Job Openings at IQVIA

Job Description

• IQVIA South Africa has an exciting opportunity available for a Strategic Relationship Manager in the data supply team. The Manager will beresponsible for maintaining and enhancing relationships with assigned data supplier accounts such as wholesalers, hospital groups, Pharmacy groups etc.
• The individual will manage relationships with various suppliers to deliver agreed upon data. Ensures supplier data quality meets standards and established expectations and consults with suppliers to provide and sell-back insights gained from supplied content.

Essential Functions

• ·Typically interfaces with the executive level at existing and prospective data suppliers to engage decision makers and discuss their business needs to develop the appropriate solutions.
• ·Utilizes existing and potentially new, sales, prescription, and patient data within assigned and new accounts to achieve assigned supplier contract goals.
• ·Delivers business solutions through IQVIA products and services to offset traditional panel costs.
• ·Anticipates clients’ needs and, in collaboration with supplier management, business development staff, develops and presents proposed solutions to client's complex business issues.
• ·Identifies and leads the pursuit of the targeted new business and contract expansion opportunities within assigned supplier(s).
• ·Leads negotiations in renewing multi-year contract(s) within assigned supplier accounts.
• ·Represents the company to the client and the client to the company.
• ·Monitors client satisfaction with contracted deliverables and works with directors within the function to achieve and maintain a high level of customer satisfaction.
• ·Effectively manages renewals and information allowances.
• ·As required, may participate in contract renewal efforts on large multi-year contracts.
• ·May act as advisor on marketing, market research, sales management, industry issues, trends and IQVIA product and consulting capabilities.

Qualifications

• ·Bachelor's Degree Required
• ·Five (5) years directly related experience within pharmaceutical market, logistical supply chain environment and consumer health environment.
• ·Strong customer account management and servicing, communication and listening, organizational, analytical/problem solving, negotiating, and account development & planning/presentation skills.
• ·Ability to manage multiple priorities.
• ·Strong business knowledge.
• ·Market research method/practice knowledge.
• ·Expertise and creativity to solve problems.
• ·Able to lead teams in an effective way.

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Job Description

Job Overview

• IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas. agile structure, collaborative culture, and deep therapeutic expertise allow us to deliver tailored solutions that help bring innovative treatments to patients faster.
• The Clinical Project Coordinator supports, with minimal supervision, the Project Leader (PL) and Clinical Project Manager (CPM) with project management activities to ensure all work is conducted in accordance with standard operating procedures (SOPs), policies and practices, good clinical practices (GCP), applicable regulatory requirements, and meets quality/timeline metrics. Ensure customer satisfaction is met in relation to assigned project/s.
• Working hours are anticipated to be either 11:00 AM–8:00 PM (including a 1-hour break) or 11:30 AM–8:00 PM (including a 30-minute break). The exact schedule will be confirmed before your start date.

Essential Functions

• Assist in the establishment and maintenance of all project documentation including all files, records and reports according to the scope of work and standard operating procedures (SOPs).
• Assist with periodic review/audit of files for accuracy and completeness.
• Assist with the coordination and tracking of all information, communications, documents, materials, and supplies for assigned projects.
• Manage study specific eTraining and oversee compliance.
• Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information.
• Prepare and distribute status, tracking and project finance reports, and assist the project manager(s) with budget allocation and approval of invoices.
• Organize and support project leader (PL) in managing internal study team and customer meetings.
• Take and record minutes, notes and actions at assigned meetings, distribute and follow up accordingly.
• Support the preparation of presentation materials for meetings (internal/external) and project summary data.
• Support the coordination of project team and/or customer meetings including logistics and materials required.
• Identify and escalate discrepancies in project tracking data, timesheet coding, expense data billing etc.
• Establish and manage performance dashboards, analyze event triggers and alerts and determine appropriate follow up for PL or others to act upon.
• Monitor metrics and make required updates in IQVIA systems to ensure accurate and timely reporting is available to senior management.
• Assist in the establishment and maintenance of all project documentation including all files, records and reports according to the scope of work and SOPs.
• Coordinate onboarding of new Key Members and system access.
• Assist in the training and orienting of more junior project support staff.

Qualifications

• Bachelor's Degree in life sciences or other related field required.
• Good knowledge within a specific discipline typically gained through extensive work experience and/or education.
• 3 – 4 years’ experience or equivalent combination of education, training, and experience.
• Knowledge of clinical trials - basic knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Knowledge of clinical systems such as CTMS and experience with Trial Master File (TMF) filing.
• Experience with EAC reporting preferred.
• Strong written and verbal communication skills including good command of English language. Good communication and interpersonal skills.
• Good problem solving skills.
• Results and detail-oriented approach to work, delivery and output. Good planning, time management, and prioritization skills. Attention to detail and accuracy in work.
• Good software and computer skills, including MS Office applications.
• Ability to establish and maintain effective working relationships with co-workers, managers, and clients.
• Ability to work across geographies displaying high awareness and understanding of cultural differences.

