Clinical Research Manager

Clinical Research Manager
Компания: Merck & Co., Inc.
Город: Sao Paulo
Job Description
Our Global Clinical Trial team is at the heart of advancing our clinical development portfolio, turning science into meaningful outcomes for patients. We are looking for a Clinical Research Manager (CRM) to drive the end-to-end execution of clinical studies in Brazil.
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, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
**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, Our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
* Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
* 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.
* 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 Our Company with investigators
* Shares protocol-specific information and best practices across countries\\clusters
**
Required Experience**
* Proven hands-on experience in end-to-end management of sponsor-led Phase I–III clinical trials, beyond site monitoring activities.
* Experience managing large-scale and/or highly complex clinical trials, including megatrials.
* Experience with complex study designs and operational models, with greater emphasis on study type, scale and complexity than on a specific therapeutic area.
* Strong knowledge of ICH-GCP, clinical research regulations and quality standards.
* Strong project management, risk management and cross-functional stakeholder management capabilities
Required:
* Bachelor degree in Science (or comparable)
* English Proficiency
Preferred:
Advanced degree, (e.g., Master degree, MD, PhD)
"Temos orgulho de ser uma empresa que acredita no valor de trazer pessoas de diferentes perfis, talentosas e comprometidas. A maneira mais rápida de revolucionar a inovação é quando ideias diversas se reúnem em um ambiente inclusivo. Incentivamos nossos colaboradores a abordar os problemas coletivamente e desafiar de forma respeitosa o raciocínio uns dos outros. Somos um empregador focado em promover iguais oportunidades aos nossos colaboradores, comprometido a incentivar um local de trabalho inclusivo e diversificado."
**Additional location(s) Compensation Information:**
**Required Skills:**
Clinical Data Management, Clinical Research, Clinical Site Management, Clinical Trial Management, Good Clinical Practice (GCP), Risk Based Monitoring, Strategic Planning, Strategic Thinking, Vendor Management
**Preferred Skills:**
Current Employees apply [HERE](https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply [HERE](https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
**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:**
Hybrid
**Shift:**
**Valid Driving License:**
**Hazardous Material(s):**
**Job Posting End Date:**
11/18/2026
**\*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.**