Clinical Research Manager

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

Resumo da oferta

An established industry player is seeking a Clinical Research Manager to oversee project management for clinical trials in Brazil. This role involves ensuring compliance with regulations, managing local study teams, and collaborating with external partners. The ideal candidate will have solid experience in clinical research and a background in immunology. Join this innovative firm to contribute to impactful studies and enhance your career in a dynamic environment that values scientific excellence and teamwork.

Qualificações

• Solid experience in clinical research management and immunology.
• Experience as CRA monitoring clinical trials.

Responsabilidades

• Main point of contact for assigned protocols and project management.
• Responsible for compliance with ICH/GCP and country regulations.

Conhecimentos

Clinical Research Management

Immunology

Project Management

Formação académica

Bachelor’s degree in Science

Advanced degree in Science/Biology

Descrição da oferta de emprego

Job Description

This role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
For certain studies, the CRM could be responsible for several countries in a cluster.

Responsibilities include, but are not limited to:
• Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
• Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
• Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
o Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
o Performs Quality control visits as required.
• Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration.
• Responsible for creating and executing a local risk management plan for assigned studies.
• Ensures compliance with CTMS, eTMF and other key systems in assigned studies.
• Escalates as needed different challenges and issues to TA Head/CRD/CQM and or CTT (as appropriate).
• Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
• Country POC for programmatically outsourced trials for assigned protocols.
• Serves local business needs as applicable in his/her country (If delegated can sign contracts and manage budgets).
• Collaborates internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his/her studies. GHH to be consulted as needed.
• As a customer-facing role, this position will build business relationships and represent company with investigators.
• Shares protocol-specific information and best practices across countries\clusters.

Eperience Requirements:
• Solid experience with Clinical Research management and experience in immunology therapeutic area
• Solid previous experience as CRA monitoring clinical trials.

Educational Requirements:
• Bachelor’s degree in Science.

Preferred:
• Advanced degree, (e.g. BA/BS or higher) with a strong emphasis in science and/or biology.

• Fluency in English.

ClinicalTrialsBR

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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:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

no

Required Skills:

Preferred Skills:

Job Posting End Date:

05/17/2025

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