
WCG
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18 Jobs
• Assists and supports the Compliance team in establishing and maintaining quality assurance standards and measures across WCG services organization and ensuring compliance with regulatory requirements and best practices. • Performs quality process reviews to provide information to management regarding the effectiveness of WCG IRB systems. • Initiates and facilitates process improvement projects; consults with all staff on matters involving process changes. • Supports the continued development, maintenance, and enforcement of the IRB Quality Management System. • Assists senior compliance team members to establish and enforce IRB quality standards. • Coaches and trains WCG staff on IRB quality department standards and best practices. • Ensures the implementation, development, and release of controlled documents in line with regulatory agency regulations and guidance, including but not limited to, GxP, GDPR, and HIPAA. • Supports the investigation of subject/third party inquiries, maintains confidentiality and handles all matters discreetly. • Assists in the preparation of certification documentation in cooperation with appropriate business stakeholders.
• Engages in the continued development, maintenance, and enforcement of the WCG Quality Management System and quality department standards. • Supports efforts regarding the maintenance of WCG quality goals, objectives, and process improvements. • Educates WCG staff on WCG quality department standards and best practices. • Engages with WCG staff to author and revise internal technology standards (i.e. IT and/or Software Development Policies, SOPs, et al). • Supports the development, validation, implementation, and change management of systems to ensure same is performed in line with regulatory agency regulations and guidance, including but not limited to, GxP, 21 CFR Part 11/Annex 11, GDPR, and HIPAA. • Supports the investigation of Quality Events/Corrective Actions Preventative Actions (CAPA), deviations, and notes to file (NTF). Executes assigned compliance tasks in adherence of defined timelines. • Conducts internal audits to ensure internal standards and staff performance are compliant with applicable WCG process, regulatory agency regulation, and guidance. • Conducts external vendor qualification audits to ensure that vendor standards and performance are compliant with applicable WCG process, regulatory agency regulation, and guidance. • Supports external audits including audit preparation activities, review of audit report, and executing finding resolution. • Maintains current knowledge with respect to quality legislation and regulatory compliance best practice. • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
• Lead team of managers with oversight over CTMS service delivery, including calendar builds, financial entries, and study activation tracking. • Support professional and technical development of the assigned managers • Track, evaluate, and report aggregated productivity, quality, and efficiency data to ensure teams are meeting overall goals and to support departmental planning, resource allocation, and operational decision making. • Provide oversight of the training process to ensure new employee development aligns with operational needs. • Provide oversight over the quality management process to ensure final deliverables are meeting internal standards. • Monitor staffing resources, develop hiring plans, and oversee operational decisions related to talent including selection of new team members. • Serve as a key operational contact during new client onboarding as a subject matter expert, ensuring new site clients are set up on the appropriate CTMS platform in a way that aligns with internal standards and client expectations. • Establish and continuously evaluate team processes, templates, tools, and strategies to maximize efficiency, quality, scalability and overall departmental performance. • Serve as point of contact between CTMS services and Business Development to support expansion of existing relationships through new sales opportunities. • Collaborate with client management team to ensure appropriate strategies are taken when client issues or new opportunities arise. • Identify and implement new CTMS operational strategies, processes and solutions designed to meet current and emerging client needs and high client satisfaction. • Develop a deep knowledge of site client requirements and expectations, define priorities, and effectively manage deliverable planning, execution, and problem resolution with mitigation recommendations. • Establish escalation pathways and decision-making standards for complex CTMS service issues, ensuring managers have the tools, guidance, and authority needed to resolve operational challenges consistently and effectively. • Allocate staffing and operational resources across CTMS service teams to align capacity with client demand, departmental priorities, and business objectives. • Coach the CTMS Services team on study start-up principles needed for cross-divisional deliverable coordination, ensuring consistent and disciplined execution. • Provides leadership through subordinate managers and maintains accountability for the performance, engagement, development, and productivity of multiple related CTMS services teams, while engaging with Human Resources for support and guidance on personnel matters. • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here. • Attendance and punctuality are essential functions of the position.
