Vacancies at IQVIA

Job Description

RESPONSIBILITIES  

• Serve as primary point of contact for customer on data management deliverables
• Manage multiple large studies or program of studies (possibly global)
• Provide leadership and senior support to DTLs on multiple large global programs of global studies
• Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise
• Lead direct negotiations with customer, e.g., timelines, financial, process, resources
• Meet with Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables
• Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects
• Serve as the escalation point for unresolved data issues
• Ensure appropriate resources are assigned to meet project deliverables
• Create and/or review and sign-off on all data management plan (DMP) documents
• Manage service performance and provide leadership to identify root causes of issues and implement remedial actions
• Serve as Subject Matter Expert (SME)
• Provide leadership and expertise in a specific CDM task or technology
• Independently manage SOW/budget
• Independently bring process improvements and solutions to the CDM team/CDM department
• Lead a focus team or global or local best practice team
• Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES    

• Previous experience and proven competence in managing delivery of multiple global trials through full DM life-cycle (i.e. large trials of at least 1000 patients)
• Demonstrated expert data management skills and advanced knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation)
• Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently
• Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology
• Knowledge of operating procedures and work instructions and the ability to apply them in practice
• Knowledge of Good Clinical Practices and relevant regulatory guidelines
• Excellent communication, interpersonal, customer service, and teamwork skills
• Excellent organizational and problem-solving skills
• Excellent project management skills
• Ability to work independently
• Comprehensive understanding of clinical drug development process
• Ability to establish and maintain effective working relationships with co-workers, managers and customers    

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field
• Around 7 years direct Data Management experience, including 5 or more years as a CDM project lead; or equivalent combination of education, training and experience

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Role description

Key Responsibilities:

• Lead and manage health economics projects focused on diabetes and obesity, ensuring timely delivery and high-quality outcomes.
• Serve as the primary point of contact for clients, providing expert advice and guidance on health economics models and methodologies.
• Develop and implement health economic models to support the value proposition of diabetes and obesity treatments.
• Conduct literature reviews, data analysis, and interpretation to inform model development and validation.
• Present findings and recommendations to clients, stakeholders, and internal teams through reports, presentations, and publications.
• Contribute the dissemination of research findings by drafting scientific manuscripts, reports, and presentations for publication in peer-reviewed journals and conferences.
• Stay current with the latest research, trends, and best practices in health economics with a focus on diabetes, and obesity.

Qualifications:

• Advanced degree (PhD, MSc, or equivalent) in Health Economics, Public Health, Epidemiology, or a related scientific field.
• Minimum of 5 years of experience in health economics
• Experience with ex-novo HEOR models building
• Experience in the pharmaceutical or healthcare consulting industry working for HQ
• Proven experience in project management, including planning, execution, and delivery of complex projects.
• Strong analytical skills and proficiency in health economic modelling software (e.g., TreeAge, Excel, R).
• Excellent communication and presentation skills, with the ability to convey complex information to diverse audiences.
• Ability to work independently and as part of a team in a fast-paced, dynamic environment.
• Strong organizational skills and attention to detail.

Preferred Qualifications:

• Publications in peer-reviewed journals related to health economics, diabetes, or obesity.
• Knowledge of global health systems and reimbursement processes.
• Preference for experience in modelling chronic diseases

What We Offer:

• Working in an international team for top-tier customers
• Competitive salary and benefits package
• Opportunities for professional growth and development
• Collaborative and inclusive work environment
• The chance to make a meaningful impact on global health outcomes

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Job Description

• The CDM will perform scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS).

Deliverables:

• Services rendered will adhere to applicable Client SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
• Provides scientific data review support for more than one low to moderate complexity trial or one high complexity trial.
• The data management expert who, within the therapeutic area, is performing scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS). Tapping into technical and clinical expertise, closely collaborating with the SRP, SRS, Data Management functions and the rest of the study team members when implementing the data management related activities for protocols, with focus on more complex indication and therapy related elements of the study. Reviews all necessary data flows, the Data Management Plans and performs continuous (complex) data review activities on the studies in the assigned program.
• Involved in study related activities from the protocol design stage onwards, providing input into the study specific and/or indication specific data collection tools.
• Reviews (complex) scientific study data, manages CDM and SRS/SRP related queries in eDC system and holds discussions with SRS/SRP. Involvement in other review activities (e.g., Coding, SAE reconciliation) is possible. Leads and/or attends meetings as appropriate.
• Takes a leadership role with SRP/SRS and collaborates with the GDM to establish, align and confirm scientific clinical data review expectations for assigned trial(s).

