Assoc. Dir, Clin. Operations

Job description

Job Description This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company's policies and procedures, quality standards, and adverse event reporting requirements internally and externally. For certain studies, the CRM could be responsible for several countries in a cluster. Responsibilities include, but are not limited to: Main Point of Contact (POC) for assigned protocols and link between Country Operations and Clinical Trial Team (CTT). Responsible for project management of the assigned studies: proactively plans, drives, and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution, and close-out. Accountable for performance of assigned protocols in a country in compliance with ICH/GCP and country regulations, our company's policies and procedures, quality standards, and adverse event reporting requirements internally and externally. Reviews Monitoring Visit Reports and escalates performance issues and training needs to CRA Manager and/or functional vendor and internal management as needed. Performs Quality Control visits as required. Leads local study teams to high performance: trains other local roles on the protocol, closely collaborates with and supports CRAs as protocol expert, and coordinates activities across the different local country roles, ensuring strong collaboration. Responsible for creating and executing a local risk management plan for assigned studies. Ensures compliance with CTMS, eTMF, and other key systems in assigned studies. Escalates challenges and issues as needed to TA Head/CRD/CQM and/or CTT (as appropriate). Responsible for collaboration with functional outsourcing vendors, investigators, and other external partners in assigned studies. Country POC for programmatically outsourced trials for assigned protocols. Serves local business needs as applicable in his/her country (if delegated, can sign contracts and manage budgets). Collaborates internally with HQ functions and locally with PV, Regulatory, and GMA to align on key decisions in his/her studies. GHH to be consulted as needed. As a customer-facing role, this position will build business relationships and represent our company with investigators. Shares protocol-specific information and best practices across countries/clusters. Qualifications & Experience Required Experience in Clinical Research. Solid experience as a Clinical Project Manager for interventional trials. CRA experience. Advanced English proficiency. Educational Requirements Required Bachelor’s degree in Science (or comparable). Preferred Advanced degree (e.g., Master's degree, MD, PhD). Temos orgulho de ser uma empresa que acredita no valor de trazer pessoas de diferentes perfis, talentosas e comprometidas. A maneira mais rápida de revolucionar a inovação é quando ideias diversas se reúnem em um ambiente inclusivo. Incentivamos nossos colaboradores a abordar os problemas coletivamente e desafiar de forma respeitosa o raciocínio uns dos outros. Somos um empregador focado em promover iguais oportunidades aos nossos colaboradores, comprometido a incentivar um local de trabalho inclusivo e diversificado. ClinicalTrialsBR Additional location(s) Compensation Information: Required Skills: Adaptability, Clinical Data Management, Clinical Research, Clinical Site Management, Clinical Trial Management, Customer Communications, Decision Making, Good Clinical Practice (GCP), Prioritization, Project Management, Risk Based Monitoring, Risk Management, Strategic Planning, Strategic Thinking, Task Management, Team Leadership, Vendor Management Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully 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: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): no Job Posting End Date: 10/27/2026*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.