Clinical Research Manager

Encontrado en: beBee S ES - hace 1 mes

San Blas, España MSD A tiempo completo

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: Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

R287141

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