Informacje o stanowisku

We are currently recruiting for the position of Associate Clinical Trial Manager in Poland for a global leader in the diagnostic and medical industry. The person in this role will be part of the Clinical Trials Team, responsible for the planning, execution, management, and closure of projects related to the companys clinical trial plans. A key part of the role will also involve managing, executing, and reporting on clinical trial operations, as well as providing support to members of the multidisciplinary project team, both internal and requiring collaboration in the execution of assigned studies.

Apply and tell us about yourself!

What we expect

• Bachelors degree in Life Sciences or another relevant field.
• A minimum of three years of experience in clinical research, including at least one year of clinical research experience with a sponsor/CRO. Additional experience as a study coordinator or clinical research associate is preferred.
• Clinical monitoring experience, including data review, query resolution, protocol deviation tracking/trending, clinical site payment setup/review, and clinical sample management.
• Experience in writing, reviewing, and editing protocols.
• Knowledge of Good Clinical Practice (GCP) and all applicable European Union regulations governing clinical research, as well as knowledge of the FDA submission process, including IDE, PMA, and 510(k).
• Experience in sample management system setup.
• Excellent organizational and communication skills, including experience in dealing with decision-makers such as physicians, IRB members, and FDA staff.
• Fluency in the English language (C1 or above according to the CEFR framework).
• Demonstrated ability to perform the essential duties of the position with or without accommodation.

Employment agency entry number 47

this job offer is intended for people over 18 years of age

What we offer

• Employment under a contract.
• Private medical care.
• Multi-Sport Card.
• Personal insurance plan.
• Annual bonus.
• Hybrid work system: 3 days from the office and 2 days of remote work per week.
• Time off to volunteer.
• Employee recognition platform.
• Real opportunities to grow your skills in a global setting.
• Chance to contribute to impactful clinical studies that shape healthcare solutions.

Your tasks

• Act as the client advocate throughout the project lifecycle.
• Understand and support global project objectives, including site recruitment, patient recruitment, marketing, and PR, as applicable.
• Implement approved clinical trial protocols. Develop study-specific consent forms and other trial-related materials (e.g., Study Monitoring Plan, Patient Guide, Project Plan).
• Coordinating with relevant cross-functional teams to define the goals and scope of clinical study projects; managing the execution of the project, including monitoring its scope and timeline.
• Initiate and train sites on the study protocol; ensure sites adhere to clinical research regulations.
• Manage resources and timelines related to study preparation activities, including CRO/investigator agreements, central IRBs, and contractual agreements.
• Provide support in the management and oversight of CROs and other clinical study vendors, as required.
• Plan and manage materials necessary for the effective execution of clinical projects, including the distribution of documents, forms, materials, equipment, and investigational devices.
• Ensure the maintenance of document standardization through the use of model documents, templates, and appropriate peer review.
• Ensure the proper development of all documents by CROs, including consent forms, case report forms, and other project-specific documentation.

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