IQVIA

• Provide advanced technical expertise to develop process methodology for the department to meet internal and external clients’ needs, across complex projects and studies. • Planning and coordinating the development of integrated programming solutions. • Performing, planning co-ordinating, and implementing programming, testing, and documentation of statistical programs for complex studies. • Communicating with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines. • Estimating programming scope of work, managing resource assignments, and communicating project status. • Using and promoting the use of established standards, SOP and best practices. • Providing training and mentoring to SP team members.

Title: Safety Associate Location: Durham, North Carolina, United States of America Job Description: Job Overview: Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members. Essential Functions: - To Prioritize and complete the assigned trainings on time. - Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements. - To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information determining initial/update status of incoming events database entry coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines. - Creating, maintaining and tracking cases as applicable to the project plan. - Identify quality problems, if any, and bring them to the attention of a senior team member. - To mentor new teams members, if assigned by the Manager. - Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes. Qualifications: - High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences background with 1-1.5 years of relevant experience. - Good knowledge of medical terminology. - Working knowledge of applicable Safety Database (ARGUS). - Good working knowledge of Microsoft Office and web-based applications. - Ability to multi-task, manage competing priorities and deadlines. - Willingness and aptitude to learn new skills across Safety service lines. - Ability to work as a Team Player, contribute and work towards achieving Team goals. - Ensure quality of deliverables according to the agreed terms. - Use of telephone and face-to-face communication requiring accurate perception of speech. - May require occasional travel. - May require on-site work (in a hybrid capacity, 1 day a week) IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. The potential base pay range for this role, when annualized, is $44,900.00 - $112,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

Role Description Associate Decentralized Clinical Trial Study Lead (aDCTL) / Decentralized Clinical Trial Lead (DCTL) are an integral part of clinical trial delivery to improve patients’ lives and bring therapies to the market faster. The aDCTL / DCTL roles requires strong project management skills, customer and site facing engagement experience, creativity/innovation and the ability to thrive in a dynamic setting. The aDCTL / DCTL may oversee studies ranging from fully decentralized trials to hybrid studies which require liaising with traditional project delivery teams. Critical to the success of DCT is the ability to collaborate across multiple teams and stakeholders including but not limited to technology & IT, mobile nursing, site support services, regulatory, site startup, etc. aDCTL / DCTL’s also follow established SOP and policies focused on project delivery, productivity and quality resulting in strong project financial performance and customer satisfaction. - Accountable for the strategic development and delivery of DCT studies in line with agreed upon contracts while optimizing speed, quality and cost of delivery. - Serve as DCT project oversight and/or contact with customers and own relationship with the project’s key customer contact(s). - Set objectives and manage for the DCT project team according to agreed upon contract, strategy and approach for operational delivery. - Collaborate with other functional groups within the company where necessary to develop and/or support the preparation of integrated study management plans. - Monitor progress against contract and prepare/present project information proactively to all stakeholders internally and externally. - Supervise problem solving and resolution efforts to include management of risks, and manage contingencies and issues. - Achieve project quality by identifying and proactively managing quality risks and issues. - Take ownership, understand the budget and drive optimal project financial management from initial load to study closeout. - Ensure the financial success of the project including optimal management and assignment of resources. - Actively work on preserving DCT scope and forecast opportunities to accelerate activities. - Identify changes in scope and manage change control process. - Identify and communicate lessons learned and best practices to promote continuous improvement. Qualifications - Bachelor's Degree in Life sciences or related field. - Requires +4 years relevant clinical research experience plus around 3 years of experience in project management. - Requires advanced knowledge of and experience implementing Project Management methodologies, ideally within the clinical research space. - Broad knowledge of DCT (current challenges and opportunities to improve clinical trial delivery) and other related job areas. - Knowledge of clinical trials and applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws. - Technology Savvy – Affinity for learning and leveraging technology. - Strong written and verbal communication skills including good command of English language. - Good understanding of project financials including experience managing financials (budget), contractual obligations and implications. Company Description IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

