For our Client, an international innovative pharmaceutical company, we are actively looking for Candidate experienced within clinical research field on an international level. 

The Global Study Manager (GSM)
(Warsaw or Cracow)

Working closely with the Global Study Leader the GSM is responsible for supporting the operational delivery of all phases clinical studies ensuring quality and compliance.

The exact accountabilities will differ depending on the exact nature of the clinical programme, so a high degree of flexibility is required.

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.

Qualifications:

• Have a University degree / Bachelor's degree in a related subject area, preferably in medical or biological science, or one related to Clinical Research;
• Possess a minimum of 2 years operational clinical trial experience in a global Study Management role within Clinical Development, as well as an excellent knowledge of ICH-GCP;
• Have experience of working with and delivering through strategic partners and 3rd party vendors;
• Be fluent in written and spoken English;
• Ability to coordinate and prioritise multiple tasks and deliverables;
• Demonstrated problem-solving skills and proactive approach;
• High degree of flexibility;
• Good communication, negotiation, collaboration and interpersonal skills;
• Some travel may be required.

Offer:

• Permanent contract;
• Office based role (Mon-Friday);
• Opportunity for development;
• Competitive salary and benefits package;
• Medical care & Health Insurance;
• Life Insurance;
• Performance annual bonus and merit increase;
• Benefit System.

PLEASE ADD TO YOUR RESUME:

I hereby agree to the processing of my personal data for recruitment by Timshel Sp. z o.o. for the position of Global Study Manager. I hereby agree to the processing of my personal data for recruitment by Timshel Sp. z o.o., for the purpose of other vacancies compliant with my qualifications, no longer than three years from the day of application.

The administrator of personal data is Timshel Sp. z o.o. with headquarters at ul. Dolna 30/3, 00-774 Warsaw. Personal data is processed for the recruitment carried out by Timshel on behalf of and for the benefit of its client for the position indicated in the announcement. For the detailed information on terms and conditions of processing personal data, see our Privacy Policy.

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