oversight requirements

Senior Quality Lead – FSP

• Perform site management activities to ensure compliance with the protocol, monitoring plan, ICH GCP, local regulatory requirements, and sponsor SOPs
• Conduct site qualification, initiation, interim, and close-out visits, both on-site and remotely
• Partner with Clinical Trial Liaison (CTL) and other sponsor functions to support site activation and deliverables
• Establish and maintain productive professional relationships with investigator site staff
• Perform drug accountability, reconciliation, and destruction, ensuring protocol compliance
• Prepare and maintain Oversight Monitoring Plan
• Conduct Oversight Monitoring Visits at sites
• Review and report on status of study conduct at the investigator site
• Ensure site regulatory files are current and timely submission of study documentation
• Identify and record protocol deviations, escalate non-compliance, and resolve study-related issues
• Maintain ongoing communication with site personnel, study teams, and other stakeholders
• Support inspection readiness activities and ensure data integrity and protocol deliverables

Senior Clinical Research Associate – FSP

Compliance

• Contribute to preparation and delivery of regulatory submissions from a global and regional perspective
• Preparation and review of Marketing Authorization Applications & Variations for filing

Senior Regulatory Affairs Associate – CMC Biologics

Financial Planning and Analysis

• Create accurate, transparent, and timely financial analysis to support project leadership in project decision making process; clearly articulate financial implications of business decisions and provide retrospective analysis as well as drive forward looking actions on simpler projects / contract types.
• Facilitate the monthly revenue cycle and support project analysis requirements, including a review of units, forecast, unit prices, and revenue recognition.
• Complete all required variance analyses for the set of projects, with insight.
• Identify risks in the project forecast and opportunities to improve revenue outlook.
• Communicate, document, and manage these on an ongoing message.
• Understand alternative finance scenarios within a project with a degree of technical knowledge and business acumen.
• Provide updates on financial status for assigned projects and create information in response to any client financial reporting needs for assigned projects in the area of project reporting, forecasting, or transactional details for the projects within the portfolio.
• Actively monitor the balance sheet positions of projects within the portfolio. Initiate action as needed with project teams to keep balances current, improving DSO and cash flow.

Financial Analyst II

Project Manager

• Lead Parexel and Sponsor teams by leveraging clinical research experience and project management skills
• Ensure operational excellence and successful execution of clinical operations and logistical strategies for EP clinical trials or programs
• Manage the financial aspects of projects, including revenue recognition, milestone payments, and monthly pass-through invoices
• Own the sponsor relationship and manage sponsor communication
• Serve as the central point of contact and escalation for functional teams
• Communicate project progress, risks, and solutions to sponsors and internal teams
• Manage study start-up activities and ensure best practices are implemented
• Monitor study timelines, recruitment, retention, and data cleaning
• Oversee administrative closeout procedures and ensure project documentation is archived

Project Manager – Early Phase

Clinical Operations

• Support activities related to study/site feasibility, start-up, maintenance, and close-out
• Manage study and site essential document review, collection, tracking, etc. from study start-up through maintenance and close-out
• With guidance, support the Study Lead (CTM, AD, etc.) to prepare and maintain study documents and manuals as applicable
• Study Trial Master File oversight, review and filing
• Organise study related meetings including but not limited to preparation of agenda/ minute taking and maintenance of risk/ issue/ decision logs
• May perform applicable site monitoring / co-monitoring visits (ad hoc, pre-study, initiation, routine monitoring close-out visits)
• Provides rapid action to address both internal and site QA findings from audits
• May manage, coordinate, and oversee the activities from third party vendors including deliverables metrics, accruals, process planning, and implementation
• General study tracking and maintenance and study site oversight including but not limited to site performance, metrics, monitoring report review, etc.
• Assist and support study data related activities including data review, query creation and resolution, study and protocol deviation reviews, safety reviews, etc.
• Routinely support and participate in department and clinical trial team meetings and participate in collaborative efforts (e.g., protocol development, CRO selection, departmental initiatives, etc.)
• Review and verification of contracted vendor activities including vendor invoice review

Associate Clinical Operations Leader – Clinical Trial Specialist

• Contributes to the selection of potential investigators
• In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance
• Trains, supports, and advises Investigators and site staff in study related matters
• Ensures the sites are inspection ready at all times
• Actively participates in Local Study Team (LST) meetings
• Drives performance at the sites
• Updates CTMS and other systems with data from study sites as per required timelines
• Performs monitoring visits (remote and onsite)
• Ensures data query resolution in a timely manner
• Supports/participates in regular QC checks performed by LSAD or delegate
• Ensures compliance with client ’s Code of Ethics, company policies and procedures

