Gateway to clinical research for language speakers – begin your career at Late Phase Department

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    ID ponuky v systéme profesia.sk

    2317342

    Kód jazyka, v ktorom je písana ponuka

    en

    Dátum zadania pracovnej ponuky

    2015-11-05 11:44:08

    Pozícia zo zoznamu preddefinovaných pozícií

    • Administratívny pracovník, referent
    • Clinical Data Manager
    • Monitor klinických štúdií

    Región, v ktorom je pracovná ponuka platná

    Kategória, v ktorej je pracovná ponuka zaradená

    • Administratíva
    • Farmaceutický priemysel

    Popis práce

    Quintiles (NYSE: Q) is the world’s largest provider of biopharmaceutical development and commercial outsourcing services with a network of more than 29,000 employees conducting business in approximately 100 countries. We helped develop or commercialize all of 2013’s top-100 best-selling drugs on the market.

    Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes. To learn more about Quintiles, please visit www.quintiles.com

    PURPOSE
    Engage in company training program to gain knowledge and skills required to independently conduct clinical remote monitoring visits and other clinical research activities in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements. Gain an understanding of all aspects of Real World Late Phase Research (RWLPR) site management and monitoring by striving to understand the work based on a combination of structured training programs, self-directed use of training materials and experience from study assignments.
    RESPONSIBILITIES

    • Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
    • Gain experience with standard Quintiles tools, metrics and reports.
    • Develop an understanding of how sites are staffed and operate in order to build strong relationships with personnel at assigned sites
    • Gain experience in study procedures by working with experienced Site Management staff. May also work collaboratively with other functional groups such as Project Management, Regulatory Start-Up (RSU) and Epidemiology.
    • Under close supervision, may perform site selection, start-up/regulatory, initiation, monitoring and close out visits in accordance with contracted scope of work, good clinical practices applicable regulations, SOPs and work instructions.
    • Under close supervision, administer protocol and related study training to assigned sites and establish 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 to Clinical Project Manager (CPM), Site Management Lead (SML) and/or line manager.
    • Under close supervision, manage the progress of assigned studies by documenting regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.
    • 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, essential document collection and filing and other required study documentation.

    Požiadavky na uchádzača

    REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

    • Awareness of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
    • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
    • Strong written and verbal communication skills in applicable languages, and business level command of English
    • Basic organizational, interpersonal and problem-solving skills
    • Strong attention to detail
    • Working time management skills
    • Ability to establish and maintain effective working relationships with coworkers, managers and clients and site personnel at assigned sites

    MINIMUM REQUIRED EDUCATION AND EXPERIENCE

    • Degree or currently enrolled in bachelor’s degree program preferably in life science; or equivalent combination of education, training and experience
    PHYSICAL REQUIREMENTS

    • Extensive use of telephone and face to face communication requiring accurate perception of speech
    • Extensive use of keyboard requiring repetitive motion of fingers
    • Regular sitting for extended periods of time
    • May require occasional travel

    Krátka charakteristika klienta spoločnosti

    Quintiles is the world’s leading provider of biopharmaceutical services. With a network of more than 29,000 professionals working in more than 100 countries, we have helped develop or commercialize all of the top 100 best selling drugs on the market. With extensive therapeutic, scientific and analytics expertise, we help biopharmaceutical and health sciences customers navigate the increasingly complex landscape with more predictability to enable better outcomes.

    Pozícia vhodná pre absolventa

    Áno

    Možný dátum nástupu

    asap

    Typ pracovného pomeru

    • full-time

    Dosiahnuté vzdelanie

    • University education (Master’s degree)
    • University education (Bachelor’s degree)
    • Postgraduate (Doctorate)

    Názov spoločnosti

    Quintiles Slovakia Services, s.r.o.

    Charakteristika spoločnosti

    Quintiles is the world’s leading provider of biopharmaceutical services. With a network of more than 29,000 professionals working in more than 100 countries, we have helped develop or commercialize all of the top 100 best selling drugs on the market. With extensive therapeutic, scientific and analytics expertise, we help biopharmaceutical and health sciences customers navigate the increasingly complex landscape with more predictability to enable better outcomes.

    Hlavná oblasť pôsobenia spoločnosti, pre ktorú je pozícia obsadzovaná

    Pharmacy

    Znalosti

    • Language skills
    • Danish – expert (interpreting)
    • Administrative and economic skills
    • Business correspondence – expert
    • Computer skills – user
    • Microsoft Excel – expert
    Poslať spoločnosti životopis

    Zdroj: www.profesia.sk