Senior Clinical Trials Manager (a)

Oviva; Województwo kujawsko-pomorskie; Remote; PLN 120,000 - 180,000; Full time

Job summary

A clinical research organization in Poland is seeking a Clinical Trial Manager to lead trial operations. You will oversee the development of protocols, ensure compliance with regulations, and manage external partners. The ideal candidate holds a degree in life sciences and has proven experience in clinical trial execution. This role offers flexible working arrangements, a competitive salary, and meaningful impact in healthcare.

Benefits

Flexible working models

Personal learning budget

Home office allowance

Company pension scheme

Qualifications

• Proven experience in protocol development and clinical trial execution.
• In-depth knowledge of ICH-GCP, ISO14155, EU MDR, and local regulations in DE, CH, and UK.
• Fluent in English; German is a plus.

Responsibilities

• Develop study protocols in collaboration with clinical and regulatory teams.
• Oversee trial operations from start-up to publication.
• Ensure data quality and regulatory compliance.

Skills

Protocol development

Collaboration

Problem-solving

Communication skills

Data quality assurance

Education

Degree in life sciences, medicine, or related field

Tools

CTMS

EDC

eTMF

IWRS/eCOA

Job description

Responsibilities

• Develop study protocols in collaboration with clinical, statistical, and regulatory teams
• Take full ownership of trial operations – from start-up to publication
• Coordinate external partners including CROs, trial sites, and technical vendors across Germany, Switzerland, and the UK
• Oversee budgets, timelines, milestones, and risk management
• Share your expertise to foster a collaborative, learning-oriented team culture
• Ensure data quality, regulatory compliance, and audit readiness at all times

Qualifications

• A degree in life sciences, medicine, or a related field
• Proven experience in protocol development, statistics, literature review, and clinical trial execution
• In-depth knowledge of ICH-GCP, ISO14155, EU MDR, and local regulatory environments in DE, CH, and UK
• Hands-on experience with CTMS, EDC, eTMF, IWRS/eCOA, and user acceptance testing
• Strong communication skills, a problem-solving mindset, and collaborative spirit
• Fluent in English (spoken and written) - German is a plus!

What we offer

• A meaningful role where your work drives real impact in healthcare
• A dynamic and purpose-driven environment in a fast-growing organisation
• Extensive training and development opportunities, including a personal learning budget
• Flexible working models and remote-first options to support your work-life balance
• A home office allowance to help you create your ideal workspace
• Competitive salary and company pension scheme