Clinical Research Manager

Job Description

As a Clinical Research Manager, you will be accountable for the end-to-end performance and project management of assigned protocols in a country. You will ensure compliance with ICH/GCP and country regulations, our company's policies and procedures, quality standards, and adverse event reporting requirements. Reporting to the Clinical Research Director or Therapeutic Area Head, you will play a crucial role in the successful execution of clinical trials.

Key responsibilities include:

• Act as the main point of contact (POC) for assigned protocols and serve as the link between Country Operations and the clinical trial team (CTT).
• Take ownership of project management for the assigned studies, overseeing all aspects of their execution.
• Ensure the performance of assigned protocols in compliance with ICH/GCP and country regulations, as well as our company's policies and procedures.
• Conduct quality control visits as required to ensure adherence to quality standards.
• Lead and inspire local study teams to achieve high performance and meet project goals.
• Develop and execute a local risk management plan for assigned studies, proactively identifying and mitigating potential risks.
• Ensure compliance with key systems and processes related to assigned studies.
• Escalate challenges and issues as appropriate to ensure their timely resolution.
• Identify and share best practices across clinical trials, countries, and clusters to drive continuous improvement.
• Collaborate with functional outsourcing vendors, investigators, and other external partners in the execution of assigned studies.
• Build strong business relationships and represent our company with investigators, acting as a key point of contact for their needs.
• Support local business needs and contribute to local and regional strategy development.

Requirements:

Educational Requirements:

• Bachelor's degree in Science or a comparable field.
• Advanced degree such as a Master's degree, MD, or PhD - Preferred

Experience Requirements:

• Minimum of 5-6 years of experience in Clinical Research.
• Experience as a Clinical Research Associate (CRA) is required, with a preference for experience in Oncology.
• Robust experience in multiple clinical trial management  is essential .

Skills Expectations:

• Strong leadership skills with the ability to effectively manage and motivate teams.
• Excellent negotiation skills to handle tough situations and find solutions.
• Educational/pedagogic, diplomatic, and empathetic skills to build and maintain professional relationships with investigators and stakeholders.

Join our team and make a meaningful impact in the field of Clinical Research.

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:R287141