Lifelancer

Project Manager

• Serve as the Project Lead and primary sponsor contact
• Accountable for overall project delivery, including quality, time, and cost
• Establish and communicate customer expectations to the project team
• Ensure internal and external escalation pathways are followed
• Delineate responsibilities and communication pathways for secondary project leads, vendors, or delivery subsets when required
• Ensure financial stewardship through contract understanding, resource alignment, out-of-scope activity management, change-order negotiations, and timeline execution
• Lead the cross-functional project team to meet or exceed deliverables
• Drive risk identification and issue resolution at the project level using RBQM/RESOLVE
• Ensure compliance with organizational policies, SOPs, ICH-GCP, regulatory requirements, and project-specific requirements

Consultant

• Provide post-go-live consulting and administrative support for multiple clients
• Configure enhancements for live applications, including business processes, taxonomy and metadata, new features and functionality, security, and notifications
• Perform bulk imports, exports, and updates of content and data
• Recommend application features, usage approaches, and best practices
• Maintain production and sandbox environments
• Create reports and dashboards
• Provide ongoing professional services for customers using Veeva’s commercial and medical content management solutions
• Participate in customer-facing consulting without routine travel

Managed Services Consultant – Commercial Vault

Clinical Research

• Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with approved protocols
• Communicate with medical site staff, including coordinators, clinical research physicians, and site staff
• Verify investigator qualifications, training, resources, facilities, laboratories, equipment, and staff
• Verify medical records and research source documentation against case report form data
• Inform site staff of entry errors and ensure good documentation practices
• Communicate protocol deviations according to SOPs, GCP, and applicable regulatory requirements
• Verify that investigators enroll only eligible subjects
• Review regulatory documents
• Manage investigational product/drug accountability and inventory
• Verify and review adverse events, serious adverse events, concomitant medications, and corresponding illnesses for accurate protocol-compliant reporting
• Assess site patient recruitment and retention and offer improvement suggestions
• Complete monitoring reports and follow-up letters summarizing findings, deviations, deficiencies, and recommended compliance actions
• Participate in clinical research departmental core rotations and drug/device development training

Senior Clinical Research Associate – Remote

• Provide post-go-live consulting and administrative support for multiple clients
• Configure enhancements for live applications, including business processes, taxonomy and metadata, new features and functionality, security, and notifications
• Perform bulk imports, exports, and updates of content and data
• Recommend application features, usage, and best practices
• Maintain production and sandbox environments
• Create reports and dashboards
• Provide customer-facing, non-travel managed services for customers using Veeva commercial and medical content management solutions

• Provide post-go-live consulting and administrative support for multiple clients
• Configure enhancements for live applications, including business processes, taxonomy and metadata, features and functionality, security, and notifications
• Perform bulk imports, exports, and updates of content and data
• Recommend application features, usage, and best practices
• Maintain production and sandbox environments
• Create reports and dashboards
• Support customers using Veeva’s commercial and medical content management solutions, including Vault PromoMats and Vault Medical

• Conduct site qualification, initiation, interim monitoring, site management, and study close-out visits
• Mentor and guide less experienced CRAs and site staff
• 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
• Assist sites with data query resolution
• Provide updates for site-related documentation for filing in the Trial Master File
• Ensure site compliance with investigational product receipt, accountability, and return or destruction
• Conduct accompanied site visits for assessment or training of other CRAs

Senior Clinical Research Associate

• Lead the quantitative analysis workstream for projects of moderate complexity
• Develop and review analysis plans, output shells, output specifications, programming requirements, statistical outputs, and technical reports
• Apply advanced statistical methods to clinical outcome assessment and patient-reported outcomes data
• Interpret results for internal teams and clients
• Communicate methodological choices to support decision-making
• Contribute to regulatory- and payer-relevant evidence generation, endpoint strategy, and scientific communication
• Build relationships with clients and cross-functional internal teams
• Contribute to proposals, bid defenses, and business development activities
• Assist in managing workstream objectives, timelines, and deliverable quality
• Mentor junior team members and contribute to training, standards, and process improvement

