Senior Clinical Research Associate

MSD; Województwo mazowieckie; On-site; PLN 120,000 - 180,000; Full time

Job summary

MSD is seeking a Clinical Research Associate to join a multi-award-winning biopharmaceutical company. You will be the primary site contact and manager for assigned sites across the country, ensuring performance and compliance and developing new sites.

Responsibilities include conducting site visits, monitoring data quality, ensuring subject safety, and coordinating with sponsor roles. You will use CTMS and eTMF systems and travel domestically and internationally about 50% of time, with driving

Qualifications

• Min 3 years of direct site management (monitoring) experience in bio/pharma/CRO.
• Proven skills in site management, including performance and patient recruitment.
• Good IT skills, ability to learn and operate new IT applications.
• Ability to understand and analyse data/metrics.
• Capable of managing complex issues in a solution-oriented manner.
• Fluent in English and local language with excellent communication and presentation skills.
• Good understanding of clinical research, local regulations, ICH-GCP.
• MA/MSc degree with strong emphasis in medical/bioscience background.
• Ability to travel domestically and internationally ~50% of time.
• Valid driving license.

Responsibilities

• Conduct site visits (validation, initiation, monitoring, close-out) and record reports.
• Ensure monitoring activities yield complete, accurate data and protect subjects' rights and safety.
• Perform site management/monitoring in compliance with regulations and SOPs.
• Coordinate and manage tasks with sponsor roles.
• Communicate with Investigators and site staff on protocol, recruitment, documentation and audits.
• Identify and assess site performance and compliance issues with CRA Manager and Country Director as needed.
• Manage and maintain CTMS, eTMF and related systems.
• Share knowledge and best practices to boost team efficiency.

Skills

Site management

Data analysis

Communication

Travel readiness

Education

MA/MSc in medical or bioscience

Tools

CTMS

eTMF

Job description

Job Description If you want to: Join a multi-award-winning leading biopharmaceutical company Be part of growing team of Clinical Research Associates Use new technology and smart monitoring tools Have flexibility of work and good work-life balance

On this position you will be accountable for performance and compliance for assigned protocols and sites in a country. You will act as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites and actively develop and expand the territory for clinical research, finding and developing new sites.

Your key responsibilities:

• Conduct site visits (validation visits, initiation visits, monitoring visits, close-out visits) and record clear, comprehensive and accurate visit & non-visit contact reports.
• Ensure by monitoring activities that:
  • Data generated at site are complete, accurate and unbiased.
  • Subjects' right, safety and well-being are protected.
• Perform clinical study site management/monitoring activities in compliance with local regulations, ICH-GCP, Sponsor SOPs, protocol, Site Monitoring Plan and associated documents.
• Coordinate and manage various tasks in collaboration with other sponsor roles.
• Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identify and assess site performance, quality or compliance problems in collaboration with CRA Manager, Project Manager, Therapeutical Area Head and Country Director as needed.
• Manage and maintain clinical trial systems such as CTMS, eTMF, etc.
• Share the knowledge and best practices, nurture a learning culture to boost efficiency and competence of our team.
• Follow the country strategy defined by Country Director.

You should apply if you have:

• Min. 3 years of direct site management (monitoring) experience in a bio/pharma/CRO.
• Proven skills in site management, including management of site performance and patient recruitment.
• Good IT skills, ability to learn and operate new IT applications.
• Ability to understand and analyse data/metrics.
• Capable of managing complex issues, works in a solution-oriented manner.
• Fluent in English (verbal and written) and local language, excellent communication and presentation skills.
• Good understanding and working knowledge of clinical research, local regulations, ICH-GCP.
• M.A/ M.Sc degree with strong emphasis in medical/bioscience background.
• Ability to travel domestically and internationally approximately 50% of working time.
• Expected travelling ~2-3 days/week.
• Valid driving license.

Additional location(s)

Compensation Information: Required Skills: Clinical Data Management, Clinical Development, Clinical Reporting, Clinical Research Operations, Clinical Research Organizations (CRO) Management, Clinical Study Management, Clinical Trial Management, Clinical Trials Monitoring, Drug Development, Good Clinical Data Management Practice (GCDMP), On Site Management, Patient Recruitment, Protocol Compliance, Site Management

Preferred Skills:

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Remote Shift: Valid Driving License: Hazardous Material(s):

Job Posting End Date: 10/22/2026.

The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.