Senior Specialist - Clinical Supply Project Manager - Protocol – Hybrid
About The Position
The Global Clinical Supply organization manages the end-to-end integrated clinical supply chain across the company’s clinical trial portfolio, including planning, sourcing, labeling, packaging, and delivery of clinical supplies to sites globally. The GCS Planning organization serves as a key interface between clinical development teams and the operational groups responsible for execution. Working independently, the Protocol Clinical Supplies Project Manager designs strategic and operational plans for clinical supply activities for assigned studies, which may vary in complexity. The role is the primary GCS contact for internal and external stakeholders and represents GCS at clinical development and product development meetings. It requires understanding the end-to-end product development process and the connections among clinical development, CMC, supply chain, and human health, while balancing patient needs and stable product supply. The position also contributes to supply-chain metrics, system and process improvement, compliance activities, regulatory inspections, and documentation supporting clinical supply, labeling, packaging, and CMC work. The role calls for sound risk decisions, strategic and tactical execution, ownership, accountability, and a focus on customers and patients.
Requirements
- Bachelor’s degree in a scientific, business, or related discipline.
- At least 5 years of project management experience.
- At least 5 years of experience in planning, scheduling, coordinating, and processing supply-chain activities, or equivalent experience.
- Excellent communication and interpersonal skills, including the ability to communicate with cross-functional stakeholders, senior management, external vendors, and clinical sites.
- Strong negotiation, influencing, and relationship-building skills.
- Strong knowledge of project management principles and clinical customer relationship management.
- Familiarity with supply-chain systems and software, such as SAP or Oracle, demand-planning principles, and Microsoft Excel, PowerPoint, and Word.
- Strong analytical and problem-solving skills, including analyzing complex data, identifying trends, and making data-driven decisions.
- Ability to adapt to a fast-paced, dynamic environment and changing business needs and priorities.
- Strong attention to detail and organizational skills, including the ability to multitask, prioritize, and meet tight deadlines.
- Proactive continuous-improvement approach, including identifying process inefficiencies, developing solutions, and driving improvement initiatives.
- Proficiency with supply-chain management systems, including ERP systems, demand-planning tools, and inventory-management systems.
- Proven record in project or portfolio management.
Nice To Haves
- Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).
- Ability to execute collaborative projects and develop subject matter expertise.
- Knowledge of order management, supply-chain operations, and document control.
Responsibilities
- Participate as a key stakeholder on Clinical Trial Teams and collaborate with functional representatives to negotiate clinical supply timelines and strategy.
- Work with clinical development, regulatory, quality, and other supply-chain partners on clinical supply and change-management topics.
- Establish timelines for study clinical supply needs and signal sourcing, manufacturing, packaging, and distribution requirements for development and non-marketed products.
- Analyze and anticipate clinical supply-chain risks and develop mitigation strategies for review with clinical partners and senior leaders.
- Use IRT, Microsoft PowerApps, SWMS, Veeva, MEDS, MyLearning, and other Microsoft applications to manage clinical supplies for assigned studies.
- Use SAP to establish a consolidated and visible forecast of study product needs, including bulk drug product and clinical finished goods.
- Author clinical supply documentation supporting labeling and packaging activities and supply-chain documentation supporting critical CMC activities.
- Author the Clinical Supplies section of study protocols and prepare and present clinical supply information at Investigator Meetings for assigned protocols.
- Support collection of clinical supply-chain metrics and participate in critical non-pipeline activities.
- Participate in IVR system development and User Acceptance Testing for assigned studies.
- Initiate and process change controls in a timely manner in collaboration with GCS Planning and cross-functional stakeholders, following applicable procedures and work instructions.
- Author and process deviation records and support deviation investigations as needed.
- Contribute to non-pipeline and compliance activities, including process improvement, subject matter expert work, SOP/BP development and maintenance, and cross-functional projects.
- Support regulatory agency inspections for assigned trials as required.
- Solve unstructured problems, make informed decisions about technical and business risks, and influence portfolio decisions using facts and data.
- Balance strategic planning with tactical execution and maintain ownership and accountability for assigned work.
Benefits
- Medical, dental, and vision healthcare benefits.
- Other insurance benefits for employees and family.
- Retirement benefits, including a 401(k).
- Paid holidays, vacation, compassionate days, and sick days.
- Eligible for an annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
