31 oct
|
Msd
|
Vicente López
Clinical Operations Manager*This site uses cookies to provide you with an optimal user experience. The cookies include Strictly Necessary and Functional cookies to ensure the site operates as intended (language preference, time zone and workload balance). These cookies are first party cookies, end with the session and are exempted from consent. In addition, this site also uses a Google Analytics Cookie to measure and improve the performance of our site. All information these cookies collect is aggregated and therefore anonymous. By clicking on the ‘Accept Cookies’ button, you are accepting this Performance cookie. You may use this site if you click on the ‘Reject Cookies’ button. To revoke your consent of the Performance cookie, clear your cookies within your browser settings.*### Clinical Operations ManagerApply: Not Applicable: ARG
- Buenos Aires
- Munro: Full time: Posted Today: End Date: November 6, 2026 (8 days left to apply): R424358Job DescriptionThis role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Under the oversight of the Linemanager, the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready. Responsibilities include, but are not limited to:
• Ownership of country and site budgets. Development, negotiation and completion of ClinicalTrial Research Agreements (CTRA).
• Oversees and tracks clinical research-related payments. Payment reconciliation at study closeout. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Financialforecasting in conjunction with Sr.
COM /other roles.•Executes and oversees clinical trial country submissions and approvals for assigned protocols.
• Develops local language materials including local language Informed Consents andtranslations. Interacts with IRB/IEC and Regulatory Authority for assignedprotocols.
• Manages country deliverables, timelines and results for assigned protocols to meet countrycommitments. Responsible for quality and compliance in assigned protocols in country.
• Contributes to the development of local SOPs. Oversees CTCs as applicable.
• Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensurecountry deliverables are obtained for submissions, budgets, CTRAs and localmilestones. Collaborates closely with Headquarter to align country timelines forassigned protocols.•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 copyfiling, archiving and retention requirements, and insurance process management. Entersand updates country information in clinical and finance systems.
• Ownership of local regulatory and financial compliance. The position has a significant impact onhow a country can deliver country-specific trial commitments and objectives especially duringstudy start-up.
• Required to in/directly influence investigators,
external partners and country operations andadheres to budget targets and agreed payment timelines.
• Works in partnership internally with GCTO country operations, finance, regulatory affairs,pharmacovigilance, legal and regional operations, HQ functional areas and externally withvendors and sites, IRB/IECs and Regulatory Authorities in submission and approvalrelated
- interactions. Through continual interaction with local clinical team/s successfullydelivers clinical and financial contracts within fair market value.
• Contribute or lead initiatives and projects adding value to the business, as appropriate/required.
• Contributes strongly to COM team and other Country Operations roles knowledge by acting asprocess Subject Matter Expert (SME), sharing best practices, making recommendations forcontinuous improvement and providing training as appropriate/required.
• Contributes to COM team knowledge by acting as buddy/mentor and sharing best practices asappropriate/required. Core competencies:
• Expertise of core clinical systems, tools and metrics
• Excellent verbal and written influencing and training/mentoring skills, in local language 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 indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the Sr.
COM or manager.
• Ability to make decisions independently with limited oversight from Sr.
COM or manager.
• Requires strong understanding of local regulatory environment
• Ability to proact
📌 Clinical Operations Manager (Vicente López)
🏢 Msd
📍 Vicente López