Associate Country Clinical Quality Manager Italy

Job Description

The Associate CCQM ensures, under the guidance of the Regional Director, Clinical Quality Management (RCQM) and in close collaboration with the Country Clinical Quality Manager (CCQM) that patient safety, high quality data and compliance with company requirements and regulations are guaranteed. The role supports the oversight of specific CQM activities in the respective country/cluster by properly implementing local/global processes/procedures, identifying opportunities for process improvement, and driving continuous improvement initiatives. Additionally, the Associate CCQM supports audits, inspections, as well as Quality Control and local training activities.

Responsibilities include but are not limited to the following key activities:

• Local expert for ICH-GCP and local regulations (incl. impact assessment of new/updated local regulations on local processes).
• Supports the CCQM in managing the local network of owners/Subject Matter Experts (SMEs) for global/local processes and the regular update of local Standard Operating Procedures (SOPs).
• Identifies process improvement and continuous quality improvement activities.
• Supports local training sessions.
• Coordinates and oversees all QC activities.
• Performs QC activities (incl. QCVs) and conducts ad hoc site visits upon request.
• Supports the identification of local trends, root-cause analysis (if necessary), and the development of local action plans (incl. sharing of results and training of local country operations, if required).
• Assists during the preparation/ongoing/follow-up phase of an audit or inspection.
• Supports root-cause analysis for audit observations/inspection findings, manages and tracks the Corrective and Preventive Actions (CAPAs), and coordinates/facilitates responses to audit/inspection reports.
• Communicates/escalates quality/compliance issues (incl. any potential trends).
• Escalates significant quality/compliance issues per company process and supports investigations.
• Local POC for Privacy management in clinical trials.
• Evaluates trends on Clinical Supply GCP Inquiries and incorrect management of clinical supplies.
• Coordinates GCP Investigations of trends related to Clinical Supply GCP Inquiries and incorrect management of clinical supplies (if necessary).
• Supports local/regional initiatives/projects upon request of the RCQM.

Your profile:

• Bachelor's Degree or equivalent in relevant health care area;
• 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 is required;
• 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 direct support experience;
• Experience of coordinating and delivering training sessions is a plus;
• Good project management, organizational and prioritization skills;
• Good teamwork 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.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position-specific. Please, no phone calls or emails.

Employee Status: Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements: Remote

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date: 01/24/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R331550