Clinical Research Manager

hace 2 semanas

Madrid, 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.

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Not Applicable

**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R287141

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