[Hiring] Associate Specialist, Clinical Research @MSD

Role Description

Join a multi-award-winning, leading biopharmaceutical company and become part of a growing team of Clinical Research Associates. This is an exciting opportunity to work with innovative technology and smart monitoring tools while enjoying flexibility and a healthy work-life balance.

As a Clinical Research Associate, you will be accountable for the performance and compliance of assigned protocols and sites within your country. Acting as the primary site contact and site manager throughout all phases of a clinical research study, you will take overall responsibility for assigned sites and actively support the development and expansion of the clinical research territory by identifying and building relationships with new sites.

Key responsibilities

• Conduct site visits, including validation, initiation, monitoring, and close-out visits, and prepare clear, accurate, and comprehensive visit and contact reports.
• Ensure that monitoring activities confirm:
  • Data generated at site are complete, accurate, and unbiased.
  • Subjects’ rights, safety, and well-being are protected.
• Perform site management and monitoring activities in compliance with local regulations, ICH-GCP, Sponsor SOPs, the protocol, Site Monitoring Plan, and related documents.
• Coordinate and manage tasks in collaboration with other sponsor functions.
• Communicate effectively with investigators and site staff regarding:
  • Protocol conduct
  • Recruitment
  • Retention
  • Protocol deviations
  • Regulatory documentation
  • Site audits/inspections
  • Overall site performance
• Identify and evaluate site performance, quality, and compliance issues in collaboration with the CRA Manager, Project Manager, Therapeutic Area Head, and Country Director, as needed.
• Manage and maintain clinical trial systems such as CTMS and eTMF.
• Share knowledge and best practices to foster a learning culture and strengthen team efficiency and capability.
• Support and follow the country strategy defined by the Country Director.

Qualifications

• Minimum 1 year of experience in clinical trials.
• Proven experience in site management, including site performance and patient recruitment.
• Strong IT skills with the ability to learn and use new applications quickly.
• Ability to understand and analyze data and metrics.
• Strong problem-solving skills and a solution-oriented mindset.
• Fluent in English and the local language, with excellent communication and presentation skills.
• Good understanding of clinical research, local regulations, and ICH-GCP.
• Master’s degree (M.A. or M.Sc.) with a strong medical or bioscience background.
• Willingness to travel domestically and internationally approximately 50% of the time (around 2–3 days per week).
• Valid driving license.

Requirements

• Adverse Event Report
• Biomedical Sciences
• Business Activity Monitoring
• Clinical Evaluation Reports
• Clinical Research
• Clinical Research Methods
• Clinical Study Management
• Clinical Trial Management
• Clinical Trial Management Systems (CTMS)
• Clinical Trial Planning
• Clinical Trial Process
• Clinical Trials Monitoring
• Data Analysis
• Good Clinical Data Management Practice (GCDMP)
• Good Clinical Practice (GCP)
• Investigations Training
• Key Stakeholder Relationships
• Medical Biology
• On Site Monitoring
• Patient Recruitment
• Protocol Adherence
• Regulatory Compliance
• Root Cause Analysis (RCA)
• Site Management
• Site Operations Management

Company Description

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.