Senior Specialist, Clinical Supply Project Manager - Protocol - Hybrid

Job Description The Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across our Company's Research Laboratories portfolio of clinical trials. GCS is accountable for the planning, sourcing, labeling, packaging and delivery of clinical supplies to clinical sites globally. The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the business. Primary Activities Participates as a key stakeholder on the Clinical Trial Teams (CTT) and collaborates closely with other functional area representatives to negotiate timelines and strategy for clinical supplies. Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address clinical supply and/or change management related topics. Responsible and accountable for establishing the timelines for clinicalsupplyneedsper study and providingthe signal for sourcing, manufacturing, packaging, and distribution for our Company's development products and our Company's non-marketed products. Analyzes and anticipates clinical study risks as they relate to clinical supply chain deliverables and prepares, analyses, and/or develops mitigation strategies for review with clinical partners and senior leaders. Responsible and accountable for utilizing key tools/systems such as IRT & Microsoft PowerApps, SWMS, Veeva, MEDS, MyLearning, and other Microsoft Applications in the management of clinical supplies for assigned studies. Works directly in the SAP system to establish a consolidated, visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods). Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply chain documentation to support critical CMC activities. Responsible for authoring the Clinical Supplies section of the study protocol as well as preparation and presentation of the clinical supplies information at Investigator Meetings for assigned protocols. Support the collection of clinical supply chain metrics and/or participate in critical non-pipeline activities. Participate in Interactive Voice Response (IVR) Systemdevelopment and User Acceptance Testing (UAT) for assigned studies. Participates in initiation and timely processing of change controls through collaboration with GCS Planning and other cross functional stakeholders and in accordance with established GCS planning SOPs/BPs and QMS Topic 3.4 Change Control Procedures and Work Instructions. Participates in authoring and timely processing of deviation records as well as supports deviation investigations as required. Participates in critical non-pipeline and compliance activities in support of GCS Planning (e.g., process improvement initiatives, subject matter expert roles, SOP/BP development/maintenance, cross functional projects, etc.) Participates in supporting regulatory agency inspections for assigned trials as required. Demonstrates high capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, & influence portfolio decisions with facts and data Demonstrates ability to balance strategy with ability for tactical execution and has strong ownership & accountability of assigned work Focus on Customers & Patients. Make rapid, disciplined decisions. Demonstrates Ethics & Integrity. Required Experience and Skills Bachelor’s Degree in scientific, business, or related discipline required. At least 5 years of experience in project management At least 5 years of experience in planning, scheduling, coordination and processing of supply chain activities, or the equivalent Excellent Communication & Interpersonal Skills: ability to effectively communicate with stakeholders at various levels, including cross-functional teams, senior management, external vendors, and clinical sites. Strong negotiation, influencing, and relationship-building skills to ensure alignment and collaboration in the supply planning process. Project Management Skills: strong knowledge of the principles of project management and clinical customer relationship management. Technical Proficiency: familiarity with supply chain systems and software (e.g. SAP or Oracle) and demand planning principles as well as Microsoft Excel, PowerPoint, and Word Strong Analytical & Problem Solving Skills: ability to analyze complex data, identify trends, and make data-driven decisions to optimize supply chain processes. Flexibility & Adaptability: Demonstrates ability to thrive in a fast-paced and dynamic environment, with the capability to adapt quickly to changing business needs and priorities. Detail Oriented & Organized: strong attention to detail in managing complex supply chain activities; ability to multitask, prioritize tasks, and meet tight deadlines. Continuous Improvement Mindset: Proactive approach to identify process inefficiencies, develop solutions, and drive continuous improvement initiatives within the clinical supply planning function. Proficiency in using supply chain management systems and software, including experience with ERP systems (e.g., SAP), demand planning tools, and inventory management systems. Proven record in project / portfolio management. Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) is highly desirable. Preferred Experience and Skills Results-orientation with the proven ability to execute on collaborative projects and develop subject matter expertise Knowledge of order management, supply chain operations and document control Required Skills Adaptability Business Risks Change Management Clinical Development Clinical Supplies Management Clinical Supply Chain Management Clinical Trial Management Complex Data Analysis Cross-Functional Leadership Data Analysis Demand Planning Detail-Oriented Deviation Investigations Good Manufacturing Practices (GMP) Interpersonal Relationships Key Performance Indicators (KPI) Materials Requirements Planning (MRP) Portfolio Management Process Improvement Projects Project Management Risk Management Senior Program Management Supply Chain Optimization Supply Chain Systems {+ 1 more} Preferred Skills Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. Equal Employment Opportunity Statement As an Equal Employment 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. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit EEOC Know Your Rights and EEOC GINA Supplement. Salary Range The salary range for this role is $117,000.00 - $184,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. Benefits We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at Application Process You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance 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. Employment Details Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: Yes Hazardous Material(s): No Job Posting End Date: 06/3/2026 Requisition ID: R398331 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. #J-18808-Ljbffr Merck