Role Description We are currently looking for an Inside Sales Representative to join our team. In this position, you will promote a product specific to the GI Space. The Inside Sales Representative is primarily responsible for achieving sales forecast and gaining adoption and utilization of the product portfolio. This is accomplished by establishing mutually beneficial business relationships with targeted accounts and physicians key to the sales success of the promoted products. The sales representative is also responsible for coordinating sales strategies with appropriate teammates to maximize sales in assigned territory. - Initiates and answers inbound and/or outbound sales calls or electronic inquiries directly from/to prospective and/or existing customers. - May also be involved in order fulfillment, post-sales or administrative related activities. - Responsible and accountable for the achievement of sales versus assigned quota. - Has general awareness of business, products/services and the market. - Has very limited authority/opportunity to set and negotiate product/service terms. - Relies on manager to provide planning and manage resources. - Resolves routine issues. - Works on problems of limited scope. - Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained. - Builds stable working relationships internally. - Builds strong relationships with all external customers. Qualifications - Bachelor’s degree (BA/BS) from an accredited college/university required. - 1-3 years of inside sales experience preferred. - 1-2 years of Pharmaceutical experience preferred. - Demonstrated success selling in a remote only environment. - Proven ability to identify, engage and influence key discussions with physicians. - Ability to interact with all levels of an office including clinical discussions with prescribers. - Ability to successfully complete all product training tests and certifications. - Proven track record of success in a competitive environment with documented performance a strong plus. - Demonstrated impactful presentation skills. - Experience developing and maintaining customer relationships. - Experience with Salesforce, Veeva preferred. - Ability to understand and convey accurate complex product-related information to Healthcare Professionals, in an educated, reassuring, and professional manner. - Ability to accept and quickly apply coaching and feedback to improve individual performance and customer experience. - High work ethic, reliable and punctual in reporting for scheduled work. - Ability to be flexible as needed to meet the fluctuating business needs. - Maintain and update current and prospective target Prescriber profiles. - Plan and organize Territory to meet sales and call targets. - Make complete, accurate and timely submission of all time keeping, Details, call activity, within the approved CRM. - Compliance with Promotional Program, and proper use of Promotional Materials and Promotional Expense Budgets. Company Description IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

Role Description Perform daily administrative activities for innovation area, to support the improvement of clinical trials processes. - Support global upper management with optimizing monitoring, start up, close-up, SOPs process. - Collaborate on the preparation of presentations, schedule meetings, inform consents review according to the scope of work and standard operating procedures. - Assist with the improvement of processes with AI and process diagrams. - Manage presentation platforms (such as Monday & Canva). - Act as a central contact for the assigned client director for designated project communications, correspondence and associated documentation. - Act as a mentor for less experienced Clinical Process Assistants (CPAs). - Assist with training and onboarding of new CPAs. - May serve as subject matter expert for business processes. - May participate in departmental quality or process improvement initiatives. Qualifications - Preferred background in life-science or health-care related qualification or equivalent work experience. - Previous administrative experience is desired. Clinical related experience in a medical profession, pharmaceutical, or diagnostic company is preferred. - Ability to manage multiple projects and prioritize appropriately. - Ability to develop, lead and conduct training activities for new and current staff. Serve as mentor as needed. - Proficient in application of the conduct of clinical trials and its associated activities and responsibilities. - Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint. - Effective written and verbal communication skills including good command of English language. - Demonstrate consistent critical thinking and problem solving methodologies. - Ability to establish and maintain effective working relationships with coworkers, managers, and clients. - Preferred with a proven track record of success and a basic knowledge related to ICH/GCP Guidelines and applicable local regulations. Company Description IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

