Executive Director Clinical Trial Operations The Clinical Research Director (CRD) is the Clinical Operations lead in a country / cluster and is responsible for execution of all Clinical Trials in scope for General Clinical Trial Operations (GCTO) country operations. Adherence to GCP local and global policies and procedures to conduct high-quality inspection ready studies is essential. The position is accountable for trial quality and audit responses and completion of CAPAs. The incumbent ensures a single point of contact for managing clinical trial execution in all its aspects across phases in scope of GCTO within the country / cluster. The position has multiple touch points across the company which will be dependent on country / cluster and the study type and stage. Supports the regional GCTO leadership team leading strategic development of their country / cluster to deliver clinical trials as per global clinical research pipeline requirement Build and lead the team to effectively manage resources ensuring appropriately skilled and high performing team to effectively deliver the portfolio across therapy areas and achieve on agreed GCTO GCD and Research Division objectives Leads strategic development and management of institutional & investigator relationships in conjunction with Research Division / GCD Therapy Areas and when appropriate Human Health Working with regional and global colleagues develops and executes the GCTO strategy for the country / cluster - such as Industry associations Leadership and Management of the GCTO country / cluster Organization : Proactively identifies new opportunities and gaps to support emerging needs and addresses by reallocating and training of existing staff and / or external recruitment Builds a culture of quality and compliance through training oversight and collaboration Oversight to ensure appropriate scientific and operational training for staff members. Clinical Operation Management : Ensures a single point of contact for managing clinical trial execution in all its aspects across all studies & phases in scope of GCTO within the country / cluster. Approved administrative budget to support GCTO team (e.G. salaries & travel)Country level operational study budgets responding to inquiries by health authorities ethics committees and internal auditors in conjunction with CCQM compliance Regulatory Pharmacovigilance (PV) and Medical Affairs Significant Management experience in clinical trials with a pharmaceutical organisation with the ability to service and collaborate with different stakeholders within GCTO and the wider Research division in a matrix organization Management expertise should cover management of budget travel resources headcount processes (and controls) productivity quality and project delivery A complete understanding of ICH GCP and Global / Regional / Local regulatory requirements is required. Strong Communication skills requiring proficiency in written and spoken English and preferably local language. Merck & Co. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. Relocation : VISA Sponsorship : Flexible Work Arrangements : Shift : Adaptability Budget Management Clinical Research Organizations (CRO) Management Clinical Trial Planning Clinical Trials Monitoring Clinical Trials Operations Cross-Cultural Awareness Ethical Standards ICH GCP Guidelines Mentorship People Leadership Resource Allocation Results-Oriented Risk Management Strategic Thinking Employee Relations,Employee Evaluation,Management Experience,Profit & Loss,Conflict Management,Operations Management,Project Management,Budgeting,Leadership Experience,Supervising Experience,Leadership management,Financial Planning Employment Type : Full-Time