Associate Country Clinical Quality Manager, Colombia Job

Date: Jun 23, 2019

Location: Bogotá, CO

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Requisition ID: CLI008398

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.



Under the guidance of the Regional Director Clinical Quality Management Latin America (RCQM LA) and in close collaboration with the Country Clinical Quality Manager (CCQM), the Associate Country Clinical Quality Manager (ACCQM) supports the oversight of specific Clinical Quality Management (CQM) related activities in Colombia. The ACCQM will work in close collaboration with the Clinical Research Director (CRD) and the local clinical operations team in Colombia. 

Specific responsibilities include:

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

Processes & Regulations: The ACCQM will be a local expert for ICH-GCP and local regulations. In close collaboration with the CRD, the ACCQM support the CCQM in managing the local SOP/SME network to ensure a proper implementation of global/local procedures and the regular update of local SOPs. The ACCQM will also identify process improvement opportunities and/or process gaps and properly escalate to the RCQM LA and/or headquarters (if necessary). In addition, and as agreed with the CRD and RCQM LA, the ACCQM supports continuous improvement activities at the local/regional level.

Training: The ACCQM supports local trainings (as needed). 

Quality Control (QC) Activities: The ACCQM supports the CCQM in the coordination and oversight of all QC activities. This includes to ensure a proper execution of the In-house Quality Control Plan (IHQCP) as well as the Quality Control Visits (QCVs). Upon request and in mutual agreement with the CRD and the RCQM LA, the ACCQM may also perform QC activities and site visits. On a regular basis and in collaboration with the local team, supports the CCQM during identification of local trends, root-cause-analysis (if necessary) and the development of local action plans. 


Qualifications

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. 


Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.






Job: Clinical Research Generic
Other Locations:
Employee Status: Regular
Travel: Yes, 15 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Hazardous Materials:
Company Trade Name: MSD


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