Associate Country Clinical Quality Manager

hace 6 meses

Bogota, Colombia MSD A tiempo completo

**Job Description**:
Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover the next medical breakthrough.

Under the guidance of the Regional Director Clinical Quality Management Latin America and in close collaboration with the Country Clinical Quality Manager, the Associate Country Clinical Quality Managersupports the oversight of specific Clinical Quality Management related activities in Colombia. Will work in close collaboration with the Clinical Research Director and the local clinical operations team in Colombia.

Specific responsibilities include:
Audits & Inspections: Will support activities during the preparation/ ongoing/follow-up phase of an audit or inspection. In cooperation with the local team and/or headquarters, will support root-cause-analysis for audit/ inspection findings, manage and track the Corrective and Preventive Actions as well as coordinate and facilitate the responses to audit/inspection reports. On a regular basis and in collaboration with the local team, supports during identification of local trends, root-cause-analysis (if necessary) and the development of local action plans.

Processes & Regulations:
Will identify process improvement opportunities and/or process gaps and properly escalate to the Regional Director Clinical Quality Management Latin America and/or headquarters (if necessary). In addition, and as agreed with the Clinical Research Director the Associate Country Clinical Quality Manager supports continuous improvement activities at the local/regional level.

Supports local trainings (as needed).

Supports the coordination and oversight of activities. This includes to ensure a proper execution of the In-house Quality Control Plan as well as the Quality Control Visits. Upon request and in mutual agreement with the Clinical Research Director and the Regional Director Clinical Quality Management, the Associate Country Clinical Quality Manager may also perform QC activities and site visits.

Education: Bachelor's Degree or equivalent in relevant health care area.

**Experience**:

- A minimum of 4-6 years of relevant experience in clinical research including direct field monitoring experience or

management/oversight of such individuals, with a demonstrated record of accomplishments.
- Knowledge and understanding of Clinical Trial processes as well as quality management and control tools.
- Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.
- Experience of participating in cross-functional teams of business professionals. Experience of leading a cross-functional

team is a plus.
- Experience of participating in audits and inspections, preferably with experience in direct support.
- Experience in coordinating and delivering training sessions is a plus.

**Skills**:

- Superior oral and written communication skills in an international environment. - Advanced level English written and

conversational skills.
- Good project management and organizational skills.
- Good team work and leadership skills, including the ability to resolve conflicts.
- Ability to analyze, interpret, and solve problems.
- Ability to think objectively and with creativity and innovation.

LI-DNI

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
No relocation

**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R253147

  • Country Clinical Quality Manager Colombia

    hace 5 meses

    Bogota, Colombia MSD A tiempo completo

    **The Country Clinical Quality Manager** oversees all Clinical Quality Management activities in the respective country/cluster with the objective to delivered and sustained patient safety and high-quality data in compliance with company requirements and regulations. The role requires the ability to properly implement local/global processes/procedures, to...

  • Clinical Research Associate

    hace 5 meses

    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...

  • Clinical Research Manager

    hace 5 meses

    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...

  • Clinical Research Associate

    hace 5 meses

    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...

  • Head Clinical Country Operations

    hace 6 meses

    Bogota, Colombia MSD A tiempo completo

    This role is accountable for execution and oversight of local operational clinical trial activities in compliance with International Conference on Harmonization Good Clinical Practice (ICH/GCP) and country regulations, company policies and procedures and with quality standards internally and externally. The person has ownership, oversight and impact on local...

  • Senior Clinical Research Associate

    hace 5 meses

    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 Research Associate

    hace 5 meses

    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...

  • Clinical Research Associate

    hace 6 meses

    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...

  • Clinical Operation Manager

    hace 5 meses

    Bogota, Colombia MSD A tiempo completo

    This role is accountable for performance and compliance 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. Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for...

  • Senior Clinical Research Associate

    hace 7 meses

    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...

  • Clinical Research Manager

    hace 5 meses

    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 6 meses

    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...

  • Senior Clinical Research Manager

    hace 5 meses

    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...

  • Senior Clinical Research Associate

    hace 5 meses

    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...

  • Clinical Trial Manager

    hace 5 meses

    Bogota, Colombia ICON A tiempo completo

    ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. You will be dedicated resource to one of our clients, be embedded in their working environment,...

  • Sr. or Clinical Trial Manager, Oncology, Columbia

    hace 5 meses

    Bogota, Colombia Novasyte A tiempo completo

    IQVIA Biotech is committed and dedicated to the small biotech & biopharma companies we support. Opportunities available for an experienced Clinical Trial Manager II or Senior Clinical Trial Manager. Previous clinical trial management and CRO experience preferred. Therapeutic requirements/preference: any of the following Oncology/Hematology/CAR T/Cell &...

  • Local Study Associate Director

    hace 5 meses

    Bogota, Colombia AstraZeneca A tiempo completo

    **Description**: The Local Study Associate Director is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived. To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines...

  • Country Solutions Manager

    hace 6 meses

    Bogota, Colombia ADP A tiempo completo

    **SUMMARY** The GlobalView Country Solution Manager for Costa Rica is responsible for overall product delivery. Responsibility is focused on building and maintaining the Costa Rica country template and activities related to defining and managing roadmap priorities through collaboration with internal (and sometimes external) business partners; functional...

  • Local Study Associate Director

    hace 6 meses

    Bogota, Colombia AstraZeneca A tiempo completo

    The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived. To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with AZ Procedural Documents,...

  • Local Study Associate Director

    hace 6 meses

    Bogota, Colombia AstraZeneca A tiempo completo

    The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived. To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with AZ Procedural Documents,...