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  • Posted: Oct 17, 2024
    Deadline: Not specified
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    IQVIA, formerly Quintiles and IMS Health, Inc.,is an American multinational company serving the combined industries of health information technology and clinical research. It is a provider of biopharmaceutical development and commercial outsourcing services, focused primarily on Phase I-IV clinical trials and associated laboratory and analytical services,...
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    Associate CRA

    Job Overview
    Engage in structured training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.

    Essential Functions

    • Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
    • Gain experience in study procedures by working with experienced clinical staff.
    • Under close supervision, perform site monitoring visits (selection, initiation, monitoring and close out visits) in accordance with contracted scope of work and good clinical practices.
    • Under close supervision, administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
    • Under close supervision, 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.
    • Under close supervision, 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 Good Clinical Practice (GCP) /  International Conference on Harmonization (ICH) and local regulatory requirements.
    • Under close supervision may support start-up phase.
    • Under close supervision, 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, learn key facets for successful development of project subject recruitment plan on a per site basis. Suggest ideas for improving site recruitment plan in line with project needs to enhance predictability. Assist in tracking subject site recruitment progress.

    Qualifications

    • Bachelor's Degree Degree in scientific discipline or health care preferred. Req
    • Equivalent combination of education, training and experience may be accepted in lieu of degree.
    • Prior clinical experience preferred.
    • Some organizations may require 2 years of clinical experience.
    • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
    • Written and verbal communication skills including good command of English language.
    • Organizational and problem-solving skills.
    • Effective time and financial management skills.
    • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
    • Advanced knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
    • Knowledge of applicable protocol requirements as provided in company training.

    go to method of application »

    Engagement Manager - French Speaking

    A lead 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 Senior management; 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.
    • Thought Leadership: Manage research, analysis and delivery of thought leadership reports (global and domestic) with guidance from senior team professionals.

    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.

    Language competency

    • English: minimum C1 level
    • French: C1 level or more would be a considerable advantage
    • Portuguese: B2 level or more would be a considerable advantage
    • Master’s in Public Health / Health Administration / Social Sciences / Business Administration/ Economics/ Public Policy / international development,
    • Graduation: Any (MBBS/BHMS is desirable)
    • Should have relevant experience of 12+ years working for a governmental, intergovernmental and/or non-governmental organization in health sector
    • Should have a flair for business development through proposal / grant writing and proactive outreach to the potential funders. Should be comfortable in making an elevator pitch to external stakeholders. Should be able to own and chase revenue and sales target numbers.
    • Prior consulting / advisory experience in public health sector in Africa is a desirable
    • Excellent understanding of health sector, public health structure, multi-laterals and health programs in Africa. Experience in one or more areas such as Maternal and Child Health, TB, Malaria, Non-Communicable Diseases, Healthcare Research, etc.
    • Prior experience of proposal development and managing projects for government clients and donor agencies
    • Excellent project management skills with effective communication and team-management skills
    • Government and development partner Stakeholder management, financial planning and management, team coordination and good writing skills.
    • Project management and Problem-solving capabilities
    • Report writing and PowerPoint development skills
    • Willingness to travel and adaptability to change
    • Stay informed about research and trends in our program areas and in research and evaluation to inform our strategy accordingly.
    • Network with other institutions running similar programs to find areas of collaboration and knowledge sharing
    • Experience with Africa CDC, Africa Union, UN agencies, the Global Fund, etc would be an asset

    Method of Application

    Use the link(s) below to apply on company website.

     

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