Role Description We are seeking a Freelance Site Feasibility Specialist to support the successful identification and selection of investigator sites across Europe. This role is highly operational and site-facing, focusing on feasibility outreach, data collection, and tracking, while ensuring high standards of communication, organization, and confidentiality. You will work closely with internal study teams and external sites to gather key information that supports efficient study start-up and site selection. Key Responsibilities - Conduct site-facing outreach to investigators and study sites across Europe - Distribute feasibility questionnaires and follow up to ensure timely responses - Act as a key point of contact for feasibility-related communication - Support the collection of feasibility data (SSQ, site information, etc.) - Track responses and maintain accurate records in internal systems - Ensure timely reporting of feasibility status to stakeholders - Assist with data entry and monitoring of feasibility responses - Coordinate and support the collection of Confidentiality Disclosure Agreements (CDAs) - Ensure proper tracking and documentation of all agreements - Maintain compliance with internal processes and timelines - Maintain clear and professional communication with sites and internal teams - Collaborate with study start-up, site identification, and project teams - Provide regular updates on feasibility progress and any challenges Qualifications - Experience in: Clinical research (CRO, pharma, biotech) - Minimum of 2-3 years in site feasibility, site ID, or study start-up - Strong organizational and tracking skills - Excellent communication skills (written and verbal) - Experience working with: Feasibility questionnaires (SSQ) and CDA collection processes - Ability to manage multiple sites and timelines simultaneously - Fluent in English (additional European languages are a plus) Requirements - Experience in clinical research (CRO, pharma, biotech) - Minimum of 2-3 years in site feasibility, site ID, or study start-up - Strong organizational and tracking skills - Excellent communication skills (written and verbal) - Experience with feasibility questionnaires (SSQ) and CDA collection processes - Ability to manage multiple sites and timelines simultaneously - Fluent in English (additional European languages are a plus) Benefits - The potential base pay range for this role, when annualized, is zł105,900.00 - zł196,600.00. - The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). - Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

Role Description As the Event Project Support Specialist, you will have some experience in supporting projects with a keen eye for managing and analyzing reports and data to include rooming lists, transfer manifests, expenses and other event related activities. You will be responsible for a range of activities to support the successful project management and delivery of live Events for a variety of Clients. You will collaborate with and work alongside Event Project Managers to deliver projects on time, to scope and within budget. You will monitor progress, address delays, reconcile and organize project data keeping a range of stakeholders up to date and informed. This position is home based in collaboration with a global team at IQVIA and with our clients and healthcare professionals. - Interacting and developing relationships with Clients, Suppliers and IQVIA stakeholders on a regular basis to support project deliverables - Supporting with the financial reconciliation of deliverables to provide paperwork and invoices as necessary for expenses incurred on projects - Working with the Event Project Management Team to support them with the review and analysis of reports and data - Supporting with project timelines to ensure deadlines are met and project plans are updated - The maintenance of internal databases and trackers in accordance with project delivery SOP’s - The management and set up of all project documentation, files and templates, including ongoing audit of existing documents - Supporting with travel approvals to ensure attendee requests are in accordance with compliance - Occasionally supporting with the onsite delivery of Events to include the management of attendees, their transport, accommodation, and associated Event materials - Supporting with the onboarding and training of new hires into the Event Management Team - This position will require occasional global travel to support the onsite delivery of live Events Qualifications - Bachelor's Degree in any discipline. Hotel management is preferred. - At least 2 years of proven experience in administrative support, project coordination, or operational support roles, preferably in hotel management, hospitality, or travel agency environments. - Candidates from all industries are welcome; prior healthcare or life sciences industry experience is preferred. - Proficient in computer skills, including MS Office applications. - Strive to provide quality customer service and have exceptional attention to detail. Requirements - Good communicator with the ability to build strong professional relationships internally and externally - Good problem-solver to investigate challenges and find solutions - Self-directed with the ability to work independently - Organised and able to prioritise and meet deadlines - Strong software and computer skills, including MS Office applications especially Excel - An enthusiasm for organising data and reports - Experience in working with external vendors and suppliers Company Description IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

