Senior Clinical Trials Manager (a)

Oviva; Bydgoszcz; Hybrid; PLN 120,000 - 180,000; Full time

Job summary

A healthcare innovation company based in Bydgoszcz is seeking a skilled clinical trial manager to develop protocols and oversee trial operations. This role involves coordinating with various partners and ensuring data quality and compliance. The ideal candidate will have a strong background in life sciences, excellent communication skills, and fluency in English. The position offers flexible working models and competitive salary.

Benefits

Extensive training and development opportunities

Home office allowance

Flexible working models

Competitive salary and pension scheme

Qualifications

• 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.

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.

Skills

Protocol development

Clinical trial execution

Statistical analysis

Strong communication skills

Problem-solving mindset

Collaborative spirit

Fluency in English

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

Our requirements

• 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