Senior Specialist - Clinical Supply Project Manager - Protocol - Hybrid

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Northern (KY)

Hybrid

USD 117,000 - 184,000

Full time

4 days ago
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Job summary

Merck is seeking a Senior Specialist - Clinical Supply Project Manager near West Point, PA. You will design strategic and operational plans for clinical supplies, coordinating with clinical development, regulatory, quality and supply chain teams to ensure stable product supply.

The role requires strong project management, data analysis, and ERP experience, with collaboration across development partners to manage timelines, changes, and regulatory readiness in a fast-paced environment.

Qualifications

  • Bachelor's degree in scientific, business, or related discipline required.
  • At least 5 years of experience in project management.
  • Experience in planning, scheduling and processing supply chain activities.

Responsibilities

  • Participates as a key stakeholder on the Clinical Trial Teams (CTT) and collaborates to set timelines and strategy for clinical supplies.
  • Interacts with clinical development, regulatory, quality and supply chain to address topics.
  • Establishes timelines for clinical supply needs per study and coordinates sourcing, manufacturing, packaging and distribution.
  • Analyzes risks to clinical supply and develops mitigation strategies with partners and senior leaders.
  • Uses SAP and other tools to generate a consolidated forecast for study product needs.
  • Authoring of clinical supply documentation and study protocol sections.
  • Supports change controls and deviation investigations as required.
  • Contributes to regulatory inspections and process improvements.

Skills

Analytical Thinking
Clinical Supplies Management
Clinical Supply Chain Management
Clinical Trial Management
Data Analysis
Materials Requirements Planning (MRP)
Project Management
Stakeholder Management
Strategic Planning
Supply Chain Communication
Decision Making

Education

Bachelor's degree in scientific, business, or related discipline

Tools

SAP
Oracle
MS Excel
PowerPoint
MS Word

Job description

# Senior Specialist - Clinical Supply Project Manager - Protocol - HybridMerckWest Point, PAFull-TimeOct 07, 2026Management## Job Description**Job Description**The Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full our company 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.Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities associated with clinical supplies for their assigned studies, which could vary in complexity. This individual serves as the primary GCS point of contact to stakeholders both internal and external to GCS and serves as the GCS spokesperson at clinical development related meetings (i.e., Clinical Trial Teams) and productdevelopment related meetings. The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (i.e. clinical development, CMC, supply chain, & human health), and balancing needs of patients & ensuring stable supply of product.**Primary activities include, but are not limited to:*** 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 development products and 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.**Qualifications, Skills & Experience****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. GCScareer26#eligibleforERP**Required Skills:**Analytical Thinking, Clinical Supplies Management, Clinical Supply Chain Management, Clinical Trial Management, Data Analysis, Materials Requirements Planning (MRP), Project Management, Stakeholder Management, Strategic Planning, Supply ChainCommunication, Decision Making$117,000.00 - $184,200.00RegularNo relocationNo10%Hybrid1st - DayNoNo10/21/2026
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