Role Description The Medical Director will be the medical expert on the IQVIA team working on clinical research trials in neurological diseases and disorders. This involves applying medical and scientific knowledge and expertise in support of the trial. These clinical trials will cover the full range of neurologic disorders. Essential Functions - Medical Monitoring responsibilities with Medical Strategic input involvement as requested. - Primarily serves as Medical Monitor (at the global or regional level) on assigned clinical trials. - Serves as Scientific Advisor (providing medical advice and input) to Project Leaders on the medical and scientific aspects of assigned projects. - Provides medical support to investigative sites and project staff for protocol-related issues including determining if subjects are eligible to participate in given clinical trials. - Provides therapeutic area/indication training for the project clinical team. - Attends and presents at Investigator Meetings. - Performs review and clarification of trial-related Adverse Events (AEs). - Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested. - Responds to urgent protocol-related issues at investigative sites. Medical Strategy - Contributes to the development of the medically-related aspects of client proposals including the budget related to medical monitoring. - Provides medical and scientific advice and guidance to key internal stakeholders developing proposals: this may include reviewing the protocol for scientific/regulatory soundness and feasibility, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape. - Attends and presents at bid defense meetings, as required. - Requires 5-10 % periodic regional and international travel. Qualifications - Medical degree from an accredited and internationally recognized medical school. - Board certified or eligible in Neurology. - Ideally candidate will have a minimum 2 years clinical trials experience as an investigator or medical/clinical expert in the Pharma, CRO, or Biotech industry. - Ability to establish and maintain effective working relationships with coworkers, managers and clients. - Strong communication, presentation and interpersonal skills, including good command of English language (both written and spoken). - Robust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in Neurology. - Proven skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility. - Availability for intermittent domestic and foreign travel to support these business assignments. - Subspecialty interest and training in neuromuscular diseases (ALS, myasthenia gravis, neuropathy), or sleep disorders, or pediatric neurology is a plus, but not required. - Has the skill, knowledge, and training necessary to provide medical monitoring for the full range of neurological diseases/disorders. Benefits - The potential base pay range for this role, when annualized, is $154,900.00 - $431,500.00. - The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). - Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

