Senior Clinical Trials Manager (a)

Oviva; Kielce; Hybrid; PLN 60,000 - 80,000; Full time

Job summary

A healthcare organization is seeking a dedicated Clinical Operations Specialist to develop and manage clinical trial protocols. You will coordinate with various teams, ensure compliance, and oversee trial operations from start to finish. The ideal candidate holds a degree in life sciences and possesses strong experience in clinical trial execution. The position offers flexible working options, extensive training, and a competitive salary.

Benefits

Extensive training and development opportunities

Flexible working models

Home office allowance

Competitive salary

Company 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.
• Hands-on experience with clinical trial management systems and related tools.

Responsibilities

• Develop study protocols in collaboration with clinical, statistical, and regulatory teams.
• Take full ownership of trial operations from start-up to publication.
• Oversee budgets, timelines, milestones, and risk management.

Skills

Protocol development

Statistical analysis

Clinical trial execution

Communication skills

Problem-solving mindset

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