Clinical Research Associate – FSP

• Coordinate the preparation, compilation, and submission of new drug applications and Lifecycle Manage (LCM) activities
• Organize the submission team meetings (“Kickoff Meeting”)
• Facilitate effective communication among all stakeholders including CMC, labelling, RRL, Local Regulatory Responsible (LRR) or Regulatory Partner Representative (RPR)
• Prepare the Submission Content Plan (SCP) based on country-specific regulatory requirements
• Support the M1 documents preparation
• Ensure appropriate archiving of labeling documentation
• Track the dispatched documentation for each country
• Proactively identify potential project issues, risks, and roadblocks that may impact submission timelines

Regulatory Affairs Consultant – Regional Submission Coordinator

Operations

• Supports Global Study Managers (GSMs) and other Study Operations Managers (SOMs) to deliver study management by leading specific parts of projects
• Oversees the preferred Contract Research Organization (pCRO) at country level and manages country level plans
• Liaises with Site Care Partners (SCP) and regulatory colleagues to agree on submission strategy to Health Authorities (HAs)
• Collaborates to identify and manage deviations and risks in study startup and execution
• Ensures compliance to relevant global and local, internal and external requirements, and regulations

Country Study Operations Manager

• Provide GCP compliance support to clinical study teams under the direction of the Sr. Manager or the Associate Director.
• Develop strong relationships with R&D personnel across functions and teams providing coaching and compliance guidance as needed.
• Collaborate with stakeholders in conducting ongoing risk assessment of clinical trial activity to identify priority studies, compliance metrics for tracking, high-risk vendors, and key compliance activities (i.e., protocol review, vendor evaluations, inspection readiness).
• Identify and escalate significant quality and compliance issues to the Head of Clinical Quality & Compliance and relevant leadership, including the assessment of serious breaches.
• Participate as a member of Contract Research Organization (CRO)/Vendor governance teams for assigned Therapeutic Areas/Studies.
• Establish a relationship with CRO Quality Team members for the ongoing review of quality and compliance issues.

Clinical Compliance Manager – FSP

• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality
• Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
• Serve as the primary point of contact for assigned investigator sites during study conduct
• Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators
• Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit

Senior Clinical Research Associate, All Levels

• Provide leadership and direction to the trial team and is accountable for the overall success and delivery of their assigned clinical trial according to defined milestones and KPI’s.
• Responsible for steering and directing clinical trial activities, including patient and site engagement activities, direct communication and interaction with multiple internal and external stakeholders, and team members on a global, multi country or regional basis.
• Accountable for the accurate planning and operational feasibility of trial timelines; and oversight of trial preparation to ensure trial team members are aligned and on track.
• Supports development of trial level documents owned by other functions (e.g. Statistics, Data Management, Study Physician, Medical Writing, Site Monitoring).
• Verifies and provides input into the country allocation and oversees trial feasibility.
• Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring/mitigation.
• In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, SMC/DMC management and safety reporting.
• Prepares and implements amendments of core documents, including training material updates/retraining as needed.
• Supports authority/ethics response to requests as applicable.
• Collaborates with other functions, ensuring timely cleaning and delivery of clinical trial data.
• Coordinates and supports trial medical writer in providing the CTR.
• Responding for timely, complete and compliant archiving of all relevant global documents in the TMF, including all required documents from vendors.
• Supports results/documents disclosure of global registries.

Global Study Manager II

• Provide leadership and direction to the trial team
• Accountable for the overall success and delivery of their assigned clinical trial according to defined milestones and KPI’s
• Responsible for steering and directing clinical trial activities
• Direct communication and interaction with multiple internal and external stakeholders
• Ensure trial team members are aligned and on track for trial timelines
• Supports development of trial level documents owned by other functions
• Verifies and provides input into the country allocation and oversees trial feasibility
• Maintains oversight during clinical trial conduct including adherence to GCP and all regulatory requirements
• Ensures budget oversight in collaboration with other functions
• Prepare and implement amendments of core documents
• Support authority/ethics response as applicable
• Ensures timely cleaning and delivery of clinical trial data
• Coordinates and supports trial medical writer in providing the CTR
• Responding for timely, complete and compliant archiving of all relevant global documents