Associate Director, Clinical Operations

Job description

Job Description This role is accountable for the execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, company policies and procedures, and internal and external quality standards. Under the oversight of the CRD or Head of Country Operations, the position is responsible for managing and overseeing a team of Clinical Operations Managers (COMs) and/or Clinical Trial Coordinators (CTCs). This role plays a critical role in delivering country-specific clinical trial commitments and objectives, particularly during study start-up, while ensuring operational excellence, compliance, quality, and stakeholder alignment. Key Responsibilities Financial Management Own country and site budgets. Develop, negotiate, and complete Clinical Trial Research Agreements (CTRAs). Partner with local clinical teams to deliver clinical and financial contracts within fair market value guidelines. Oversee and track clinical research-related payments. Manage payment reconciliation at study close-out. Ensure compliance with FCPA requirements, Denied Parties Screening, and financial systems maintenance. Support financial forecasting and operational budget tracking in conjunction with the CRD, where applicable. Regulatory Submissions & Local Documentation Execute and oversee country-level clinical trial submissions and approvals for assigned protocols. Develop local language materials, including: Informed Consent Forms (ICFs) Study-related translations Other required local documentation Collaborate with IRBs/IECs and Regulatory Authorities on submission and approval activities. Operational & Quality Oversight Manage country deliverables, timelines, and protocol outcomes to meet local commitments. Ensure quality and compliance standards are maintained across assigned protocols. Contribute to the development and improvement of local and global SOPs. Oversee contract workers, including COMs, CTCs, and local vendors. Manage direct reports through: Performance management Development planning Coaching and mentoring Issue resolution Stakeholder Management & Collaboration Work closely with internal and external stakeholders to ensure country deliverables are achieved. Internal Stakeholders Clinical Research Managers (CRMs) Clinical Trial Coordinators (CTCs) Clinical Research Associates (CRAs) Clinical Operations Managers (COMs) Clinical Quality Managers (CQMs) Medical Affairs Pharmacovigilance Regulatory Affairs Business Compliance Finance Legal Global and regional functional teams External Stakeholders Investigators Clinical trial sites Vendors Regulatory agencies Ethics committees Other external partners Local Process Management Provide oversight and coordination of: Clinical and ancillary supplies management Import and export requirements Supply destruction processes Local filing systems (electronic and hard copy) Archiving and retention requirements Insurance process management Maintain and update country information within: Clinical systems Regulatory systems Safety systems Financial systems Experience Required Minimum 8 years of clinical research experience. Minimum 2 years of people management or team oversight experience. Core Competencies Leadership & People Management Demonstrated people management skills, including managing teams across countries. Ability to influence investigators, vendors, external partners, and country stakeholders. Proven ability to deliver commitments within timelines and budget with minimal supervision. Clinical & Regulatory Expertise Strong knowledge of: Budget and contract negotiations Local ethics and regulatory requirements Submission and approval processes Development of local informed consent documents Study start-up and ongoing study deliverables Extensive clinical project management experience. Expertise in clinical, regulatory, and financial systems, tools, and metrics. Risk Management & Decision Making Ability to identify risks proactively and implement mitigation plans. Strong problem-solving capabilities. Independent decision-making skills with accountability for outcomes. Communication & Interpersonal Skills Excellent verbal and written communication skills. Strong negotiation and influencing capabilities. Effective coaching, mentoring, and training skills. Organizational Effectiveness Ability to manage multiple protocols and priorities simultaneously. Strong planning, coordination, and organizational skills. Ability to work effectively in global and virtual environments. Language Fluency in English and the local language. Education Required Bachelor's Degree (or equivalent) in: Business Finance Business Administration Life Sciences Healthcare-related discipline Equivalent relevant experience Preferred Master's Degree (or equivalent) in: Business Finance Business Administration Life Sciences Healthcare-related discipline Equivalent relevant experience Team Management Scope Direct management of approximately 6–14 employees (COMs and/or CTCs). Oversight of contractor COMs and CTCs, where applicable. Required Skills: Adaptability, Adaptability, Budget Management, Clinical Research, Clinical Research Management, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Clinical Trials Operations, Cross-Cultural Awareness, Decision Making, Ethical Standards, Financial Accounting, Good Clinical Practice (GCP), Informed Consent, Legal Archiving, Medical Affairs, Oncology Trials, Organizational Performance Management, People Leadership, People Management, Risk Evaluation And Mitigation Strategy (REMS), Risk Management {+ 1 more} 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: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 08/31/2026*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.