Worldwide Clinical Trials

Compliance

• Support regulatory submissions, site activation, and maintenance for awarded projects
• Serve as the primary point of contact for sites throughout site start-up, from site identification to activation and maintenance
• Act as the country-level internal point of contact for regulatory and site activation activities
• Customize country-specific patient information sheets, informed consent forms, labels, and local regulatory documents
• Review and advise on country timelines
• Communicate submission status and action plans to the Regulatory Affairs Manager and project team
• Collect, receive, and perform initial reviews of study-specific site regulatory and essential documents
• Track regulatory documents by site and country and follow up with sites and internal team members
• Identify country- and site-level risks and generate mitigation strategies
• Advise on appropriate country regulatory strategies
• Maintain communication with sites to ensure timely completion of start-up and maintenance activities
• Provide updates on changing regulatory requirements and support interpretation of new regulations
• Maintain the regulatory intelligence database for the assigned country
• Provide local quality control of submission dossiers when required
• Support translation review of submission documents when needed
• Perform other assigned duties

Regulatory and Site Activation Specialist

People Operations

• Maintain accurate and timely employee data in the HCM system
• Support employment lifecycle activities, including provision and storage of personal documentation
• Support global employment registration and deregistration activities
• Receive, analyze, and process voluntary and involuntary separation requests and create separation packages
• Provide benefits and leave administration according to documented local requirements
• Serve as a resource for policy and process-related workforce management transactional questions
• Maintain documentation for core People Services activities in compliance with policies and legal requirements
• Evaluate existing processes and recommend improvements to departmental efficiency and service delivery
• Manage employee data for reporting and compliance purposes
• Support remuneration processes with internal and external partners
• Provide on-site support as required
• Deliver operational and transactional support throughout the employee lifecycle
• Provide customer service to the global People team, leaders, and employees while following global compliance regulations

People Services Specialist I

Manager

• Lead strategy, governance, and continuous improvement for learning operations, compliance training support, performance management, and talent enablement
• Oversee enterprise training operations, LMS governance, audit readiness support, and related process execution
• Partner with leaders, executive sponsors, and stakeholders to identify capability needs, training priorities, process risks, and scalable solutions
• Establish roles, responsibilities, standards, and operating processes for learning, training, audit support, and talent initiatives
• Serve as a strategic advisor on training operations, compliance and technical training enablement, performance processes, talent practices, and change adoption
• Oversee compliance training administration, required training assignment, tracking, reporting, documentation, and LMS administration
• Ensure training processes are accurate, timely, auditable, and aligned with procedural, regulatory, and inspection-readiness expectations
• Oversee the design, deployment, and sustainment of functional and technical training programs
• Translate role-, system-, process-, and compliance-based needs into practical training solutions
• Guide training plans, learning paths, system training, job aids, communications, learner support, and stakeholder readiness activities
• Use data and reporting to monitor completion, identify risks, assess process performance, support audit readiness, and inform decisions
• Lead process improvements involving training administration, curriculum governance, documentation quality, stakeholder engagement, and operational efficiency
• Leverage technology, automation, analytics, and emerging practices to modernize learning delivery and compliance training support
• Support enterprise performance management processes, tools, communications, goal setting, check-ins, and year-end activities
• Support talent reviews, succession planning, calibration, leadership pipeline visibility, and related enablement activities
• Build trusted relationships with executive sponsors, HR, Quality, Compliance, IT, business leaders, and functional stakeholders
• Facilitate working sessions and planning forums, resolve gaps, align decisions, and drive accountability
• Support change management by equipping leaders, managers, and employees with information, tools, and resources
• Lead, coach, and develop team members responsible for learning operations, training administration, audit coverage, compliance training, and talent processes
• Set priorities, expectations, decision rights, and accountabilities; foster collaboration and continuous improvement
• Perform other duties as assigned

