Sr. Specialist – Clinical Supply Project Manager – Protocol

Sr. Specialist – Clinical Supply Project Manager – Protocol

Requirements

• 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.

Responsibilities

• 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 related topics.
• Responsible and accountable for establishing the timelines for clinical supply needs per study and providing the signal for sourcing, manufacturing, packaging, and distribution for our Company’s development products and non-our Company’s marketed products.
• Analyzes and anticipates project 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.
• 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) System development and User Acceptance Testing (UAT) for assigned studies.
• Mentors new team members and supports staff development, as needed.
• 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.

Preferred Qualifications

• 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