Clinical Operations Manager

Caraway Therapeutics, Inc.; Paço de Arcos; On-site; EUR 70,000 - 100,000; Full time

Job summary

Caraway Therapeutics, Inc. seeks a Clinical Operations Manager to oversee country-level study start-up, regulatory submissions, and operational delivery of trials in Portugal.

You will coordinate with Finance, Legal, Regulatory, and vendors to ensure milestones are met while maintaining compliance with ICH-GCP and EU CTR regulations. The role requires strong budget management, contract negotiations, and leadership skills, with fluency in Portuguese and English.

Qualifications

• Bachelor's degree in Life Sciences, Business Administration, Finance, Healthcare or related.
• Minimum 5 years of experience in clinical research or related operations.
• Strong knowledge of ICH-GCP, EU CTR and IVDR regulatory requirements.
• Experience with budget management and CTRAs/CTAs.
• Fluent in Portuguese and English (written and spoken).

Responsibilities

• Lead country-level start-up activities: submissions, approvals, ethics interactions, regulatory authority communications.
• Manage local study operations: consent, supplies, import/export, archiving, insurance, and compliance docs.
• Own country/site budgets, financial compliance, payments, and CTRAs.
• Collaborate with Finance, Legal, Regulatory, Pharmacovigilance and vendors to hit milestones.
• Drive process improvements and contribute to local SOPs; act as SME for operations.
• Mentor and onboard staff, contribute to strategic local initiatives.

Skills

Stakeholder management

Negotiation

Budget management

Cross-functional collaboration

Problem solving

Regulatory knowledge

Communication

Portuguese & English fluency

Travel flexibility

Education

Bachelor's degree in Life Sciences / related field

Tools

Clinical trial systems

AI-enabled clinical tools

Job description

Job Description

Reporting to the Clinical Research Country Lead, an exciting opportunity has arisen for a Clinical Operations Manager . This position is responsible for ensuring the performance, compliance, and execution of assigned clinical trial protocols within the country, in accordance with ICH‑GCP guidelines, local regulatory requirements, company policies, quality standards, and safety reporting obligations.

The role plays a critical part in supporting study start-up, regulatory submissions, financial management, and operational delivery of clinical trials. Working closely with internal stakeholders, investigators, vendors, and regulatory authorities, you will help drive study success while ensuring compliance and operational excellence.

What you will do:

Bring energy, knowledge, innovation and leadership to carry out the following:

• Lead and oversee country-level study start-up activities, including clinical trial submissions, approvals, ethics committee interactions, and regulatory authority communications.
• Manage local study operations, including informed consent, clinical and ancillary supplies, import/export requirements, archiving, insurance processes, and compliance documentation.
• Own country and site budget management, financial compliance, payment processes, and the development, negotiation, and execution of Clinical Trial Research Agreements (CTRAs).
• Collaborate with internal functions including Finance, Legal, Regulatory Affairs, and Pharmacovigilance, as well as external vendors, to ensure timely delivery of study milestones.
• Drive process improvements, contribute to local Standard Operating Procedures, and serve as a Subject Matter Expert for assigned operational topics.
• Support talent development through mentoring, onboarding, while contributing to strategic local initiatives and projects.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Bachelor's Degree in Life Sciences, Business Administration, Finance, Healthcare, or a related discipline.
• Minimum 5 years of experience in clinical research or a combination of clinical research and finance/business operations.
• Strong knowledge of clinical trial regulations, ICH‑GCP, local regulatory requirements, and study start-up processes.
• Proven experience in budget management, contract negotiations, and Clinical Trial Research Agreements (CTRAs).
• Solid understanding of the European Clinical Trials Regulation (EU CTR), including submission requirements and timeline, and of European Union In Vitro Diagnostic Regulation (IVDR).
• Excellent problem-solving and critical thinking skills, with the ability to identify risks, determine root causes, and implement effective solutions.
• Strong communication, stakeholder management, negotiation, conflict resolution, and cross-functional collaboration skills.
• Proficiency in clinical systems, digital technologies, and AI-enabled tools supporting clinical operations.
• Fluent written and verbal communication skills in both Portuguese and English.

Travel: Approximately 15% domestic and international travel may be required.

Why Join Us?

As a company, we keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

Additional location(s) Compensation Information:

Required Skills:
Adaptability, Adaptability, Business Management, Clinical Development, Clinical Information Systems, Clinical Operations, Clinical Research, Clinical Site Management, Clinical Trial Agreements (CTA), Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Planning, Clinical Trials Monitoring, Clinical Trials Operations, Conceptual Thinking, Conflict Management, Critical Thinking, Cross-Cultural Awareness, Data Operations, Good Clinical Practice (GCP), Healthcare Delivery Systems, ICH GCP Guidelines, Lateral Thinking, Liaison Work {+ 7 more}

Preferred Skills:

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):

Job Posting End Date:
11/2/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date.