Parexel

Affiliate Manager

• Ensuring that sites receive necessary support and engagement issues are resolved
• Being the main client's point of contact for investigative sites
• Accountable for site start-up activities through activation
• Building and retaining investigator site relationships
• Providing support from site recommendation through the lifecycle of studies
• Safeguarding the quality and patient safety at the investigator site
• Contributing to country and site selection activities by proactively collaborating with key stakeholders

Site Care Partner

• Prepare and support the annual federal, state, and local corporate income tax returns
• Assist with quarterly estimated payments and extensions
• Assist with the preparation, filing, and review of sales and use tax, gross receipts tax, and property tax returns
• Monitor changes in indirect tax rules and assess implications for the business
• Prepare components of the quarterly and annual income tax provision in accordance with ASC 740
• Assist with the calculation of current and deferred tax assets and liabilities
• Prepare documentation for external auditors related to income tax accounts and supporting schedules

Senior Tax Analyst

Manager

• Accountable for the end-to-end clinical trial delivery
• Provide operational leadership and oversight of cross-functional deliverables
• Lead a cross functional trial team to build and deliver the trial operational plan
• Identify and mitigate risks to effectively deliver assigned trials on time, within budget, and in a compliant manner
• Influence and execute delivery of the operational plan and for end-to-end trial execution
• Accountable for overall trial delivery, budget, timelines, quality, and milestones
• Oversight of all aspects of CRO/vendor identification, set up, statement of work creation, budget oversight and performance
• Proactively ensure that trial deliverables and milestones are met
• Ensure trial is operationalized in compliance with global health authority regulations and guidelines
• Mentor & support onboarding of new team members
• Provide variance analysis of budget to actual and notify finance of projected cost over/under expenditure

Senior Manager, Clinical Trial Management

• Leading or supporting operational activities from start-up to close-out for assigned studies and investigator sites
• Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for sites initiation
• Provide support to resolve issues or concerns and timely escalation of Site issues where applicable
• Manage and coordinate with other supporting roles to ensure timely site activation and operational activities
• Collaborate with in country regulatory group, and provide related/applicable site documents, as well as in countries where parallel submissions (Regulatory authority and ethics) are required
• Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines
• Identify and resolve investigator site issues

Site Activation Partner

Clinical Research

• Operational Execution of derived datasets and both simple and advanced statistical outputs
• Understand and apply moderately advanced statistical methods
• Coordinate and lead a project team to successful completion of a project within given timelines and budget
• Interact with clients as key contact with regard to statistical and contractual issues
• Assist in the production of analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents
• Check own work in an ongoing manner to ensure first-time quality
• Provide training in statistical analysis to internal clients
• Proactively participate in and/or lead process/quality improvement initiatives
• Travel to, attend and actively contribute to all kind of client meetings as appropriate

Biostatistician II

Operations

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Study Operations Manager – FSP

Conversion Rate Optimizer

• Amend, negotiate and finalize project budgets
• Support change in scopes
• Work on contract development with established templates
• Prepare and finalize draft contract documents
• Provide quality client deliverables to strict deadlines
• Facilitate review and approval of contractual documents and budgets
• Communicate ongoing budget changes

CRO Pricing and Contracts Specialist

Human Resources

• Independently design and implement strategic HR solutions that support business objectives
• Act as a trusted consultant to leaders across regions
• Provide expertise in employee relations, organizational effectiveness, and talent development
• Partner with Talent Acquisition to attract and select top talent
• Lead global, regional, or country-level HR projects
• Mentor HR colleagues and contribute to a collaborative, high-performance HR environment

Senior Human Resources Business Partner

Data Engineer

• Monitor and manage Databricks workspaces across Dev, QA, and Prod environments
• Troubleshoot job failures, cluster performance issues, and workspace-level errors
• Understand design concepts and architectural fundamentals
• Follow and support CI/CD processes for deployments and automation
• Translate functional and non-functional requirements into actionable system specifications
• Develop and maintain complex scripts/applications as needed for platform operations
• Create test cases, scenarios, and validation steps based on specifications
• Apply solid knowledge of SDLC and Agile methodologies
• Stay current with the latest technologies, tools, and industry trends
• Apply strong logical thinking, analytical reasoning, and problem‑solving skills
• Collaborate effectively with cross-functional and distributed teams
• Maintain general working knowledge of Azure DevOps and related operational processes
• Execute quality processes, estimation methods, and documentation activities
• Maintain fundamental understanding of the project domain and data lifecycle

