Senior Clinical Research Manager

hace 7 días


Bogota, Colombia MSD A tiempo completo

This role is primarily accountable for the end-to-end performance and project management for assigned protocols in compliance with country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally. The Senior Clinical Research Manager could be responsible for a particular study for several countries in a cluster.

**CORE Competency **Expectations**

**Experience Requirements**:
**Required**:
**1. 5-6 years of experience in clinical research - CRA Experience preferred**
**2. Educational Requirements**:
**Bachelor degree in Science (or comparable)**
**Preferred: Advanced degree, (e.g., Master degree, MD, **PHD**

3. Fluent Spanish and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.

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

5. Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.

6. Knowledge in Project Management and site management.

7. Strong organizational skills with demonstrated success required.

8. Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight, and supervision of the TA Head /CRD

9. Requires strong understanding of local regulatory environment

10. Strong scientific and clinical research knowledge is required

11. Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.

12. Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions

13. Strategic thinking

**Search Firm Representatives Please Read Carefully**

**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
**Requisition ID**:R284284


  • Clinical Research Manager

    hace 2 semanas


    Bogota, Colombia MSD A tiempo completo

    **Job Description**: This role is primarily accountable for the end-to-end performance and project management for assigned protocols in compliance with country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally. The Clinical Research Manager could be responsible for a particular study...

  • Clinical Research Manager

    hace 2 semanas


    Bogota, Colombia Novo Nordisk A tiempo completo

    Clinical Research Manager **Category**:Clinical Development**Location**:Bogota, Cundinamarca, CO- **The Position** - As Clinical Research Manager you will manage and coordinate the implementation of local clinical projects, ensuring that are executed in a timely and effective manner, within budget and complying with regulatory requirements, Helsinki...


  • Bogota, Colombia MSD A tiempo completo

    **Job Description**: With support of Sr Clinical Research Associate/Clinical Research Associate and/or Clinical Research Associate Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. - Develops strong site relationships and ensures continuity of site...


  • Bogota, Colombia MSD A tiempo completo

    **Job Description**: We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that...


  • Bogota, Colombia MSD A tiempo completo

    **Job Description**: We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that...


  • Bogota, Colombia MSD A tiempo completo

    **Job Description**: The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the Clinical Research Associate manager the person ensures compliance of study conduct with International Conference on Harmonisation Good Clinical Practice and country regulations, our company policies and...


  • Bogota, Colombia MSD A tiempo completo

    The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as...


  • Bogota, Colombia MSD A tiempo completo

    The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and...

  • Clinical Data Manager

    hace 3 semanas


    Bogota, Colombia MSD A tiempo completo

    **Job Description**: Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. **Position Overview**: Under the direction of the...

  • Clinical Research Manager

    hace 2 semanas


    Bogota, Colombia MSD A tiempo completo

    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. The CRM could be responsible for a particular study for...

  • Clinical Research Manager

    hace 2 semanas


    Bogota, Colombia MSD A tiempo completo

    **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. The CRM could be responsible for a...


  • Bogota, Colombia Novo Nordisk A tiempo completo

    Senior Clinical Research Associate **Category**:Clinical Development**Location**:Bogota, Cundinamarca, CO- **The Position** - The Senior CRA will manage and execute the entire Novo Nordisk clinical trials process in compliance with internal SOPs including GCP-ICH and Colombia regulatory framework.**Activities and Responsibilities** - Clinical Trials...


  • Bogota, Colombia MSD A tiempo completo

    The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as...


  • Bogota, Colombia MSD A tiempo completo

    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. The CRM could be responsible for a particular study for...

  • Clinical Research Manager

    hace 4 semanas


    Bogota, Colombia MSD A tiempo completo

    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. The CRM could be responsible for a particular study for...


  • Bogota, Colombia MSD A tiempo completo

    **Job Description**: The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements internally and...

  • Clinical Research Manager

    hace 4 semanas


    Bogota, Colombia MSD A tiempo completo

    **Clinical Research Manager (CRM)** 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, Merck/MSD policies and procedures, quality standards and adverse event reporting requirements internally and externally. The CRM could be...


  • Bogota, Colombia MSD A tiempo completo

    The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, Merck/MSD policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts...


  • Bogota, Colombia MSD A tiempo completo

    The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the Clinical Research Associate manager the person ensures compliance of study conduct with International Conference on Harmonisation Good Clinical Practice and country regulations, our company policies and procedures, quality...


  • Bogota, Colombia MSD A tiempo completo

    The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as...