Senior Consultant, Statistics and Psychometrics

• Lead the quantitative analysis workstream for projects of moderate complexity
• Ensure high-quality, timely, and scientifically sound delivery
• Develop and review analysis plans, output shells, output specifications, programming requirements, statistical outputs, and technical reports
• Apply advanced statistical methods to COA/PRO data
• Interpret results for internal teams and clients
• Communicate methodological choices to support decision-making
• Contribute to regulatory- and payer-relevant evidence generation, including endpoint strategy and scientific communication
• Build working relationships with clients and cross-functional internal teams
• Contribute to proposals, bid defenses, and business development activities
• Assist in managing quantitative analysis workstream scope, objectives, timelines, and deliverable quality
• Mentor junior team members
• Contribute to team capability building, training, standards, and process improvement

General

• Perform remote site monitoring and management activities for assigned projects
• Support clinical monitoring teams in implementing study strategies, initiatives, processes, and standards
• Support collection of data and report generation for recruitment plans, enrollment, drug supply status, site payment status, and other clinical trial tracking
• Support data risk assessments as assigned
• Support monitoring teams throughout the study, including communication with clinical site institutions as appropriate
• Support document collection, visit preparation, study data review, and central monitoring activities as assigned
• Follow Standard Operating Procedures, regulatory requirements, ICH and GCP guidelines, and study-specific plans
• Perform other duties as assigned

Senior Central Monitor

Associate

• Arrange and track system access for project team members
• Maintain and quality audit project portals to ensure the most recent document revisions are available
• Assist with preparation and shipment of clinical trial documentation, including Investigator Site File
• Maintain version control and quality control of project documentation
• Submit project documentation to the trial master file
• Track and maintain project-related information, including site medical question and answer logs
• Provide administrative and project tracking support to the clinical project team
• Ensure assigned project tasks are performed timely and accurately

Clinical Trials Associate

Director

• Provide strategic leadership and technical expertise to the Data Management department
• Establish the optimal operational framework to deliver high-quality Data Management work within agreed timelines
• Provide global leadership across multiple sites and countries, including strategic direction and change management
• Develop strategies for Data Management and Database Programming systems and resource needs
• Oversee departmental efficiency using quality and efficiency metrics and customer feedback
• Monitor departmental budgets and project PPRs, ensuring adherence to trial budgets and timelines
• Allocate staff and delegate responsibility according to expertise
• Supervise, coach, mentor, and conduct performance appraisals and development reviews
• Identify departmental training requirements and provide or source training
• Advise on general and project-specific Data Management issues
• Design solutions meeting Data Management, clinical trial management, and clinical data requirements
• Liaise with technology and scientific/medical colleagues
• Act as point of contact and escalation for Sponsor personnel
• Ensure departmental SOPs and non-project procedures are written and updated
• Ensure compliance with Good Clinical Practice guidelines, SOPs, and Sponsor requirements
• Support Business Development activities, bids, proposals, and Bid Defence meetings
• Provide technical Data Management advice to other departments
• Represent Data Management capabilities within Worldwide
• Cooperate with Sponsor and regulatory authority auditors and implement recommendations with senior management

Senior Director, Data Management

Affiliate Manager

• Advise, formulate, and deliver people strategies for the region and countries to support business unit goals
• Serve as local employment-practices expert and identify and resolve labor-market issues
• Advise leaders on culturally appropriate talent strategies within countries
• Ensure consistent application of employee total-reward packages in country
• Monitor regional engagement and advise leaders on strategies to address gaps
• Evaluate, develop, and manage human-resource policies, strategies, and initiatives
• Partner with leaders and managers on change-management initiatives
• Support talent-management planning, including recruitment, employee relations, training, compensation, benefits, and other HR issues
• Use data metrics to deliver programs enhancing performance and productivity
• Manage performance actions, including PIPs, disciplinary actions, terminations, and redeployment
• Guide performance-management systems and coach managers
• Manage recruitment for Director-level positions and below with Talent Acquisition and business partners
• Define role requirements, assist with selection, and set salary offers
• Support and coach managers and employees in resolving concerns and issues
• Contribute to HR projects and policy development
• Collaborate with the global People team

