WEP Clinical

Human Resources

• Support onboarding activities, including pre-boarding tasks, new hire communications, orientation scheduling, and follow-up support
• Prepare and maintain onboarding materials, orientation resources, new hire checklists, and process documentation
• Provide administrative support to new hires by tracking required tasks, answering routine process questions, and escalating issues
• Maintain accurate employee records in HR systems according to internal procedures and confidentiality requirements
• Review HR data for accuracy, completeness, and consistency and support corrections
• Prepare HR reports, dashboards, trackers, and data summaries
• Support the mentor program through mentor/mentee coordination, participation tracking, communications, and feedback gathering
• Contribute to the HR newsletter by gathering updates, drafting content, and organizing submissions
• Assist with HR Operations tasks, audits, documentation updates, and process improvement initiatives
• Provide administrative and project support across HR Operations, employee communications, team coordination, and other HR initiatives

HR Intern

Manager

• Oversee and support sales operations for WEP service lines from initial deal stage through handoff to Project Management
• Act as the primary internal point of contact for RFI and RFP responses
• Develop and execute pricing strategies for WEP service lines
• Draft client-focused proposals, quotes, and RFI documents with Business Development
• Use internal pricing tools and market analysis to build program budgets and pricing models
• Conduct P&L analyses to evaluate project budgets, profitability, and pricing adjustments
• Coordinate with operational teams to gather assumptions and inputs for proposal budgets and timelines
• Ensure accurate ERP data entry for contract billing, forecasting, and financial reporting
• Review and validate subject matter expert inputs for operational feasibility and delivery expectations
• Facilitate alignment on pricing strategies, payment terms, and contract structures
• Identify, communicate, and mitigate potential budget risks
• Lead cross-functional teams to complete pricing and proposal submissions accurately and on time
• Negotiate directly with clients and articulate value propositions and contractual terms
• Serve as a contact for customer and vendor pricing and contract inquiries
• Review contract terms, monitor amendments, and ensure compliance with agreed conditions
• Support marketing initiatives with value-proposition content
• Prepare win/loss analyses and manage the content library and master RFP/vendor question database
• Potentially oversee and mentor team members as the business grows
• Contribute to team development, workload management, and process improvement initiatives
• Support commercial forecasting, budgeting, and long-term strategic planning

Pricing and Proposals Manager

Project Manager

• Lead and/or oversee regional and global PA-NPP or related projects, ensuring project timelines are met as per contract
• Develop, maintain, and ensure compliance of project plans, timelines, and budgets with the Scope of Work
• Lead, train, and provide operational oversight to project teams
• Oversee delegation of support staff activities and potentially line-manage direct reports
• Build and maintain positive client relationships
• Communicate with clients to maintain operational processes and deliver projects within scope
• Identify, evaluate, monitor, and mitigate project quality risks
• Communicate risks to internal teams, upper-level management, and clients as appropriate
• Develop and document study-specific training requirements
• Prepare and finalize Out of Scopes and develop change orders with Business Development
• Ensure project teams manage programs according to WEP Clinical SOPs and Policies
• Participate in proposal meetings for potential clients
• Review Electronic Trial Master File documentation, including treatment guidelines, protocols, case report forms, informed consent documents, investigator agreements, brochures, logic checks, and data handling guidelines
• Assist management with developing, documenting, and updating internal procedures, SOPs, working practices, and quality assurance forms
• Provide operational oversight during programs and projects
• Review site visit preparation documents, site visit reports, and site payments
• Audit eTMF and CTMS compilation and completion
• Maintain current knowledge of FDA, GDPR, global regulations, and GCP/ICH Guidelines for PA-NPP and clinical research

Senior Project Manager, French Speaking

QA Engineer

• Oversee, implement, and continuously improve GCP quality systems supporting global clinical operations and decentralized clinical trials
• Provide quality leadership and strategic quality advice to operational teams and departments
• Manage day-to-day Clinical Quality team activities, including workload planning, performance management, coaching, training, and professional development
• Oversee QMS records, including deviations, non-conformances, complaints, protocol deviations, CAPAs, change controls, risk assessments, and quality events
• Review and approve investigations and monitor CAPA effectiveness
• Track inspection trends, quality metrics, KPIs, and emerging compliance risks
• Provide quality oversight for nursing services, home healthcare, investigational product handling, source documentation, and patient-facing clinical processes
• Lead quality oversight for new services, vendors, systems, operational changes, computerized system validation, equipment qualification, and process validation
• Review clinical trial documentation including protocols, ICFs, eCRFs, Pharmacy Manuals, Monitoring Plans, and essential documents
• Support vendor qualification and oversight, audits, requalification, Quality Technical Agreements, and vendor performance monitoring
• Lead Sponsor audits, regulatory inspections, licensing authority inspections, and client qualification audits
• Drive continuous improvement, QMS updates, quality governance, risk-based decision-making, stakeholder collaboration, patient safety, and operational excellence