• Design, build, and deploy internal AI agents leveraging a range of agentic platforms (e.g., Copilot, custom LLM frameworks, low-code platforms, and external AI ecosystems). • Own and maintain the enterprise Agent Registry, including metadata, ownership, usage metrics, lifecycle status, and audit traceability for all agents. • Define and implement enterprise risk tiering for AI agents based on data sensitivity, autonomy level, regulatory impact, and business criticality. • Establish and enforce governance frameworks for agent development, deployment, monitoring, and retirement. • Develop and standardize approved agentic workflow patterns (e.g., human-in-the-loop, approval gating, escalation pathways, audit logging, fail-safe handling). • Prevent uncontrolled proliferation of AI agents through standardization, registry enforcement, and rationalization of redundant or overlapping solutions. • Drive enterprise adoption of AI agents for workflow automation across business units. • Identify, prioritize, and implement high-impact automation use cases across operational and business processes. • Establish standards and reusable patterns for prompt engineering, orchestration, and integration across platforms. • Monitor agent performance, risk posture, and adoption; continuously optimize for quality, reliability, and business value. • Partner with engineering teams to integrate agents with enterprise systems, APIs, and governed data sources. • Collaborate with compliance, legal, and risk teams to ensure adherence to regulatory, privacy, and security requirements. • Evaluate and onboard new agentic platforms, tools, and capabilities aligned to enterprise AI strategy. • Enable business users through structured training, documentation, and hands-on support to accelerate safe AI adoption. • Evangelize AI-first ways of working and promote disciplined agent lifecycle and governance practices across the organization. • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
• Execute and operationalize the enterprise AI strategy, ensuring alignment to business priorities and measurable outcomes • Drive design, adoption and growth of AI platforms (ML, GenAI, MLOps, LLMOps) across clinical, regulatory, and operational domains • Lead prioritization of AI initiatives, balancing short-term delivery and long-term platform evolution • Partner with executive stakeholders to translate business needs into scalable AI solutions • Establish and scale enterprise-wide architectures for AI model development, deployment, monitoring, and lifecycle management. • Drive implementation and continuous improvement of AI platform infrastructure and pipelines • Ensure AI platforms integrate seamlessly with enterprise data and technology ecosystems • Establish and enforce Responsible AI frameworks including model validation, bias mitigation, explainability, and auditability • Establish AI governance aligned with regulatory frameworks (GxP, ALCOA+, data integrity) • Build, lead, and scale high-performing, globally distributed AI engineering teams • Drive workforce planning, resource allocation, and capability building in AI engineering • Collaborate cross-functionally with product, data, compliance, and IT teams. • Manage strategic vendor relationships and AI-related third-party platforms. • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
• Accountable for account outcomes (penetration, growth, cross- selling solutions, client satisfaction and renewal strategy) • Accountable for the commercial targets for the strategic and growth accounts assigned to their global account team • Developing a solid and trusting relationship with assigned key clients, including executive-level engagement as well as peer-to-peer relationships. • Developing a complete understanding of key account needs to inform relevant solutions • Developing and enforcing account plans and sales strategies for strategic and growth accounts • Leading a cross-functional team, including business development, inside sales, marketing, product, strategic partnering, client success, and others • Coordinating multi-service line pitches and proposals • Ensuring consistent messaging and approach across reps in the team pod, including collaboration with marketing on the development of account based marketing plans and materials • Understanding client data and analytics to identify opportunities for growth for the key account players • Resolving issues or challenges that could impact our client relationships or their growth with WCG • Anticipating key account changes and improvements • Mentoring and coaching business development directors in building account plans, sales strategies, and relationships for their assigned growth accounts. • Managing communications between key clients and internal teams • Strategic planning to improve client results • Negotiating contracts and commercial terms with the client and establishing a timeline of performance • Establishing and overseeing internal budgets with the company and external budgets with the client • Collaborating with internal stakeholders across all of WCG to drive successful client outcomes, e.g., working with Product to deliver on the highest priority tech needs for our top accounts • Planning and presenting reports on account progress, goals, and initiatives to share with team members, stakeholders, and possible use in future case studies or sales training • Meeting all client needs and deliverables according to proposed timelines • Analyzing client data to provide customer relationship management • Overall responsibility for the collaboration of pod team (indirectly managing), including influencing, persuading, organization and strategic guidance • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
