IQVIA

Research Analyst

• Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Senior Clinical Research Associate, CRA

Medical writer

• Write high-quality HEOR study reports and protocols, HTA/GVD dossiers, manuscripts, conference abstracts
• Work with senior team to co-manage small workstreams, project tasks and thought leadership initiatives
• Conduct quality control reviews of HEOR documents and maintaining audit trails of changes
• Mentor and train less experienced Medical Writers
• Contribute to medical writing training initiatives to upskill the team and set quality standards
• Support the team’s Centre of Excellence initiatives

Medical Writer – Value Dossier

Account Executive

• Initiate outbound calls to Optometrists and Ophthalmologists to deliver effective discussions about presbyopia and related clinical information.
• Deliver key insights/clinical information to physician offices by liaising with receptionists, office-managers and other office staff to get to the Eye Care Physician.
• Over-Achieve on key productivity, development, and learning objectives.
• Engage targeted ECP and office staff with clinical information and services provided in compliance with LENZ Therapeutics’ policies.
• Ensure all calls/activities are entered into CRM system at time of discussion.
• Receive inbound calls if needed during operating hours.
• Continuous self-learning of the presbyopia market including new developments and updates.

Inside Sales Representative

Consultant

• Provide case support, patient management, and education to both new and existing accounts within an assigned client Franchise/Region
• Acquire and demonstrate a working knowledge of our products/therapies and develop an understanding of their applications
• Improve patient outcomes by delivering ventricular medical device education in a variety of settings, including but not limited to, the ICU, OR, and Cath Lab
• Ventricular medical device case support, including on call support
• Complete proactive rounds for patients receiving support and provide assistance
• Collaborate with the Clinical Support Center (CSC) for ongoing additional support as necessary
• Maintain clinical competency in current product line, patient management, and remain up to date on most relevant information through continual learning and education
• Some travel may be needed

Part Time Clinical Consultant – MedTech

Director

• Define and prioritize resource requirements and manage resource assignments across projects
• Monitor and manage utilization and productivity of Functional Department
• Regularly set goals and evaluates and documents performance
• Define recruiting strategies and staffing needs based on hard backlog
• Provide expert review and guidance for production of Data Management deliverables including CRF/e-CRF (case report form), database design and set-up, validation definition and programming, Data Management Plan and database deliverables to internal and external customers
• Provide technical advice and solutions with internal and external customers to solve problems and improve efficiency
• Participate in defining strategies for new processes and technology at either regional or global level
• Ensure that staff is trained and compliant with current operating procedures and work instructions and project scope of work
• Define and implement training/professional development strategy for Functional Department
• Mentor staff members to develop Data Management process, system, and drug development expertise
• Manage relationship with customer at both the project team level and with functional peers
• Hold at least bi-monthly meetings with direct reports to discuss project status, including timelines, delivery updates, financial aspects of the group or project, and potential risks
• Create and implement plans for measuring and improving employee engagement ensuring global consistency
• Maintain open and regular communication with direct reports to ensure a supportive working environment
• Efficiently conveying messages from leadership to direct reports and teams
• Prepare, present and respond in bid defense meetings and discussions

Associate Director, Clinical Data Management

Client Partner

• Responsible for the sales of Proof Solutions
• Manage and further develop client relationships
• Identify new business opportunities
• Maintain and expand strategic partner relationships

Sales and Account Partner Specialist

Clinical Research

• Ensure the conduct of clinical trials for assigned projects in compliance with regulatory requirements...
• Ensure that project enrollment targets are met and implement appropriate recruitment strategies.
• Contribute to the development of the project risk management plan and manage clinical risks throughout the project lifecycle.
• Ensure the quality of clinical trials by identifying applicable quality standards and requirements...
• Manage the clinical aspects of project funding and related financial activities...
• Identify the project's clinical stakeholders and manage internal and external stakeholder relationships...
• Collaborate with the clinical team to achieve established objectives.
• Plan and allocate clinical team resources and talent.

Clinical Trial Manager II

Manager

• Lead a team of Internal Linguists to perform according to the expectations of their role.
• Assist Language Manager in setting goals for Direct Reports based on performance analyses.
• Achieve established KPIs by reviewing high-visibility documents for priority clients.
• Provide linguistic feedback to internal linguists on a monthly basis.
• Oversee the onboarding process of internal linguists.
• Contribute to the hiring process by reviewing tests and participating in interviews.
• Identify candidates for IL roles among External Linguists.
• Collaborate with LQS, Talent Management and Onboarding PM team on initiatives to improve quality.
• Lead initiatives to improve the quality of External Linguists and foster their engagement.
• Produce and present reports to the Language Manager and potentially to the Leadership Team.
• Identify and develop talent inside the team for succession planning.

