Senior Specialist, Clinical Supply Project Manager - Protocol - Hybrid

Protocol Clinical Supplies Project Manager The Global Clinical Supply (GCS) organization manages the end‑to‑end integrated clinical supply chain across the company's research laboratories portfolio of clinical trials. The GCS Planning organization interfaces between clinical development teams and operational/executional arms. The Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities associated with clinical supplies for assigned studies. Key Responsibilities Act as a key stakeholder on Clinical Trial Teams, collaborating with functional representatives to negotiate timelines and strategies for clinical supplies. Coordinate with clinical development, regulatory, quality, and supply chain partners to address supply chain and change management issues. Establish timelines for clinical‑supply needs per study and drive sourcing, manufacturing, packaging, and distribution cycles. Analyze and anticipate clinical study risks related to supply chain deliverables, developing mitigation strategies. Utilize tools and systems such as IRT, Microsoft PowerApps, SWMS, Veeva, MEDS, MyLearning, and other Microsoft applications for supply management. Work in the SAP system to create consolidated forecasts for bulk drug product and clinical finished goods. Author clinical supply documentation for labeling, packaging, and regulatory activities. Prepare and present clinical supply information at investigator meetings and study protocol development. Collect and analyze clinical supply chain metrics; support critical non‑pipeline activities. Participate in Interactive Voice Response (IVR) system development and User Acceptance Testing (UAT). Initiate and process change controls, deviations, and investigations in collaboration with GCS Planning. Support regulatory agency inspections for assigned trials. Apply strategic thinking, risk decision making, tactical execution, customer focus, rapid disciplined decisions, and ethics & integrity. Required Experience and Skills Bachelor's degree in scientific, business, or related discipline. At least 5 years of project management experience. At least 5 years of experience in planning, scheduling, coordination, and processing of supply chain activities. Excellent communication and interpersonal skills, including negotiation and relationship building. Project management knowledge of clinical customer relationship management. Technical proficiency in supply chain systems such as SAP or Oracle, demand planning principles, Microsoft Excel, PowerPoint, and Word. Strong analytical and problem‑solving skills to analyze data, identify trends, and optimize processes. Flexibility and adaptability to thrive in a fast‑paced dynamic environment. Detail oriented organization, multitasking, and strong prioritization. Continuous improvement mindset with initiative in process efficiency. Proficiency in ERP systems, demand planning tools, and inventory management systems. Proven record in project/portfolio management. Knowledge of GMP and GCP desirable. Preferred Experience and Skills Results‑orientation and proven execution on collaborative projects. Knowledge of order management, supply chain operations, and document control. Benefits and Compensation Salary range: $117,000.00 – $184,200.00. Eligible for annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, and sick days. Comprehensive benefits information available through the company's benefits portal. Equal Employment Opportunity Statement As an equal opportunity employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. We comply with all affirmative action requirements for protected veterans and individuals with disabilities. #J-18808-Ljbffr Merck & Co.