[Hiring] Senior Clinical Research Associate @MSD

Role 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.

Qualifications

• 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.

Requirements

• 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

Company Description