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MSD Senior Clinical Research Associate Poland, Masovian Voivodeship 239543421
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 problemsin 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 yearsof 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.
Current Contingent Workers apply
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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