Senior Azure Data Engineer

• Manage external vendors and contract research organizations
• Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual
• Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents
• Assist with protocol development and study report completion
• Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols
• Provide guidance, direction, and management to CRAs
• Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities
• Coordinate study supplies
• Negotiate contracts with vendors of clinical trial services
• Review Informed Consent Forms, CRFs, and study related materials
• Plan and participate in investigator meetings
• Assist and support data query process
• Assure regulatory compliance of investigational sites with the Pharmaceuticals’ SOPs and FDA and ICH guidelines
• Ensures trial master file is current and maintained

Global Clinical Trial Manager – FSP

Technical Project Manager

• Execute COA systems development process from Kickoff to system go live, ongoing system change control, system closeout and database lock activities.
• Defines/redesigns COA development processes across vendor base. Identifies areas for process improvement and leads improvement activities.
• Creates and enforces the use of COA systems standards. Responsibilities may include creation / revision of COA systems standards, collaboration with vendors and internal stakeholders to define requirements, and monitoring standards utilization rate.
• Performs peer-review of the COA systems specific documentations for quality (e.g. comparing paper COA measures with Developer version etc.)
• Manages vendor performance and relationship(s). Responsibilities may include defining and implementing process with vendor representatives, monitoring and analyzing vendor and client performance metrics, performing root cause analysis and identifying corrective actions, and serving as point of escalation for vendor issues.
• Serves as project manager of all COA systems activities for protocols assigned.
• Uses interpersonal, negotiating, and project management skills to perform the following tasks: o Project plan development, execution, and change control. Coordinates resolution & risk mitigation of all IRT & COA systems related issues and end of study vendor deliverables. o Activity definition and sequencing, duration estimation, schedule development, and schedule control. o Risk management planning (i.e., risk identification, analysis, and response planning, as well as risk monitoring and control). o Communication planning, information distribution, performance reporting, and project closure.
• Obtains internal and external stakeholder feedback; this may include meeting with vendor project managers and/or meeting with subject matter experts or representatives from stakeholder functional areas.
• Provides support for successful integration of client and vendor systems.
• Provides support for problem resolution between COA vendors and client ’ s Clinical Trial Team.
• May participate in training and education for stakeholders. May develop, or assist in development of, reference and/or training material. May provide cross-functional internal and external communication as needed.
• May provide support for the development / maintenance of relevant documentation, including applicable SOPs, job aids, and guidance documentation.
• May mentor new staff.
• May lead a continuous improvement special project or any other project or perform any other COA related task deemed appropriate by management.

eCOA Technical Project Manager

Research Analyst

• Contributes to the selection of potential investigators
• Trains, supports, and advises Investigators and site staff in study related matters
• Ensures the sites are inspection ready at all times
• Initiates, monitors, and closes study sites in compliance with Client Procedural Documents
• Drives performance at the sites
• Performs monitoring visits (remote and onsite)
• Follows up on outstanding actions with study sites to ensure resolution in a timely manner
• Ensures compliance with the Client’s Code of Ethics and company policies

Clinical Research Associate I/II/Senior – FSP

Clinical Operations

• The Project Manager drives the planning, execution, and delivery of internal initiatives across Study Management functions.
• Ensure projects are scoped clearly, resourced appropriately, tracked rigorously, and communicated transparently.
• Partner closely with Associate Directors to shape and execute the Program/Project strategy, goals, and plans.
• Manage workstream meetings, agendas, discussions, and minutes.
• Provide timely, substantive updates to senior management in partnership with the Clinical Operations Director.
• Own key documents including ADI, status updates, and timeline updates.

Clinical Project Manager – FSP

• 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. (Occasionally this may involve leading and presenting at study-related meetings).
• 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.

Clinical Trial Specialist – Associate Clinical Operations Leader

Procurement

• Provide tactical sourcing solutions for depot, investigation medicinal product, courier, and ancillary supplies.
• Analyze and understand complex customer requirements.
• Provide professional advice and ongoing support to meet study requirements.
• Play a leading role in supplier management, working closely with key local/regional suppliers.
• Own and action help desk sourcing queue tickets.
• Execute sourcing activities on demand to support study needs.
• Deal with returns and refunds and assist internal customers with return forms.