Worldwide Clinical Trials

Statistician

• Manage the statistics support to one or more projects/sponsor programs of work
• Provide expert review of study designs, analysis plans, and reports
• Assist sponsors in the design of clinical trials
• Provide project support to the statistics reporting process
• Prepare final reports, including the production of tables, listings, and figures
• Develop, evaluate, and run Statistical Analysis System (SAS) programs

Senior Statistician

Data Coordinator

• Reviews study protocol for studies assigned
• Ensure data from source documents for the trial are accurately reflected on the Case Report Form
• Keep track of source documents being filed into subject folders
• Assistance with reconciliation of study records for archive
• Identifies problems or potential problems and reports them to his/her supervisor
• Responsible for requesting, scheduling and attending any training required for this position

Manager

• Overall management of activities involved in the development/preparation and revision of contracts/change orders
• Manage a variety of clinical, services, and related local and global contracts
• Responsible for preparing the contract by drafting and incorporating budget, scope of work, and legal, financial, and operational terms
• Ensure adherence to master agreements and provide advice on contract management

Contract Manager

• Serve as the primary point of accountability for site activation and start-up activities on assigned studies
• Oversee cross-functional site activation activities to ensure milestones are achieved on time and within budget
• Manage the accurate tracking, analysis, and reporting of site activation progress and metrics
• Partner with project teams to support feasibility, site qualification, selection, and regulatory activities as needed
• Communicate site activation status, risks, and mitigation plans to Sponsors, project leadership, and internal teams
• Develop and maintain site activation project plans and support risk assessment and issue resolution
• Ensure site activation activities are appropriately budgeted, with out-of-scope work tracked and managed through change control
• Drive continuous improvement through SOP development, best practices, metrics, and departmental initiatives
• Contribute to business development activities, including proposal development and bid defense support
• Liaise with internal stakeholders and external vendors, escalating issues as needed to ensure on-time delivery
• Ensure compliance with SOPs, ICH GCP, and applicable regulatory requirements

Site Activation Manager

General

• Provide administrative and project tracking support to the clinical project team
• Ensure tasks for assigned projects are performed timely and accurately
• Arrange and track system access for project team
• Maintain and quality audit project documents
• Assist project team with clinical trial documentation preparation and shipment
• Maintain version and quality control of project documentation
• Assist with tracking project related information

Clinical Trials Associate

Project Manager

• Be accountable for multiple projects simultaneously
• Work effectively across multiple divisions to direct the delivery of projects/programs within cost, time and quality requirements
• Serve as a liaison with Business Development and Bids/Contracts for client presentations and proposal development
• Work with leadership in all functional areas on continuous development/improvement of business processes

Associate Director – Project Management, Renal Diseases

Strategy

• Lead business analytics for the commercial organization
• Track and manage margin analysis of awarded work
• Assess and deploy new tools and technologies
• Oversee the evolution, management, and implementation of Salesforce
• Conduct continual review and assessment of market trends
• Liaise with other market analysts
• Provide market analysis presentations
• Support the commercial team with bid defense preparation
• Collaborate with all functional areas on key performance indicators

Principal Market Analysis – Corporate Strategy

Business Development Rep

• Achieve individual revenue and sales objectives through proactive sales and marketing of Worldwide’s services to assigned clients.
• Identify new contact leads for potential clinical, bioanalytical, and ADME business.
• Responsible for writing basic clinical and bioanalytical proposals, communicating with clients, internal Clinical Study Managers, and Bioanalytical Study Managers and other duties required to generate new business.
• Provide client benefit presentations of Worldwide’s services to all key accounts and in pursuit of all new business opportunities.
• Provide daily updates to the Worldwide Sales Force Automation Client Contact and Mailing Database (CRM).
• Actively participate and provide account input for proposal development, pricing and database requirements.
• Actively engage senior management in all major business presentations, and discussions on Requests For Information (RFI), Master Service Agreements (MSA) and Preferred Provider Agreements (PPA).
• Able and willing to travel throughout assigned geographical territory and nationally.

