Clinical Operations Manager Regulatory - Supply (Fixed Term) MSD LATAM Bogota, D.C., Capital District, Colombia Join or sign in to find your next job Join to apply for the Clinical Operations Manager Regulatory - Supply (Fixed Term) role at MSD LATAM Clinical Operations Manager Regulatory - Supply (Fixed Term) MSD LATAM Bogota, D.C., Capital District, Colombia 1 day ago Be among the first 25 applicants Join to apply for the Clinical Operations Manager Regulatory - Supply (Fixed Term) role at MSD LATAM Get AI-powered advice on this job and more exclusive features. Job Description This role is accountable for performance and compliance for assigned protocols in a country, ensuring adherence to ICH/GCP, country regulations, company policies, quality standards, and adverse event reporting requirements. Under the oversight of the Sr. COM, Head COMs, or CRD, the person is responsible for budget/finance aspects, clinical trial country submissions and approvals, and site readiness. Responsibilities include, but are not limited to: Ownership of country and site budgets, development, negotiation, and completion of Clinical Trial Research Agreements (CTRA). Overseeing and tracking clinical research-related payments, payment reconciliation, and maintaining financial systems. Conducting financial forecasting in collaboration with senior roles. Executing and overseeing clinical trial country submissions and approvals for assigned protocols. Developing local language materials including informed consents and translations, and interacting with IRB/IEC and regulatory authorities. Managing country deliverables, timelines, and results for protocols to meet commitments, ensuring quality and compliance. Contributing to local SOPs and overseeing CTCs as applicable. Coordinating with CRM, CTC, CRA, and other stakeholders to ensure timely submissions, budgets, CTRAs, and milestones. Collaborating with headquarters to align timelines. Supporting and overseeing local vendors, managing local processes related to supplies, import/export, destruction, filing, archiving, and insurance. Updating country information in systems. Ensuring local regulatory and financial compliance, impacting study start-up and delivery of trial commitments. Influencing investigators, vendors, partners, and country operations while adhering to budgets and timelines. Working with internal teams and external vendors, IRB/IECs, and authorities to facilitate submissions and approvals. Delivering contracts within fair market value. Leading initiatives, sharing best practices, and mentoring team members to foster continuous improvement and knowledge sharing. Core competencies include expertise in clinical systems, influencing skills, organizational skills, budget negotiations, regulatory understanding, decision-making, risk management, and team leadership. Behavioral competencies focus on problem-solving, time management, accountability, communication, leadership, adaptability, and influencing skills. Requirements include at least 5 years of experience in clinical research or combined in research and finance/business, and a Bachelor's Degree in relevant fields. This is a project-based fixed-term role with no relocation or visa sponsorship, requiring 10% travel and offering a hybrid work arrangement. Application deadline is 08/9/2025. #J-18808-Ljbffr