Senior Specialist, Clinical Supply Project Manager - Inventory Manager – Hybrid

Merck•Upper Gwynedd Township, PA

5d•$117,000 - $184,200•Hybrid

About The Position

The Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full portfolio of clinical trials. GCS is accountable for the planning, sourcing, labelling, 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. This role works within the Planning Execution and Inventory Management Section of the GCS Planning organization. Working independently, the Inventory Manager Clinical Supplies Project Manager (IM CSPM) creates strategic and operational plans associated with the downstream activities of clinical supplies for their assigned studies. The primary function of the IM CSPM is planning the availability of materials and subsequent movement through our depot network and further through to distribution and management of materials to the clinical site. 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.

Requirements

Bachelor’s Degree in business, supply chain management, engineering or scientific discipline or High School Diploma with 10+ years equivalent industry experience in Pharmaceutical Clinical Supply (packaging, labeling, logistics and clinical supply inventory management)
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.

Nice To Haves

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.

Responsibilities

Participates on the Clinical Trial Team (CTT) and collaborates closely with other functional area representatives to negotiate timelines and strategy for clinical supplies.
Interacts with key partners in both GCS (Logistics and Trade, Distribution, Operations etc.) as well as other organizations such as Global Clinical Trial Operations (GCTO) headquarter and regional colleagues and Global Development Quality (GDQ) to address clinical supply related topics.
Responsible and accountable for establishing the timelines for clinical supply needs per protocol and ensuring a robust signal for packaging and distribution for Clinical Finished Goods (CFGs).
Analyzes and anticipates clinical study risks as they relate to clinical supply chain deliverables and prepares, analyzes, 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 ensure a robust and consolidated forecast for CFGs is maintained.
Report clinical supply chain incidents to support the gathering of metrics in GCS to describe business health. Participate in root causing to identify areas for operational improvement.
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.