With the trial customer, CRO and other functional partners in relation to CDM related activities:

• Reviews content and integration requirements for eCRF and other data collection tools
• Establishes conventions and quality expectations for clinical data.
• Set timelines and follow‐up regularly to ensure delivery of all Clinical Data Management milestones
• Creates the Integrated Review Plan ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Reviews related clinical data management documents. Ensures compliance with regulatory guidelines and documentation requirements.
• Ensures real‐time inspection readiness of all assigned deliverables for the trial; participate in Regulatory Agency inspection and Client internal audits as necessary.
• Plans and tracks applicable CDM deliverables. Ensures CDM deliverables are on time.
• Takes a leadership role in collaborating with the SRS/SRP to ensure that DM and Therapeutic Area trial needs and deliverables are met.
• Identifies and communicates lessons learned, best practices and frequently asked questions at the trial level.
• Identifies and participates in process, system, and tool improvement initiatives within clinical data management.
• Therapeutic Area - Oncology, Cardiovascular and Immunology

Education/Experience

• BS/BA degree or higher preferably in Health Sciences, or BS/BA degree or higher with professional clinical experience/exposure.
• 5 years Data management experience. Data Management experience preferably including clinical data review or significant experience with clinical data review. Knowledge in medical terminology would be preferable
• Collaboration with Clinical teams.

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Job Description

RESPONSIBILITIES  

• Serve as primary point of contact for customer on data management deliverables
• Manage multiple large studies or program of studies (possibly global)
• Provide leadership and senior support to DTLs on multiple large global programs of global studies
• Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise
• Lead direct negotiations with customer, e.g., timelines, financial, process, resources
• Meet with Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables
• Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects
• Serve as the escalation point for unresolved data issues
• Ensure appropriate resources are assigned to meet project deliverables
• Create and/or review and sign-off on all data management plan (DMP) documents
• Manage service performance and provide leadership to identify root causes of issues and implement remedial actions
• Serve as Subject Matter Expert (SME)
• Provide leadership and expertise in a specific CDM task or technology
• Independently manage SOW/budget
• Independently bring process improvements and solutions to the CDM team/CDM department
• Lead a focus team or global or local best practice team
• Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES    

• Previous experience and proven competence in managing delivery of multiple global trials through full DM life-cycle (i.e. large trials of at least 1000 patients)
• Demonstrated expert data management skills and advanced knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation)
• Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently
• Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology
• Knowledge of operating procedures and work instructions and the ability to apply them in practice
• Knowledge of Good Clinical Practices and relevant regulatory guidelines
• Excellent communication, interpersonal, customer service, and teamwork skills
• Excellent organizational and problem-solving skills
• Excellent project management skills
• Ability to work independently
• Comprehensive understanding of clinical drug development process
• Ability to establish and maintain effective working relationships with co-workers, managers and customers    

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field
• Around 7 years direct Data Management experience, including 5 or more years as a CDM project lead; or equivalent combination of education, training and experience

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Job Description

• Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster.
• The Project Lead is an essential member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies and practices.
• Clinical Project Management is focused on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction.
• Clinical Project leads can run their own studies. The Project Lead focus is on leveraging therapeutic expertise and IQVIA’s suite of solutions to drive operational excellence and strategic leadership with our customers

