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  • Posted: Feb 24, 2022
    Deadline: Not specified
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  • Sharing a Vision to Drive Healthcare Forward Healthcare is an industry designed to help humans. As a global community, we continuously invest and commit to advancing human health. To deliver value and real outcomes. To rise to the challenge to find the next breakthrough by making the most of increasingly limited resources. We are inspired by the potential ...
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    Business Operation Manager

    Job Overview
    Individual contributor with advanced knowledge acquired from several years of experience in the professional discipline. Works independently under limited supervision.

    Essential Functions

    • Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/or may act as a Project Manager for a stand-alone project, with guidance from senior staff as appropriate;
    • Competently writes regulatory and/or technical documents with minimal review by senior staff;
    • Establishes relationships with many customers; may meet face to face without rest of team to discuss regulatory issues and present lessons learned. Adopts a proactive and flexible approach to resolve any issues;
    • Undertakes detailed review and management of budgets related to projects, including out of scope activities. Ensures revenue is recognised and challenges when appropriate, may seek guidance from senior staff as appropriate;
    • May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development;
    • May present to clients at bid defense meetings by phone or in person, for a range of regulatory deliverables, at discretion of senior staff;
    • May write new regulatory standard operating procedures, and/or propose revisions and/or act as reviewer for regulatory standard operating procedures, as assigned and appropriate.
    • May be involved in a Regulatory and/or IQVIA Initiative;
    • Performs other tasks or assignments, as delegated by Regulatory management;
    • May manage meetings with Regulatory Agencies;
    • May be assigned as Reviewer and/or Approver for Regulatory standard operating porcedures or cross-functional standard operating porcedures owned by other operations;
    • May support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative;
    • Performs other duties, as business needs require;

    Qualifications

    • Bachelor's Degree Degree in Lifescience or related discipline Req Or
    • Master's Degree Degree in Lifescience or related discipline
    • At least 8 years relevant experience
    • Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate;
    • Possesses a specific regulatory or technical expertise. Sufficient knowledge of managing regulatory projects, project deliverables on a time bound manner;
    • Expert in planning and delivering work on time keeping quality parameter in mind;
    • Knowledge of regulatory procedures in appropriate region – particularly marketing authorization transfers and relevant cross-functional dependencies;
    • Good working knowledge of regional regulatory intelligence;
    • Ability to work closely with client regional heads to determine the MAT, Regulatory Publishing & submission strategy and execute marketing authorization transfer plan, if applicable;
    • Good understanding of pharmacovigilance activities relevant to transfer of marketing authorization;
    • Ability to establish and maintain effective working relationships with coworkers, managers and clients;
    • Strong software and computer skills, including Microsoft Office, publishing applications and tools, as applicable;
    • Ability to work on several projects, with direction from senior staff as appropriate;
    • Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements;
    • Ability to make decisions on discrete tasks under senior supervision;
    • Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education;
    • Experience of involvement in regulatory strategy and determination of documentation requirements, timelines, budgets for MATs, Publishing projects;
    • Project leadership experience;
    • Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area;
    • Problems faced are general and may require understanding of broader set of issues, but typically are not complex;
    • Ability to adapt quickly to a rapidly changing environment;
    • Applicable certifications and licenses as required by country, state, and/or other regulatory bodies

    Locations: Belville, South Africa, Bryanston, South Africa, Centurion, South Africa, Bloemfontein, Benin

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    Site & Resource Manager (Cape Town and Gauteng)

    Job Description
    IQVIA South Africa is looking for a Site and Resource Manager who can assist in managing Clinical staff. Position based in Cape Town or Gauteng .Manage a team of clinical staff working in support of clinical studies to ensure projects are appropriately resourced and employees are trained and meeting project objectives.

    Essential Functions

    • Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work, assessing performance and guiding professional development, rewarding and disciplining employees, and addressing employee relations issues and resolving problems.
    • Participate in the selection for hiring new employees by conducting candidate review and participating in the interviewing process. Ensure that new employees are properly onboarded and trained.
    • Ensure that staff has the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and training experiences, as applicable.
    • Participate in the allocation of resources to clinical research projects by assigning staff to clinical studies based on their experience and training.
    • Manage the quality of assigned staff's clinical work through regular review and evaluation of work product.
    • Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
    • Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management.
    • May collaborate with other clinical teams and other functional leadership to manage project related challenges and to achieve exemplary customer service.
    • Participates in corporate or organizational departmental quality or process improvement initiatives.

    Qualifications

    • Bachelor's Degree Degree in scientific discipline or health care preferred. Req
    • Prior clinical trial experience including experience in a management/leadership capacity or equivalent combination of education, training and experience.
    • In-depth knowledge of applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
    • Good leadership skills.
    • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
    • Written and verbal communication skills including good command of English.
    • Excellent organizational and problem solving skills.
    • Effective time management skills and ability to manage competing priorities.
    • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

    Location:Belville, South Africa, Centurion, South Africa

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    Regulatory & Start-Up Coordinator

    Job Overview

    Under general supervision, perform tasks at a country level associated with site activation 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.