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Job Description

Base level role

• Perform comprehensive data management tasks including data review, query generation and query resolution.This may also include, but is not limited to creation of eCRF completion guidelines, entry of test data for eCRF and the Data Review Model, testing of data validation rules, etc.Data Management tasks should be inclusive of Study Start-up, Execution, Database Lock and Close-out.
• Perform ongoing Data Reconciliation of all data streams
• Attend study related meetings/teleconferences
• Perform Study Closeout/Archiving Activities including QC of subject/site Archival CRFs
• Create and provide status/metric reports
• Generate reports on EDC and track cleaning progress
• Manage Freeze / lock of eCRF
• File documentation in the virtual Trial Master File (TMF)
• Receives and enters lab normal ranges

Advance level role

• Provide timely status updates including issues & risks to DM and DMLs as needed
• Act as the Point of contact for Clinical Data Manager, working pro-actively to identify risks and provide mitigations
• May communicate with the vendors to resolve reconciliation issues.
• Provide input to Study set up activities including but not limited to creation of DVRs
• Create and/or provide inputs to Data Management documents (e.g. eCRF completion guidelines, etc.).
• Review and provide inputs to Data Management documents (e.g. IRP, DMP, etc.)
• Assign work to allocated CDAs on a trial.Coordinate work of CDAs assigned to a study working closely with the Global Data Manager to understand priorities and timelines.
• Assist the Data Management Leader in TMF compliance reviews.
• Train and mentor CDA staff
• May serve as an SME and participate in SME forums
• May act as delegate for Data Manager, as needed

Education and Experience Guidelines: 

• Bachelor’s degree in a Health or Science discipline with experience in clinical research.
• Data Management experience and experience working on a clinical trial mandatory.
• Rave experience mandatory
• Experience working in highly diverse teams within clinical research; cross-functional, global, multi- regional.
• Knowledge of current industry standards (e.g., CDISC, SDTM, CDASH, etc.) for Advanced CDA.
• Knowledge of technology platforms and systems to capture and process data
• Project management skills.
• Vendor management skills.
• Proficiency with Microsoft Office tools
• Experience CDA BASE level: 1-3 years of experience.
• Experience CDA ADVANCED level:>3 year of experience

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Job Description

Job Overview

• Responsible for study build & design, edit specifications, system configurations and is accountable for associated study design components. This role will collaborate with various stakeholders- DTL, Programmer, Validation Team, vendors, statisticians, and client representatives. In addition to project deliveries, the role also would be responsible for the project financials from programming shared services perspective.

Essential Functions

• Interprets the study protocol.
• Design and update the eCRF using third party or in house CDMS tools in alignment with industry standards like SDTM, CDASH as applicable.
• Create and update Edit Specification Document.
• Generate specifications for EDC build components (e.g., Rights and Roles, System Settings and Home Page)
• Complete the Study Authorization Form and Trial Capacity Request Form (InForm)
• Attend the Pre-Design Meeting, Online Screen Review Meeting, Unblinded Data review meeting. Attend and present comments at the Internal Design Review Meeting. May lead Online Screen Review Meeting.
• Facilitate the internal Edit Specification Review Meeting and leads the discussions regarding the Edit Specification Document.
• Design the database to collect LLRR data within the InForm database and ensure Rights and Roles document has appropriate access for Entry and Updates.
• Communicate any project risks to the Data Team Lead, including the potential for missing a timeline in the Data Management Project Plan.
• Escalate potential quality issues.
• Ensure the completion and documentation of all project-specific training, as well as staying current with required Standard Operating Procedures.
• Reviews build timelines and provide input as applicable.
• Reviews QIP for own projects, identify out of scope activities if any and inform relevant parties.
• Responsible for multiple study design projects at the same time.
• Might be working on projects across multiple platforms.
• Identify areas for process improvements on an ongoing basis. Actively take part and contribute towards process improvement initiatives as assigned besides providing suggestions for continuous improvement of processes.
• All responsibilities are essential job functions unless noted as nonessential (N).

Qualifications

• Bachelor's Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology Req
• 2-4 years of relevant core Technical designer experience and total exp being 7+ yrs. Req

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Job Description

PURPOSE

• Serve as the EDC System Designer for the build team, and produce accurate and complete specifications documents.

RESPONSIBILITIES

• Development of eCRF to meet the needs of the customer and the clinical trial utilizing protocol and specifications provided at the pre-design meeting. Understand Quintiles EDC processes and the requirements on the design for reporting and study management. 
• Advise and provide justification for design decisions to Principal Programmer and at Design Meeting. 
• Responsible for optimal design reducing the number of edit checks required, ensuring good system performance, and the utilization of global/client specific libraries to ensure consistency and efficiency. 
• This role will eventually (3-6 months after starting) be responsible for providing a draft Edit Check Specification to the DTL. 
• Requires good communication skills and this role will work closely with the Study DTL and Principal Programmer. 
• Requires a technically logical thinker to resolve questions and issues with the Principal Programmer, DTL and VTL. This role will need to have a good knowledge of forms design, data flow, and the impact of design on the system.

EDUCATION

• Bachelor's Degree Health, clinical, biological or mathematical sciences, or related field.
• 3 years direct Data Management experience, including 1 or more years as a CDM project lead. Equivalent combination of education, training and experience.
•  Previous experience and proven competence in managing study delivery through full DM life-cycle (at least 1 medium Phase III). Demonstrated data management skills and thorough knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology). 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 applicable regulatory guidelines.

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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