Job Description

If you:

• 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

Apply today!

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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