Senior Manager, Organizational Learning & Talent Enablement

Clinical Research

• Manage one or more allocated Phase I through IV clinical trials, which may be local, regional, or global in scope
• Coordinate and manage clinical trials from start-up through closeout
• Direct the technical, financial, and operational aspects of projects
• Work with functional area leads to identify and evaluate project requirements
• Interpret data on complex issues
• Conduct contingency planning and implement rescue strategies when needed
• Ensure solutions are implemented
• Ensure project deliverables meet customer time, quality, cost, and contract expectations
• Lead core project team members and facilitate leadership of extended or complete project teams
• Lead internal and external cross-unit coordination, including subcontractors
• Define and manage project resource needs and establish contingency plans for key resources
• Ensure successful design, implementation, tracking, and revision of project plans
• Promote effective teamwork and resolve conflicts
• Ensure appropriate communication on project-related matters with CSM Management
• Work under the direct supervision and guidance of the Site Director; does not supervise other staff

Clinical Study Manager

• 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 while managing sites remotely

Senior Clinical Research Associate – CNS/Psychiatry

• Manage research activities at sites participating in Worldwide’s clinical research projects
• Identify potential sites to participate in research efforts
• Perform study start-up activities, including collecting regulatory documents and supporting 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 once the study has concluded
• Conduct study initiation visits (SIVs)
• Ensure compliance with informed consent, safety-event reporting, and applicable regulatory requirements

Senior Clinical Research Associate – Psychiatry

Data Coordinator

• Review study protocols for assigned studies
• Ensure source-document data is accurately reflected on electronic or paper Case Report Forms
• Track source documents filed into subject folders
• Assist with reconciliation of study records for archive
• Identify and report problems or potential problems to the supervisor
• Request, schedule, and attend required training
• Work under the general supervision and guidance of the Senior Manager, Study Conduct

PRN Data Coordinator

Project Manager

• Manage and direct the Project Management team within a therapeutic group
• Ensure successful conduct of assigned projects
• Recruit, train, develop and conduct performance reviews for personnel
• Support strategy and acquisition of new business with business and senior management
• Develop and maintain effective client relationships
• Manage alliance partnerships and serve as WCT’s primary contact with sponsors where appointed
• Lead sub-therapeutic groups when appointed
• Oversee overall project financial performance across all departments
• Oversee development, implementation and adherence to project plans and performance indicators
• Conduct budget reviews and provide financial analysis support
• Review and approve strategy, content and costing of new business proposals
• Identify resource needs for new projects and meet resource management and utilization targets
• Conduct project and sponsor relationship reviews
• Facilitate resolution of sponsor relationship issues
• Provide capabilities presentations and attend bid presentations
• Ensure project deliverables meet sponsor and WCT expectations
• Participate in company initiatives and perform other duties as assigned

Executive Director, Project Management

• Lead enterprise digital adoption and systems enablement strategy across Medidata, Certinia, LMS, Workday, Percipio, Microsoft 365, Copilot, Teams Rooms, Zoom, and other assigned systems
• Manage two Organizational Learning Advisors, Enterprise Systems, including coaching, feedback, goal setting, performance management, development planning, capacity planning, workload prioritization, and quality oversight
• Establish standards, templates, and operating practices for systems learning
• Oversee learning and enablement plans for implementations, releases, enhancements, new modules, new hire training, refresher training, remediation, and adoption campaigns
• Guide development of role-based learning journeys, job aids, quick reference guides, instructor-led and virtual sessions, videos, eLearning, office hours, workshops, embedded guidance, and performance support resources
• Serve as senior learning advisor and escalation point for training, communication, process clarification, system support, access guidance, remediation, or combined solutions
• Partner with EPMO, IT, Clinical Systems, Finance, Project Operations, HRIS, QA/compliance, system owners, process owners, SMEs, Corporate Communications, instructional designers, LMS administrators, and business leaders
• Ensure enablement coverage for Medidata, Certinia, corporate platforms, collaboration tools, and other business systems
• Publish a recurring Digital Adoption & Enablement scorecard with adoption insights, utilization trends, learning completion, proficiency indicators, support trends, remediation themes, business value narratives, and recommended actions
• Coordinate learning plans with business-owned communications
• Represent GOLD in cross-functional forums
• Maintain governance artifacts, templates, communication assets, release materials, adoption toolkits, measurement approaches, embedded guidance standards, and AI-enabled content methods
• Use learner, SME, helpdesk, system owner, and stakeholder feedback to improve training, performance support, adoption, and remediation cycles
• Perform other duties as assigned