Clinical Quality Assurance Manager

• Ensure GMP and GDP compliance across all regulated activities, maintaining best practices at all times.
• Prioritize and oversee compliance activities related to Wholesaler and Manufacturing Licenses/Authorisations in line with regulatory expectations.
• Manage key quality processes, driving operational compliance and identifying risks to patient safety, product quality, or regulatory adherence with effective mitigation strategies.
• Monitor, trend, and analyze quality incidents and metrics, proposing improvements to prevent recurrence and support management review.
• Lead and coordinate investigations for deviations, non-conformances, and complaints, ensuring robust root cause analysis and effective CAPA implementation.
• Initiate and support risk assessments, validation protocols, periodic reviews, and other quality system activities, including post-effectiveness checks for CAPAs and Change Controls.
• Drive timely completion and closure of critical quality records, ensuring appropriate supporting evidence is in place.
• Lead and support change controls, assessing impacts and risks and implementing necessary mitigating actions.
• Coordinate product recalls and mock recalls as required.
• Create, maintain, review, and archive GxP documentation, ensuring controlled document updates and effective document lifecycle management.
• Develop and execute validation and qualification strategies for shippers, equipment, facilities, IT systems, and warehouse operations, ensuring GMDP compliance.
• Support product disposition from quarantine, perform batch reviews, line clearances, quality inspections, label reviews, and secondary packaging oversight in accordance with SOPs.
• Support batch certification activities, including completion of Product Specification Files and escalation of quality issues to the Qualified Person as needed.
• Provide quality oversight and support for commercial, clinical trial, and supply chain projects, including client calls, technical agreements, audits, and regulatory inspections.
• Contribute to internal and external audits, supplier and vendor qualification, training, and continuous process improvements while promoting collaboration across the global Quality team and wider business.

Senior Quality Assurance Associate

• Responsible for the leadership and operational execution of the site quality assurance function regarding the distribution and manufacturing (secondary packaging & labelling) activities.
• Oversee and drive day-to-day site operations, driving compliance to regulatory Good Manufacturing and Distribution Practice standards and operational improvements.
• Act as a primary expert and interface between supply chain and logistics, project management and other departments to drive delivery of client solutions with respects to Post Approval Named Patient/Expanded Access Program and Clinical Trial supply service lines for the site.

Senior Clinical Quality Assurance Associate

Research Analyst

• Schedule and perform on-site or remote monitoring visit activities, inclusive of the following study visit types: Site Initiation Visit (SIV), Interim Monitoring Visit (IMV) / Routine Monitoring Visit (RMV), and Close Out Visit (COV).
• Contribute to the development of protocols, study tools, materials, and documentation for clinical sites.
• Provide feedback to assist sites with resolution of detected deficiencies and corrective action needed.
• Review site-level investigational drug accountability and safety event documentation.
• Review and verify patient files and records, informed consent, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identify deficiencies; provide training and/or initiate corrective action as required.
• Identify, document, track, and report site protocol deviations and violations as defined within the EAP Monitoring Plan.
• Manage query resolution.
• Provide mentoring, training, and co-monitoring of junior team members.
• Assist in the development of applicable WEP Clinical Standard Operating Procedures.
• Develop applicable document templates, including (but not limited to), Monitoring Plans, Monitoring Visit Reports, Confirmation Letters, Follow-Up Letters, and Query Logs.
• Complete, review, and/or submit monitoring reports and query logs.
• Address protocol or monitoring-related questions received from clinical sites for assigned programs.

Clinical Research Associate

Associate

• Collaborate with Clinical Operations to develop site initiation timelines and ensure adherence to project milestones
• Prepare and manage site startup documentation, including contracts, informed consent forms, and regulatory submissions
• Coordinate with contracts and budget teams to ensure timely execution of site agreements
• Assist with the preparation and submission of essential regulatory documents for site activation
• Ensure all documents are approved by ethics committees and IRBs before site activation
• Track progress of regulatory submissions, site contracts, and essential document collection
• Verify site readiness with adequate resources and completed training prior to patient enrolment
• Participate in study kick-off and initiation meetings to align expectations and timelines
• Troubleshoot activation issues and escalate problems to the Project Manager or CRA when needed
• Assist with the setup of study supplies and equipment at the site, including investigational products and lab kits