Senior Clinical Research Associate (CRA)

Job Description

We are one of the leading pharmaceutical companies in the world dedicated to the discovery development and delivery of innovative medicines that improve health and quality of life for people. With a strong global presence and an unwavering commitment to scientific research our mission is to transform health through innovation and excellence in healthcare.

We value diversity and inclusion fostering a collaborative work environment where all employees can contribute their ideas and talents. We believe that our strength lies in the people who are part of our team and we are constantly looking for passionate and dedicated professionals who want to make a difference.

We are recruiting a Senior Clinical Research Associate (CRA) to join our dynamic team in Portugal. This is a unique opportunity for professionals who wish to contribute to the execution of high-quality clinical studies and have a strong interest in driving innovation in the healthcare field. If you are looking for a stimulating and challenging environment where you can grow and develop your career we are the right place for you.

Come be a part of our mission to improve lives around the world!

In our company the Senior CRA:

• Will be accountable for performance and compliance for assigned protocols and sites in Portugal.
• Ensures compliance of study conduct with ICH/GCP and country regulations our policies and procedures quality standards and adverse event reporting requirements internally and externally.
• Ensures subjects rights safety and well-being are protected.
• Acts as primary site contact and site manager throughout all phases of a clinical research study taking overall responsibility of allocated sites.
• Performs clinical study site management/monitoring activities remote and onsite in compliance with ICH-GCP Sponsor SOPs Local Laws & Regulations Protocol Site Monitoring Plan and associated documents.
• Participates & provides inputs on site selection and validation activities.
• Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME) buddy/mentor and sharing best practices as appropriate/required.

Availability to travel approximately 65%-75% of the working time (2 to 3 days of travel per week).

Experience and Education:

• Bachelors degree in a health-related field.

• Min. 4 years of direct site monitoring experience in a bio/pharma/CRO.

• Fluent in Portuguese and English (spoken and written) with excellent written and oral communication skills.

Skills and Qualifications:

• Good understanding and working knowledge of clinical research phases of clinical trials current GCP/ICH & country clinical research law & guidelines

• Proven Skills in Site Management including management of site performance and patient recruitment

• Experience in conducting clinical trials (validation visits initiation ongoing and closure).

• Ability to understand and analyze data/metrics and act appropriately

• Ability to manage complex scenarios working solution-oriented.

• Good IT skills (MS Office) and knowledge of clinical trial management tools.

• Valid driving license.

Behavioral Competencies:

• Proactive with a positive mindset and problem-solving orientation.

• Responsible and results-focused.

• Detail-oriented and organized.

• Ability to prioritize tasks and manage multiple requests autonomously.

• Capacity to coach junior colleagues

• Good adaptability to a multicultural environment and ability to work in multidisciplinary teams.

Required Skills:

Preferred Skills:

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Current Contingent Workers apply HERE

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Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

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