Sr. Clinical Trial Coordinator

Merck; São Paulo; Híbrido; BRL 60.000 - 100.000; Tempo integral

Resumo da oferta

Join a forward-thinking company as a Senior Clinical Trial Coordinator, where your expertise in clinical research will make a significant impact. In this role, you'll oversee the administration of clinical trials, ensuring compliance and quality throughout the process. Collaborate with a dedicated team to manage essential documents and support regulatory submissions, while mentoring junior coordinators. This innovative firm offers a hybrid work environment, allowing you to balance your professional and personal life while contributing to groundbreaking research that improves lives. If you're ready for a rewarding challenge, apply now!

Qualificações

• Experience in pharmaceutical companies and/or Clinical Research Organizations (CROs).
• Ability to manage clinical documents and ensure compliance.

Responsabilidades

• Track essential documents and safety reports for clinical trials.
• Prepare and archive clinical documents, including eTMF.
• Support submission packages for review boards and regulatory agencies.

Conhecimentos

Clinical Trial Management

Document Management

Regulatory Submissions

Collaboration

Advanced English

Formação académica

Bachelor’s degree in Health or Life Science

Ferramentas

Clinical Trial Management System

Descrição da oferta de emprego

Are you passionate about clinical research and looking to make a significant impact?

We are seeking a Senior Clinical Trial Coordinator to join our team! In this role, you will be responsible for comprehensive trial and site administration, ensuring the smooth operation of clinical trials. If you thrive in a collaborative environment and are committed to excellence, this opportunity is for you!

Main Responsibilities include, but are not limited to:

• Track essential documents and safety reports, ensuring timely collation and distribution of study tools and documents.
• Update clinical trial databases (Clinical Trial Management System) and manage clinical and non-clinical supply in collaboration with other country roles.
• Prepare and archive clinical documents, including the electronic Trial Master File (eTMF), and assist with eTMF reconciliation and quality control.
• Manage labeling requirements and coordinate translation change requests as needed.
• Provide and collect forms/lists from investigators for site evaluation, start-up, and submissions, while obtaining and tracking study insurance certificates.
• Support the preparation of submission packages for Institutional Review Boards/Ethics Review Committees and regulatory agency submissions.
• Organize meetings, including creating and tracking study memos, letters, and protocols, and support local investigator meetings.
• Act as a Subject Matter Expert (SME) to share best practices, recommend continuous improvements, and mentor junior Senior Clinical Trial Coordinators.

Main Requirements:

• Bachelor’s degree in a Health or Life Science field.
• Solid experience in pharmaceutical companies and/or Clinical Research Organizations (CROs).
• Advanced English skills.

If you are ready to take the next step in your career and contribute to impactful clinical research, apply now and join us in making a difference!

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

Job Description

Are you passionate about clinical research and looking to make a significant impact?

We are seeking a Senior Clinical Trial Coordinator to join our team! In this role, you will be responsible for comprehensive trial and site administration, ensuring the smooth operation of clinical trials. If you thrive in a collaborative environment and are committed to excellence, this opportunity is for you!

Main Responsibilities include, but are not limited to:

• Track essential documents and safety reports, ensuring timely collation and distribution of study tools and documents.
• Update clinical trial databases (Clinical Trial Management System) and manage clinical and non-clinical supply in collaboration with other country roles.
• Prepare and archive clinical documents, including the electronic Trial Master File (eTMF), and assist with eTMF reconciliation and quality control.
• Manage labeling requirements and coordinate translation change requests as needed.
• Provide and collect forms/lists from investigators for site evaluation, start-up, and submissions, while obtaining and tracking study insurance certificates.
• Support the preparation of submission packages for Institutional Review Boards/Ethics Review Committees and regulatory agency submissions.
• Organize meetings, including creating and tracking study memos, letters, and protocols, and support local investigator meetings.
• Act as a Subject Matter Expert (SME) to share best practices, recommend continuous improvements, and mentor junior Senior Clinical Trial Coordinators.

Main Requirements:

• Bachelor’s degree in a Health or Life Science field.
• Solid experience in pharmaceutical companies and/or Clinical Research Organizations (CROs).
• Advanced English skills.

If you are ready to take the next step in your career and contribute to impactful clinical research, apply now and join us in making a difference!

#LI-DNI

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

50%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/14/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.