Scientific Advisor, Director Location: Austin United States Full time R1555005 Remote Job Description: We are seeking Scientific Advisor, Director to join IQVIA Laboratories at Austin, TX (Remote). We hire passionate innovators who drive healthcare forward through thoughtful and inclusive collaboration. If you want to discover a career with greater purpose, join us as we transform and accelerate research and development. Job Summary: The Scientific Advisor, Director provides scientific leadership for protein biomarker programs supporting translational research, clinical development, and drug development initiatives. Serving as a key partner to clients, business development, and internal teams, this role develops fit-for-purpose biomarker strategies, evaluates emerging technologies, and helps translate scientific opportunities into practical study solutions. The successful candidate will possess deep expertise in protein biomarker technologies, including multiplexed applications, strong client-facing communication skills, and the ability to work effectively across business development, laboratory operations, quality, data sciences, and R&D. This is a primarily remote position with initial onboarding in Austin, Texas, and periodic travel as needed for client, conference, and business activities. What You'll Be Doing: - Lead biomarker strategies for translational and clinical studies, including panel selection, study design considerations, and assay or platform recommendations aligned to program objectives - Serve as the scientific lead for protein biomarker programs by engaging clients, translating complex technical concepts into practical study plans, and helping move opportunities across the finish line - Support business development through technical marketing materials, white papers, scientific content, and proposalstrategiesthat align scientific design with commercial goals - Evaluate existing and emerging protein biomarker technologies and recommendsolutions across platforms such as Luminex, Simoa, MSD, Olink, and newer technologies including Alamar - Build externalvisibilitythrough publications, presentations, conference participation, consortium engagement, and scientific partnerships that reinforce IQVIA Laboratories' leadership in protein biomarker profiling - Drive specialty laboratory, biomarker, and technology strategy as a senior individual contributor, influencing scientific direction, platform investments, service portfolio development, and growth opportunities across the organization. What We Are Looking For: - PhD or Master's degree in immunology, molecular biology, translational science, or related field - ~10+ years of experience inclinical laboratory services, CRO environments,drug developmentor equivalent experience - Deep expertise in multiplex and ultra-sensitive immunoassays and their application in translational research, ideally with experience in protein assay development and a prior laboratory background - Experience with platforms such as Luminex, Simoa, MSD, Olink, and emerging technologies The Knowledge, Skills and Abilities Needed for This Role: - Strong client-facing communication and presentation skills, including the ability to speak credibly with biopharma partners, leadership teams, and other senior stakeholders on complex scientific topics - Ability to connect biological hypotheses to practical assay strategies, identify disease-relevant biomarkers, critically assess new technologies, and distinguish strong scientific recommendations from weak ones - Proven ability to lead complex cross-functional initiatives, influence without direct people management, build networks in the protein biomarker space, and operate successfully as a strategic individual contributor What We Offer You: We put our employees at the center of everything we do and are committed to providing them, and their families, with benefits that meet their diverse and changing needs. We invest in integrated benefits programs and resources to take care of our employees' physical, mental and emotional, financial and social well-being so they can thrive at home and at work, at any stage of their well-being journey. To learn more about our benefits, visitIQVIA Benefits. If you're looking to unleash your potential, join IQVIA Laboratories to help make the extraordinary possible! IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. The potential base pay range for this role, when annualized, is $134,300.00 - $374,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

Role Description The Leader of the Centralized Monitoring team partners with the project and clinical lead to achieve the delivery of the project’s overall objectives to the sponsor’s satisfaction per contract, while optimizing speed, quality, and cost of delivery in accordance with IQVIA SOPs, policies, and practices. - Leadership activities: - Leader of the Centralized Monitoring team, partnering with the project and clinical lead to perform oversight on clinical deliverables on global assigned projects as per the protocol, SOPs, respective regulations/guidelines, and project Clinical Operations Plan. - Unblinded Clinical Lead, including IP management for the assigned study to identify risk and propose mitigation (including re-supply, re-labelling, import/export licenses, etc.). - May act as Clinical Lead when not assigned to the study and at project close out. - Manage project resources (CRAs/Central Monitors/Clinical Trial Assistants/Centralized Monitoring Assistants). - Analytical activities: - Manage, monitor, and complete study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plan, review, triage and action clinical study alerts, monitor clinical operation plan compliance, etc.). - Contribute to developing the study-specific analytics strategy and work on developing advanced analytics. - Support project management team to develop monitoring strategy, including monitoring triggers/thresholds. - Attend study team and/or client meetings. - Provide inputs to clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections. - Development and use of study management plans, and/or RBM specific tools and templates, and/or other study specific plans to evaluate the quality and integrity of the study. - Ensure complete and accurate documentation of all the study specific tools and templates and keep the project audit ready, including eTMF oversight. - Mentor or coach junior staff. Qualifications - Bachelor's degree in life sciences or related field. - +3 years of relevant clinical monitoring experience (as remote or on-site CRA). - Advanced knowledge of clinical trial conduct and skill in applying applicable clinical research regulatory requirements; i.e., ICH GCP and relevant local laws, regulations, and guidelines, towards clinical trial conduct. - +2 years in a Lead role. - Strong written and verbal communication skills including advanced command of English (Mandatory). - Strong organizational, problem-solving, and decision-making skills. - Results and detail-oriented approach to work delivery and output. - Excellent motivational, influencing, negotiating, and coaching skills. - Ability to work on multiple global projects and manage competing priorities. - To lead team and effectively work in team. Company Description IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com .