Senior Manager, Digital Adoption & Enablement

• Serve as the primary point of communication and accountability for study start-up and maintenance activities on assigned projects
• Oversee project activities of functional groups involved in site activation to ensure critical path activities are completed on-time and within budget
• Ensure accurate compilation, management, tracking, and analysis of site activation activities in a timely manner
• Support feasibility and/or site identification activities as needed
• Work closely with assigned team members to expedite the Site Qualification and Selection process
• Communicate Site Activation & Regulatory project status to the Sponsor, GPL/CPM, and project team
• Partner with Commercial and Therapeutic Area Leadership to translate business priorities into integrated marketing initiatives

Site Activation Manager

• 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
• Act as the primary sponsor contact
• Manage monitoring deliverables to achieve the study budget
• Identify out-of-scope activities

Senior Clinical Trial Manager – Oncology

• Coordinate and manage clinical trials from start-up through closeout activities
• Direct the technical, financial, and operational aspects of projects
• Secure successful completion of clinical trials
• Work with major functional area leads to identify and evaluate fundamental project issues
• Interpret data on complex issues and make business decisions
• Ensure solutions are implemented
• Ensure project deliverables meet customer time, quality, and cost expectations
• Collaborate with Project Management Directors and other functional area leads
• Ensure project deliverables meet customer and contract expectations

Senior Project Manager – CNS

• Develop oncology clinical data review plans for assigned studies
• Conduct ongoing oncology clinical data review and analysis, including efficacy and safety-related data, using listings, visual analytics, tables, figures, graphs, and EDC
• Present key oncology data trends and findings to the Medical Monitor, Study Team, and Client
• Collaborate with cross-functional study team members to ensure protocol-defined variables are collected and reported accurately
• Track and analyze potential safety events with Pharmacovigilance and Medical Monitoring
• Contribute to discussions on potential study or strategy modifications based on clinical data review
• Create data summary slides for Safety Review Committee Meetings and Data Review Meetings
• Query EDC data during clinical review, follow up promptly, and identify potential protocol deviations
• Partner with vendors and study team members to ensure accurate endpoint reporting
• Serve as a point of contact for site staff and monitors for protocol and clinical inquiries
• Collaborate with Data Management on CRF design, CRF instructions, and data quality plans
• Review data-driven sections of regulatory and clinical reporting documents, including CSRs, INDs, NDAs/BLAs, annual reports, and IBs
• Provide scientific writing support for patient narratives, abstracts, posters, and presentations
• Mentor and train junior staff
• Utilize visual analytics tools to interpret and communicate data insights

Clinical Scientist

• Conduct site qualification, initiation, interim monitoring, site management, and study close-out visits
• Provide mentoring and guidance to less experienced CRAs and site staff when needed
• Document site visit findings via written reports
• Assess, monitor, and train study site staff on protocol adherence
• Review study subject safety information and informed consent
• Conduct source document verification for compliance, patient safety, and data veracity
• Review CRFs using paper or electronic data capture systems and assist sites with data query resolution
• Provide applicable updates for site-related documentation for filing in the Trial Master File (TMF)
• Ensure site compliance with investigational product receipt, accountability, and return or destruction
• Conduct accompanied site visits for assessment or training of other CRAs as requested and appropriate

Senior Clinical Research Associate

Associate

• Arrange and track system access for project team members, including Project Managers, Lead CRAs, and CRAs
• Maintain and quality audit project portal documents to ensure the most recent revisions are available
• Assist with preparation and shipment of clinical trial documentation, including Investigator Site Files
• Maintain version and quality control of project documentation and submit documents 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
• Provide administrative and project tracking support to clinical project teams
• Ensure assigned project tasks are performed timely and accurately