Associate Country Clinical Quality Manager

hace 4 semanas

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

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