Worldwide Clinical Trials

Operations

• Oversee operational work related to rater selection, certification/qualification, training content, scale acquisition, surveillance maintenance, and workbook/source document management
• Ensure assigned projects are timely and compliant with SOPs, ICH/GCP, and regulatory guidelines
• Coordinate completeness of rater experience qualification documents and communicate results to Sponsors and study teams
• Develop study-specific rater training web portals and ensure readiness to study timelines
• Coordinate Investigators’ Meetings and associated CAT materials
• Organize editing and formatting of didactic training presentations
• Oversee scale and study source workbook management, including licenses, translations, regulatory authorizations, and Sponsor approvals
• Maintain data surveillance methodology by tracking and reconciling source documentation and providing reports
• Provide CAT data for Final Study Reports
• Oversee archiving of CAT study documents
• Consult on rater training and data surveillance plans
• Develop and present at Sponsor Kick-Off Meetings regarding CAT operations
• Work with the Operations Director and study team to meet budgetary demands
• Manage assigned Operations staff
• Perform other duties as assigned

Manager, Clinical Assessment Technologies Operations

Clinical Research

• Manage research activities at sites participating in Worldwide’s clinical research projects
• Support all stages of clinical studies, including site identification, study start-up, regulatory document collection, contract and budget negotiation, site training, study maintenance, and site closeout
• Conduct study initiation visits (SIVs)
• Ensure compliance with informed consent, safety-event reporting, and applicable regulatory requirements while managing sites remotely

Senior Clinical Research Associate – CNS

Director

• Provide global innovative and creative leadership of the Data Management department across several sites and countries
• Plan and develop overall strategies for the Data Management and Database Programming department, including system and resource needs
• Assume responsibility for departmental efficiency using quality and efficiency metrics and customer feedback
• Monitor departmental budgets and oversee project PPRs, ensuring adherence to trial budgets and timelines
• Manage staff allocation, ensuring sufficient expertise and appropriate delegation
• Supervise, coach, mentor, and conduct performance appraisals and development reviews for Data Management staff
• Identify departmental training requirements and provide or source training
• Provide expert advice on general and project-specific Data Management issues
• Design solutions supporting Data Management and clinical trial management and clinical data requirements
• Liaise with technology and scientific/medical colleagues
• Serve as point of contact and escalation for Sponsor personnel
• Ensure departmental SOPs and non-project-specific procedures are written and updated
• Ensure compliance with Good Clinical Practice guidelines, departmental SOPs, and Sponsor requirements
• Support Business Development activities, including bids, proposals, and Bid Defence meetings
• Provide technical advice and support on Data Management topics to other departments
• Represent Data Management within Worldwide
• Cooperate with Sponsor auditors and regulatory authorities and ensure recommendations are addressed with senior management

Senior Director, Data Management

• Manage research activities at sites participating in Worldwide’s clinical research projects
• Identify potential sites to participate in research
• Perform study start-up activities, including collecting regulatory documents from sites
• Support negotiation of contracts and budgets
• Train sites to collect data properly and report potential safety-related events
• Manage site activities during study maintenance
• Close down research activities at sites once the study has concluded
• Conduct study initiation visits (SIVs)
• Ensure compliance with informed-consent procedures, safety-event reporting, and applicable regulatory requirements

Senior Clinical Research Associate – Oncology

• Provide leadership and direction to clinical site management team members from study start through closure
• Serve as Site Management’s primary point of contact and representative for clinical monitoring and site activities within the project
• Serve as the primary sponsor contact
• Manage monitoring deliverables to achieve the study budget
• Identify out-of-scope activities

Senior Clinical Trial Manager – Hematology/Lymphoma

Project Manager

• Coordinate and manage clinical trials from start up through close out activities
• Define and manage project resource needs and establish contingency plans for key resources
• Ensure successful design, implementation, tracking and revision of project plans for assigned projects
• Ensure project deliverables meet customer time, quality and cost expectations
• Meet financial performance targets for assigned clinical projects
• Serve as a key client contact for assigned projects
• Collaborate with scientific and therapeutic leadership across project teams
• Provide flexible, innovative, and proactive project solutions

Associate Project Manager – Oncology

• Manage research activities at sites participating in Worldwide’s clinical research projects
• Participate in all stages of clinical studies, including identifying potential sites
• Perform study start-up activities, collect regulatory documents, and support contract and budget negotiations
• Train sites to collect data properly and report potential safety-related events
• Manage site activities during study maintenance
• Close down research activities at sites after study completion
• Conduct study initiation visits (SIVs)
• Ensure compliance with informed consent, safety-event reporting, and applicable regulatory requirements

Senior Clinical Research Associate – CNS/Psychiatry

Associate

• Arrange and track system access for the project team
• Maintain and quality audit documents on project portals
• Assist with preparation and shipment of clinical trial documentation, including Investigator Site File
• Maintain version and quality control of project documentation and submit to trial master file
• Track and maintain project-related information, including site medical question and answer logs
• Generate and distribute minutes for project-related meetings, including Sponsor and Internal Management meetings
• Maintain current participating site and personnel information
• Arrange and track distribution of project-specific training to the project team
• Perform other duties as assigned

Clinical Trials Associate

• Arrange and track system access for project team members
• Maintain and quality audit current document revisions on project portals
• Assist with preparation and shipment of clinical trial documentation, including Investigator Site File
• Maintain version and quality control of project documentation and submit it to the trial master file
• Track and maintain project-related information, including site medical question and answer logs
• Generate and distribute minutes for project-related meetings, including Sponsor and Internal Management meetings
• Maintain current participating site and personnel information
• Arrange and track project-specific training distribution to the project team
• Perform other assigned duties

General

• Develop, review, and assist with negotiation of Site Agreements with institutions and investigators
• Provide oversight and expertise for site contract activities throughout clinical trials
• Develop investigator grants, Clinical Trial Agreement templates, and applicable plans
• Prepare country contract templates
• Draft and send Site Agreements and site-related contracts for negotiation
• Provide execution timelines and site negotiation status
• Coordinate translation of contract materials when applicable
• Review study budgets and costs related to contract negotiation
• Negotiate contract language and budgets through finalization and execution
• Escalate requests outside preapproved parameters, risks, and non-responsive sites
• Add equipment information or appendices to Site Agreements when required
• Create donation agreements and termination letters as applicable
• Review contracts for completeness and accuracy
• Finalize contracts and budgets with sites
• Perform quality checks before signature processes
• Provide contracts and budgets to regulatory teams for submissions when requested
• Liaise with legal, data privacy, study teams, sponsors, sites, investigators, and other stakeholders
• Facilitate contract signatures
• Distribute executed agreements to sites, eTMF, payment teams, sponsors, and internal SharePoint
• Maintain real-time tracking tools
• Review TMF structure and oversee Investigator Grants Budgets
• Act as lead and subject matter expert on site agreements and related processes
• Coordinate master budgets, contract plans, and budget plans
• Communicate contracting strategies, timelines, and tracking requirements
• Develop mitigation plans, resolve negotiation issues, and contribute to process improvement initiatives
• Perform other duties as assigned

Manager, Clinical Assessment Technologies Operations

Senior Clinical Research Associate – CNS

Senior Director, Data Management

Senior Clinical Research Associate – Oncology

Senior Clinical Trial Manager – Hematology/Lymphoma

Associate Project Manager – Oncology

Senior Clinical Research Associate – CNS/Psychiatry

Clinical Trials Associate

Clinical Trials Associate

Senior Specialist