Associate Regional Partner – Argentina/Mexico

Clinical Specialist

• End-to-end management of global investigator payments for assigned studies
• Collect information from all teams, systems, and tools as needed on a timely and proactive basis
• Understand global contract terms, budgets, and payment schedules to ensure payments to investigative sites align with the Clinical Trial Agreement
• Analyze and present data for various stakeholders
• Act as a liaison between investigative sites, clinical research teams, and other functional leaders
• Perform payment reconciliations at mandated intervals
• Complete analysis of budgeted versus actual spend and review findings with the project team
• Develop and provide budgetary forecasts related to investigator payments
• Develop and distribute consolidated monthly payment reports detailing paid and unpaid sites
• Participate in client and project team meetings
• Prepare for, participate in, and follow up on audits and inspections
• Participate in required and applicable training
• Serve as the point of contact for investigator-related queries
• Identify trends in underpayments and overpayments
• Evaluate trends and work toward resolution and improvement of revenue cycle processes
• Collaborate with financial and clinical departments
• Research and identify payment discrepancies
• Provide customer service to internal Worldwide Clinical Trials teams and external sites and sponsors
• Perform other duties as assigned

Clinical Payments Specialist

Compliance

• Execute strategic labeling for one or more products at the global label level or across multiple ROW countries/regions
• Ensure compliance with labeling governance requirements and associated business processes
• Lead label working groups
• Represent labeling at senior labeling governance meetings
• Develop and maintain global product labeling, including company core datasheets, major-market labels, ROW market-specific labels, packaging components, and target label profiles
• Contribute to labeling strategy
• Advise stakeholders on regulatory labeling requirements for quality, preclinical, and clinical data
• Oversee health authority interactions regarding labeling across products or ROW markets
• Manage responses to questions, negotiations, and inspections
• Potentially take responsibility for specific business processes
• Potentially develop and manage a TLP with guidance

Regulatory Labeling Associate Director

• Adhere to pharmacovigilance regulatory reporting processes and instructions
• Monitor scheduled expedited and non-expedited ICSR submissions and safety partner exchanges daily
• Execute monthly ICSR reconciliation reports with PV clients and safety partners
• Assist with testing gateway-to-gateway submissions to health authorities and ICSR exchanges
• Assist with creation and closeout of submission-related deviations and associated CAPAs
• Generate multi-tenant Argus-based line listings and summary tabulations for Periodic Safety Reports
• Assist with generation and verification of custom periodic reporting reports
• Assist with setup and verification of Periodic Safety Report requirements for health authorities
• Assist the pharmacovigilance management team with coordinating, developing, and maintaining pharmacovigilance reporting services
• Perform performance qualification testing for multi-tenant Argus upgrades, patches, and custom projects
• Execute process and documentation updates for new territory-specific and custom E2B profiles
• Perform Submissions-based PQ testing for data migration imports involving the multi-tenant Argus database

Project Manager

Managed Services Consultant – Commercial Vault

Senior Clinical Research Associate – Remote

Managed Services Consultant – Commercial Vault

Managed Services Consultant – Commercial Vault

Senior Clinical Research Associate

Senior Consultant, Statistics and Psychometrics

Senior Consultant, Statistics and Psychometrics

Senior Central Monitor

Clinical Trials Associate

Senior Director, Data Management

Associate Regional Partner – Argentina/Mexico

Clinical Payments Specialist

Regulatory Labeling Associate Director

Pharmacovigilance Specialist, Submission