Job Description

This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCPand country regulations, policies and procedures, quality
standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, the person is responsible for execution and oversight of clinical trial country submissions and
approvals.

Qualification/Experience & Skills:

• 2 years of experience in Clinical Research
• Bachelor's degree in Health Care
• Basic knowledge of local regulatory environment and submission and approval processes, and understanding of how these impact study start-up.
• Positive & growth mindset, capable of working independently and being self-driven
• Ability to propose solutions to local study teams.
• ICH/GCP knowledge appropriate to role. Hands on knowledge of Good Documentation Practices
• Able to work with other experienced clinical research professionals to learn and develop skills to manage protocols independently. Works with high quality and compliance mindset.
• Effective and efficient time management, organizational and interpersonal skills, conflict management and problem-solving skills.
• High sense of accountability and urgency in order to properly prioritize deliverables
• Strong communication and negotiation skills in local language and English.
• Ability to focus on multiple deliverables and protocols simultaneously is essential.
• Good IT skills and ability to adapt to new IT applications
• Excellent verbal and written skills, in local language and English
• Strong coordination and organizational skills

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):

Requisition ID:R259832