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Pracodawca zakończył zbieranie zgłoszeń na tę ofertę

Aktualne oferty pracodawcy

Global Study Manager

Devire

  • Kraków

    Kraków, Lesser Poland
  • offer expired over a month ago
  • contract of employment
  • full-time
  • specialist (Mid / Regular)

Recruitment for

A global, science-led biopharmaceutical organization that creates innovative medicines for millions of patients worldwide.

Warsaw/Cracow

Your responsibilities

  • Contribute to the development of study documents as appropriate as well as any updates/amendments, ensuring template and version compliance;

  • Lead the preparation of country specific agreements, confidentiality agreements, clinical trial applications and other applicable country documents;

  • Manage the set-up of third-party vendors, assessing initial statement of work and budget, as well as the change order process;

  • Provide input to data management documents (e.g. Case Report Form, Data Validation Specifications), and interface with data management representatives and sites to facilitate the delivery of study data;

  • Initiate contract/budget requests and track ongoing status; facilitate generation of purchase orders, review vendor invoices and assist in tracking spend against approved budget;

  • Ensure the supply of Investigational product and study materials by liaising with Drug Supply or external service providers as appropriate;

  • Interface with third party vendors, global / local internal staff and investigator sites to support effective delivery of a study and its regulatory documents from development of the protocol through to the Clinical Study Report;

  • Assist in the clinical trial insurance process; track approvals, revisions and renewals of certificates;

  • Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study to the necessary quality, timelines or budget;

  • Support risk management and quality efforts to ensure study compliance;

  • Support set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring continual inspection readiness;

  • Prepare presentation material for meetings, newsletters and websites;

  • Support the study team in the implementation of audits and regulatory inspections;

  • Contribute to review of new/amended/unique SOPs and guidance documents.

Employer requirements

  • Relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years - knowledge of clinical development / drug development process in various phases of development and therapy areas;

  • Excellent communication and relationship building skills, including external service provider management skills - excellent stakeholder management and project management skills;

  • Excellent knowledge of international guidelines ICH/GCP;

  • University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research;

  • Demonstrated ability to collaborate as well as work independently;

  • Demonstrated leadership skills;

  • Computer proficiency, advanced computer skills in day-to-day tasks;

  • Excellent verbal and written communication in English.

What employer offers

  • Permanent contract;

  • Office based role 3 days per week;

  • Opportunity for development;

  • Competitive salary and benefits package;

  • Medical care & Health Insurance;

  • Life Insurance;

  • Performance annual bonus and merit increase;

  • Benefit System

Devire

Devire is an international company specializing in recruitment, outsourcing and employer branding services. For more than 30 years, we have represented leading employers on the European market, by carrying out comprehensive recruitment projects, implementing the latest solutions in the area of IT services and by supporting in building the image of the employer of choice. Our offices are located in Warsaw, Wroclaw, Poznan, Katowice as well as Munich, Frankfurt, Prague and Hradec Kralove.

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