Requisition ID: CLI008193
MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125:year legacy. MSD's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
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 ACCQM support the oversight of specific Clinical Quality Management (CQM) related activities in Argentina. The ACCQM will work in close collaboration with the Clinical Research Director (CRD) and the local clinical operations team in Argentina.
Specific responsibilities include:
:Audits and 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 and 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 plansQualifications
Education: Bachelors 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.
: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.Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to