Associate Manager, Language Management

• Ensure the execution of clinical trials for assigned projects in accordance with regulatory requirements (International Council for Harmonisation (ICH) - Good Clinical Practice (GCP), protocol), client requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).
• Ensure project enrollment targets are met and implement appropriate recruitment strategies.
• Contribute to the development of the project risk management plan and manage clinical risks throughout the project lifecycle.
• Ensure the quality of clinical trials by identifying quality standards and requirements, planning compliance assessment activities, and tracking and managing clinical quality issues.
• Manage clinical aspects of project financials, including Estimate at Completion (EAC). Understand the scope of clinical deliverables and develop plans for their implementation. Monitor and manage variances relative to the baseline EAC and identify opportunities for additional services or out-of-scope work.
• Identify project clinical stakeholders and manage internal and external stakeholders through effective communication and rigorous issue management.
• Collaborate with the clinical team to achieve objectives. Report to internal and external stakeholders in accordance with project requirements.
• Plan clinical team resources and talent.

Senior Clinical Trial Manager, IQVIA Biotech

Pricing Analyst

• Responsible for developing and analyzing fair market value (FMV) pricing for clinical trial agreements.
• Provide support to the clinical team in budgeting, pricing, planning, execution, and control of grants and contracts.
• Ensure all services adhere to applicable company SOPs, WIs, policies, and local regulatory requirements.
• Analyze pricing requests/needs from operating companies and translate them into appropriate budgets/contract exhibits.
• Assess investigator grants for FMV aligned with regional knowledge and company pricing guidelines.
• Participate in and/or lead the budget escalation review process.
• Provide guidance to CROs contracted to negotiate clinical agreements globally.
• Identify needs for budget revisions and related contract amendments.
• Mentor and train new pricing assistants, pricing analysts, and site contract managers as needed.

Senior Pricing Analyst – Sponsor Dedicated

• Oversee study monitoring plan compliance for assigned studies
• Serve as the primary point of contact for IQVIA CRAs
• Provide oversight of site monitoring data management activities
• Review Monitoring Visit Reports and provide guidance
• Prepare and lead regular meetings with IQVIA CRA and sponsor Project Manager
• Collaborate and liaise with sponsor Project Manager for project execution support
• Support CRA with study issue resolution

Senior Clinical Research Associate – Lead CRA

• Responsible for the development of complex investigator grant estimates
• Develop contract and budget templates and contracting systems, tools, processes, and training materials for selected sponsors and complex studies or multi-protocol programs
• Ensure collaboration, including communication with sponsors, stakeholders and RSU regions and countries
• Provide specialist legal, operational and financial contracting support to the study teams
• Create, publish and/or review core scientific, technical and administrative documentation
• Assess and review the contracting landscape and contribute to the collection, interpretation, analysis and dissemination of accurate contracting intelligence
• Ensure overall contracting efficiency and adherence to project timelines and financial goals
• Report contracting performance metrics and out of scope contracting activities
• Work with Quality Management to ensure appropriate contract management and quality standards
• Mentor and coach colleagues as required
• Deliver presentations to clients and professional bodies as required
• Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans
• Take a lead role in developing long standing relationships with preferred IQVIA clients/customers.

Senior Site Contract Manager

• Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies
• Oversee the execution of Site Activation and/or Maintenance for assigned projects
• Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan
• Ensure collaboration across Regulatory & Site Activation
• Create and/or review technical and administrative documentation
• Provide specialist regulatory and technical scientific support
• Provide overall guidance and oversight of multi-regional and multi-protocol programs
• Identify regulatory complexity and challenges
• Assess and review the regulatory landscape
• Execute operational strategy/ expectations for maintenance of clinical study approvals
• Mentor and coach colleagues as required

Local Study Associate Director – FSP

Account Manager

• Responsible for promoting a product to specialty healthcare providers in an assigned territory

Key Account Representative

• Lead complex consulting projects in the areas described above (e.g., sales organization design, optimization of customer segmentation) for our pharmaceutical clients and clients in related industries (e.g., medical devices) at national and international levels, acting as the primary point of contact for client inquiries.
• Lead our project teams, potentially cross-disciplinary, from kickoff through successful project completion.
• Present project results to clients and facilitate workshops.
• Ongoing project controlling, including reporting, to support our internal finance processes.
• Provide partial support for business development, including concept development, proposal preparation and costing, and participation in client meetings in collaboration with the responsible Principal and Key Account Management.
• Develop and refine our consulting approaches and methodologies in conjunction with our IQVIA data and analytical tools, and support thought leadership activities (e.g., contributing to publications).
• Lead and participate in internal workstreams to further develop our team and organization, for example Training & Development.