Senior Director, Business Development

• Responsible for overall coordination of clinical trials
• Directs technical, financial and operational aspects of projects
• Ensures all deliverables meet time/quality/cost expectations
• Works with functional area leads and interprets data on complex issues

Senior Project Manager, Oncology

Operations

• organize the goal planning and quarterly business reviews for Operational results
• drive the accountability of action items through the team
• onboard team members and manage the first 30/60/90-day dialogue
• attend meetings on behalf of TAL and act on their behalf
• prepare communications on behalf of TAL to share with other leaders

Operations Support Manager

Medical Director

• Identify operational needs for upcoming projects, track and review current assignments for CAT Operations staff
• Resource CAT study projects as Resource Manager
• Engage as Subject Matter Expert (SME) for CAT Operations activities
• Provide operational oversight for designated CAT study projects
• Engage in and coordinate resourcing activities for all CAT awarded projects
• Identify training and skills gaps among staff; coordinate and assist with learning opportunities to enhance operations staff knowledge and skills of industry related regulations, processes, materials, and guidelines
• Actively identify and engage in process improvement activities
• Participate in QMD reviews and new QMD development
• Author, collaborate, and review QMD documents and guidance documents
• Coordinate and manage CAT Operations team meetings
• Active engagement and oversight of study risk assessments, as they relate to operational activities
• Work with department leaders to ensure alignment among CAT operational and clinical services
• Lead and/or contribute to departmental initiatives that aim to implement policies, methods, techniques to contribute to existing service areas and department growth
• Accountable for oversight of CAT study deliverables from Launch process to study close out
• Assist and collaborate with Operations staff, Project Management, Contracts on vendor and study budget development, scope of work revisions, tracking and compliance
• Assist in vendor management related concerns, including involvement with escalations, Vendor Management and Quality Assurance meetings
• Review and assess ongoing budget utilization and revenue recognition with Operations Managers to ensure projects are meeting financial targets
• Manage internal CAT operations meetings and other trial-specific meetings, as appropriate
• Significant contributor to multiple strategic departmental, sponsor-related and cross-functional initiatives
• Participate in business development activities including; but not limited to proposals input, capabilities, and bid defense meetings
• Apply thorough knowledge of industry regulations and guidelines to ensure operational compliance during clinical trial conduct

Associate Director, Operations – Clinical Assessment Technologies

• Serves as a direct Line Manager for IG Forecasting team members
• Leads the overall development, delivery and maintenance of forecasting tools, process, and deliverables
• Tracks and monitors FTE resourcing and team output reports
• Analyze operational project data as it pertains to relevant financial metrics
• Prepare and present financial reports and analyses
• Maintain portfolio-level financial forecasts
• Responsible for establishing close relationships with IG Planning, Clinical Payments, Project Management and Site Activation to ensure accurate, complete and timely deliveries of IG Forecasts
• Leads the development and maintenance of processes, policies, SOPs and associated documents concerning IG Forecasts
• Oversee team of IG Forecasting Analysts working with Project Management to determine monthly invoicing and accruals
• Manages vendor relationships and licensing strategy, alongside IG Planning, pertaining to IG Forecasting tools
• Trains and mentors IG Forecasting team members on lines of communication, applicable tools, Working Instructions, preferred processes and SOPs
• Provides expert guidance in the development/rollout of process improvement initiatives
• Responsible for maintaining accuracy and completeness of all IG Forecasting task tracking
• Assists other departments in leading or participating in departmental initiatives and additional training where necessary (i.e. IG Planning, Clinical Payments, Site Contracts)
• Collaborates with IG Planning and Clinical Payments for improvement of departmental tools and processes related to IG Forecasting
• Perform other duties as assigned

Manager, Investigator Grants – Forecasting

Research Analyst

• Responsible for managing the research activities at sites participating in Worldwide’s clinical research projects
• Conduct study initiation visits (SIVs)
• Ensure compliance with obtaining informed consent, reporting potential safety-related events, and adhering to all applicable regulatory requirements
• Perform various study start-up activities such as working with sites to collect appropriate regulatory documents and supporting the negotiation of contracts and budgets
• Train sites to collect data properly and report any potential safety-related events
• Manage the site's activities during study maintenance and closing down research activities at the sites once the study has concluded

Senior Clinical Research Associate – CNS/Rare Disease

• Responsible for managing the research activities at sites participating in Worldwide’s clinical research projects
• Involved in all stages of the clinical study, including identifying potential sites, performing various study start-up activities, training sites, managing site activities, and closing down research activities
• Conduct study initiation visits (SIVs)
• Ensure compliance with obtaining informed consent and adhering to regulatory requirements

Senior Clinical Research Associate – CNS/Psychiatry

• Responsible for managing the research activities at sites participating in Worldwide’s clinical research projects
• Conduct study initiation visits (SIVs)
• Ensure compliance with obtaining informed consent and reporting potential safety-related events
• Collaborate with top-tier colleagues from various backgrounds and specialties