MSD Clinical Operations Manager Regulatory 

Argentina, Autonomous City of Buenos Aires, Buenos Aires 

343972896

Job Description

This role is accountable for performance and compliance for assigned protocols in Argentina in compliance with International Conference on Harmonisation Good Clinical Practice (ICH/GCP) and country regulations, our companies' policies and procedures, quality standards and adverse event reporting requirements internally and externally.Under the oversight of the Senior Clinical Operations Manager, Head Clinical Operations Managers or Clinical Research Director, the person is responsible for execution and oversight of clinical trial country submissions and approvals and to ensure Site Readiness.

Responsibilities include, but are not limited to:

• Executes and oversees clinical trial country submissions and approvals for assigned protocols.
• Develops local language materials including local language Informed Consents and translations. Interacts with Institutional Review Board/Institutional Review Committee (IRB/IEC) and Regulatory Authority for assigned protocols.
• Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
• Contributes to the development of local Standard Operating Procedure (SOPs). Oversees Clinical Trial Coordinators (CTC) as applicable.
• Coordinates and liaises with Clinical Research Manager, CTC, Clinical Research Associate (CRA), (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets and local milestones.
• Provide support and oversight to local vendors as applicable.
• Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.
• Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.
• Contribute or lead initiatives and projects adding value to the business, as appropriate/required.
• Contributes strongly to Clinical Operations Management team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
• Contributes to Clinical Operations Management team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required.

Main requirements:

• Bachelor's Degree in Business, Finance, Administration, Life Science or equivalent Health Care related experience;
• Minimum 5 years of experience in clinical research or combined experience in Clinical Research and Regulatory Affairs business;
• Expertise of core clinical systems, tools and metrics;
• Excellent verbal and written skills, in local Spanish and English;
• Strong coordination and organizational skills;
• Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up;
• Ability to make decisions independently with limited oversight from manager;
• Requires strong understanding of local regulatory environment;
• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally;
• Effective and efficient time management, organizational and interpersonal skills, conflict management and problem-solving skills;
• High sense of accountability and urgency in order to properly prioritize deliverables;
• Ability to focus on multiple deliverables and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people;
• Positive mindset, growth mindset, capable of working independently and being self-driven;
• Availability for a hybrid working model, being 3x a week in the Buenos Aires office.

Current Contingent Workers apply

No Travel Required

Not ApplicableNot Indicated

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

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.