Essential Functions

• Participate in bid defense presentations in partnership with Business Development and may lead the presentation for smaller, less complex regional studies.
• May be responsible for delivery and management of smaller, less complex, regional studies.
• Develop integrated study management plans with the core project team.
• Accountable for the execution of clinical studies, or assigned portion of clinical studies, per contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
• Set objectives of the core project team and/or sub-team(s) according to agreed upon contract, strategy and approach, effectively communicate and assess performance.
• Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
• Monitor progress against contract and prepare/present project and/or sub-team information proactively to stakeholders internally and externally.
• Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts.
• Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and/or sub-team members and planning/implementing appropriate corrective and preventative action plans.
• May serve as primary or backup project contact with customer and would then own the relationship with the project’s key customer contacts, as well as communicate/collaborate with IQVIA business development representatives, as necessary.;
• Build the cross-functional project team and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.;
• Ensure the financial success of the project.
• Forecast and identify opportunities to accelerate activities to bring revenue forward.
• Identify changes in scope and manage change control process as necessary.
• Identify lessons learned and implement best practices.
• May be assigned as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirements.;
• Adopt corporate initiatives and changes and serve as a change advocate when necessary.
• Provide input to line managers of their project team members’ performance relative to project tasks.
• Support staff development and mentor less experienced project team members on assigned projects to support their professional development.;

Qualifications

• Bachelor's Degree Life sciences or related field
• 5 years of prior relevant experience including > 1 years project management experience or equivalent combination of education, training and experience.
• Advanced knowledge of job area, and broad knowledge of other related job areas, typically obtained through advanced education combined with experience.
• Knowledge of clinical trials - 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.

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Role Overview:

• This unique role within IQVIA lends itself to a technically minded Project Manager with strong communication skills and SDTM knowledge. Having experience with SAS programming will also be a huge benefit. The role can be based remotely from anywhere in Europe or in South Africa.
• This role is part of a sponsor dedicated project where you will be working with the client directly to manage Database Delivery from external vendors.
• The primary functions of this role will be to build study eCRFs in Formedix Ryze (Certara), define structure of datasets that are part of data transfer specifications and ensure quality and completeness of SDTM format data.

Primary Functions:

• Build study eCRFs in Formedix Ryze (Certara)
• Define dataset structures for data transfer specifications
• Ensure quality and completeness of SDTM format data

Main Responsibilities:

• Collaborate with Sponsor colleagues and CRO Partners to finalize the design, creation, and implementation of EDC solutions.
• Work with Study Data Leads to plan for data receipt and oversee it throughout clinical trials.
• Process data loads from various sources into clinical and operational data repositories, including reviewing and communicating issues.
• Program reports and contribute to the standardization of processes and reports for data review and analysis for external partners/vendors and internal teams.
• Complete formal and ad-hoc analyses and oversight of SDTM data.
• Review critical documents/deliverables (SDTM Annotation, SDTM datasets) to ensure consistent use of Data Standards and support the creation of DE datasets.
• Attend meetings with various teams (Mission, Submission, Project, Program, JCST, DEM, Biometrics, Clinical & Regulatory Solutions Team (CRST), Early Phase)
• Perform quality checks and create standard edit checks for new CRF modules.
• Support audits and inspections as required and handle other responsibilities and projects assigned by the Company.

Experience Required:

• Substantial experience in relational database design.
• Substantial experience with SAS programming preferred.

Experience with Data Management processes, including:

• Review of SDTM annotated CRFs
• Writing and reviewing technical specifications
• Reviewing log files for errors and warnings
• Resolving/troubleshooting errors
• Data mapping and SDTM Controlled Terminology.
• Prior experience in a clinical or pharmaceutical-related field.
• Prior experience in a Data Management-related field.
• Experience with relational databases, preferably Clinical Data Management and EDC Systems.
• Advanced familiarity with reporting tools.
• Advanced knowledge of federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices.
• Excellent command of English, both verbal and written.

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Job Overview

• Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Sponsor dedicated, Home Based role.

Essential Functions

• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
• Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.
• Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review and provide feedback to management on site performance metrics.
• Review, establish and agree on project planning and project timelines.
• Ensure monitoring measures are in place and implement contingency plan as needed.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.

Qualifications
Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.

• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
• Knowledge of applicable regulatory requirements, including local regulations, , SOPs and company’s Corporate Standards.
• Understanding of regulated clinical trial environment and knowledge of drug development process.