    Essential Functions

    • Under general supervision, perform site activation activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the  Site Activation Manager (SAM), Project Management team, and other departments as necessary.
    • Review documents for completeness, consistency and accuracy, under guidance of senior staff.
    • Prepare site regulatory documents, reviewing for completeness and accuracy.
    • Inform team members of completion of regulatory and contractual documents for individual sites.
    • Distribute completed documents to sites and internal project team members.
    • Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.
    • 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.

    Qualifications

    • Grade 12 with 2 - 3 years’ experience in an administrative environment or equivalent combination of education, training and experience.
    • Good interpersonal communication and organizational skills.
    • Good word processing skills and knowledge of MS Office applications.
    • Good attention to detail.
    • General awareness clinical trial environment and drug development process.
    • Ability to work on multiple projects.
    • Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.

    Locations: Belville, South Africa, Bloemfontein, Benin, Centurion, South Africa

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    Project Manager

    Job Description

    IQVIA is looking for a Project Manager for Public Health. The manager is expected to contribute to the firm's growth and development in a variety of ways, including:

    • Project Delivery: Understand client requirements, project scope and deliverables; Lead project delivery and client meetings under overall guidance of EM/ cluster lead; follow Assess-Design-Develop-Deliver-Monitor process in various work modules of the project; project team management and coordination with internal and external stakeholders etc. Also, would manage vendor, Design & Delivery and Data Processing, maintain field schedules, monitoring and communicating deadlines to team; checking programmed questionnaires; monitoring and maintaining progress of fieldwork; specifying deliverable requirements; final review of member deliverables. Contribute to team process improvements 
    • Operational excellence: Ensuring project profitability, timely delivery of projects, invoicing and collection, quality & risk management, positive feedbacks from the client, etc.
    • Business Development: Identification and development of work opportunities, client requirement analysis, development of EoI/proposals, client presentations, etc.
    • Practice Development: Support and lead learning and development initiatives for the team/project/organization.
    • As lead, the primary role would be to manage & lead project work streams/modules and client interactions with support from Sr. consultants/ Consultants in team. Additionally, you would be coaching team on technical and management areas.

    Location: Centurion, South Africa

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    Statistical Programming Scientist: Real World Evidence – homebased or hybrid working

    Job Overview:

    As a Statistical Programming Scientist/Principal, you will provide advanced technical expertise to develop process methodology for the department to meet internal and external clients’ needs, across complex projects and studies.

    This involves planning and coordinating the development of integrated programming solutions serving the full spectrum of statistical programming needs.

    You will provide internal consulting services, including specifications and user needs analysis for complex project or client requirements.

    Requirements: 

    • 7+ years’ Statistical Programming experience within the Life-Science Industry 
    • Advanced knowledge of statistics, programming and/or clinical drug development process
    • Advanced knowledge of computing applications such as Base SAS, SAS Graph and SAS Macro language
    • Advanced knowledge of relevant Data Standards (such as CDISC/ADaM/SDTM)
    • Bachelors or Masters’ in Computer Science, Mathematics or equivalent
    • Already possess the right to work in EMEA

    Location: Centurion, South Africa

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    Software Development Analyst

    PURPOSE   
    Provide advanced technical expertise as part of a team to develop and maintain clinical systems to meet internal and external client needs. Plan and coordinate database design and development for local, regional, or transnational use. Provide leadership to the Clinical Data Programming department in the area of technical expertise.

    RESPONSIBILITIES

    • Serve as Lead Programmer on the corporate team.
    • Plan and coordinate database design, development, implementation, maintenance, and user support of clinical systems.
    • Provide expert technical expertise in conjunction with internal and external clients.
    • Program, test, and document databases in accordance with programming standards and validation procedures.
    • Program database manipulation and transfer of data for internal and external clients.
    • Mentor other team members and lead Programmers in training and developing technical and/or database expertise.
    • Independently bring project solutions to the CDP teams and the Clinical Data Programming department.
    • May assist IT in evaluating and implementing new technologies.
    • May assist IT in testing and evaluating new upgrades to technologies.
    • May assist in developing, revising, and maintaining core operating procedures and working instructions.
    • Meet objectives as assigned, and interact with the project team to organize timelines, responsibilities and deliverables.
    • Develop and maintain good communications and working relationships with teams and external clients.

    REQUIRED KNOWLEDGE, SKILLS AND ABILITIES  

    • Clinical Data Programming: Excellent knowledge of Oracle and/or SAS
    • Laboratory Data Programming: Expert knowledge of VGL and/or BizTalk and/or C# and/or .NET
    • Solid understanding of clinical drug development process
    • Excellent organizational, communication, and technical database skills
    • Ability to establish and maintain effective working relationships with co-workers, managers and clients

    MINIMUM REQUIRED EDUCATION AND EXPERIENCE      

    • Bachelor’s degree, or educational equivalence, in computer/life science or related field with 3 years of relevant work experience; or equivalent combination of education, training and experience 

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    Senior Data Team Lead, home-based in South Africa

    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

    Locations: Bloemfontein, Benin, Centurion, South Africa, Belville, South Africa

    Method of Application

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