• Develop, validate, and document SAS programs for clinical trial datasets (SDTM, ADaM) and outputs (tables, listings, figures) for regulatory submission, ensuring accuracy and compliance. • Lead programming activities and manage resources, timelines, and priorities for assigned studies and projects. • Conduct comprehensive quality control checks and peer code reviews on all programming deliverables. • Collaborate with statisticians, data managers, and clinical teams to ensure project requirements are met and deliverables are aligned. • Conduct thorough quality control checks on programs and datasets to ensure precision and dependability. • Oversee and manage programming activities for studies or projects, handling resource allocation, timelines, and budgets. • Guide junior programmers, offering mentorship on industry standards and best practices. • Provide expertise in interpreting and implementing Statistical Analysis Plan (SAP) programming specifications and project documentation. • Troubleshoot programming and data issues, resolve discrepancies, and ensure timely, reliable data reporting. • Coordinate multiple projects concurrently, setting strategic goals and adapting to evolving priorities. • Foster innovation within the department and contribute to process enhancement initiatives. • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
• Creates basic Array activity builds (uploading slides, managing polling surveys, other administrative functionality) and makes content adjustments to meeting activity before and during meetings as required • Assists in network setup to run Array application on iPads (in-person meetings) • Ensures equipment is received, cleaned, charged and in working order for each on-site meeting • Instructs client on proper use of the Array technology and other technical aspects of live meetings • Validates and issues post meeting reports and data as required • Maintains up-to-date knowledge of company technology and service offerings • Delivers outstanding customer service, ensuring client satisfaction across all interaction points • Works seamlessly within teams and independently, adapting to various work settings and client needs • Provides business support to Project Managers as requested • Travels to meeting locations as needed, providing on-site support and ensuring smooth technology implementation • Fosters and maintains strong client relationships, acting as a trusted advisor and liaison • Manages time effectively, balancing multiple tasks and adapting to shifting priorities • Identifies opportunities for operational improvement • Other duties as assigned by supervisor. These may, on occasion, be assigned by an up-line supervisor and/or be unrelated to the position described here.
• Conduct deep-dive analyses to uncover drivers of financial performance, customer behavior, and sales trends. • Communicate analysis of findings, trends, and recommendations to Finance and Commercial stakeholders to influence improved decision-making. • Partner with Finance and Commercial teams to identify reporting needs, KPIs and performance metrics. • Design, build, and maintain interactive dashboards and reports in PowerBI to visualize trends, forecasts, and performance insights. • Develop data models and ETL (Extract, Transform, Load) processes to consolidate information from NetSuite, Salesforce, and other internal systems. • Ensure data integrity and consistency across systems by identifying discrepancies and driving resolution with relevant stakeholders. • Support monthly and quarterly business reviews with accurate and timely reporting. • Collaborate with Tech Solutions and data engineering team to enhance data infrastructure and automate data flows. • Independently identify business needs and develop data-driven solutions. • Document business requirements, data definitions, and reporting processes for transparency and scalability. • Drive continuous improvement in data quality, reporting efficiency, and analytical tools. • Attendance and punctuality are essential functions of the position. • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
• Serve as a senior technical expert in statistical programming, providing guidance across multiple studies or functional areas. • Design, develop, validate, and oversee complex statistical programming deliverables, including analysis datasets, tables, listings, and figures. • Lead the development, validation, and continuous improvement of DMC macros and programming standards. • Provide technical oversight and review of programming work to ensure quality, compliance, and consistency across deliverables. • Drive the establishment and adoption of programming standards, best practices, and process improvements. • Collaborate with biostatistics and study teams to support complex trial designs, analyses, and DMC reporting. • Independently manage and prioritize programming activities across multiple studies or initiatives. • Mentor and provide technical leadership to statistical programming staff, supporting skill development and best practices. • Contribute technical expertise to proposals, project planning, and scope discussions as needed. • Partner with IT and technology teams to support SAS environments, tools, and system validation efforts. • Provide technical oversight for programming activities supporting regulatory submissions and inspection readiness. • Ensure programming deliverables align with regulatory expectations, submission requirements, and CDISC standards. • Influence programming approaches, standards, and best practices across multiple studies or programs. • Serve as a technical escalation point for complex programming, data, or deliverable issues, leading resolution of highly complex or ambiguous challenges. • Provide expert interpretation of statistical analysis plans (SAPs), protocols, and study documents, translating requirements into programming strategy. • Champion process improvements, automation, and innovative approaches to enhance efficiency, scalability, and consistency of programming deliverables. • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
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