Senior Specialist - Clinical Supply Project Manager - Protocol - Hybrid

Merck & Co.

West Point (PA)

Hybrid

USD 117,000 - 184,000

Full time

3 days ago

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Job summary

Merck & Co. seeks a Protocol Clinical Supplies Project Manager to design strategic and operational plans for clinical supplies across assigned studies.

You will serve as the primary GCS contact for internal and external stakeholders and drive end-to-end supply planning aligned with GMP/GCP expectations. The role requires strong experience in project management, supply chain coordination, and familiarity with SAP, IRT, and related systems.

Qualifications

Bachelor's degree in scientific, business, or related discipline.
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.
Proficiency with SAP or Oracle and Microsoft Office applications.

Responsibilities

Participates as a key stakeholder on the Clinical Trial Teams (CTT) and collaborates with cross-functional partners to plan timelines and strategy for clinical supplies.
Interacts with clinical development, regulatory, quality and other supply chain areas to address topics related to clinical supply and change management.
Establishes timelines for study-specific clinical-supply needs and coordinates sourcing, manufacturing, packaging, and distribution.
Analyzes study risks related to the clinical supply chain and develops mitigation plans for review with partners and senior leaders.
Utilizes tools such as IRT, PowerApps, SWMS, Veeva, MEDS, MyLearning, and MS Office in management of assigned studies.
Works in SAP to create a consolidated forecast for study product needs (Bulk Drug Product and Clinical Finished Goods).
Authors clinical supply documentation for labeling, packaging, and CMC-related activities.
Prepares and presents the clinical supplies section of study protocols and supports Investigator Meetings.
Collects supply chain metrics and participates in non-pipeline and compliance activities as needed.
Participates in IVR system development and user acceptance testing for assigned studies.
Supports change controls, deviation records, investigations, and regulatory inspections as required.

Skills

Analytical Thinking

Clinical Supplies Management

Clinical Supply Chain Management

Clinical Trial Management

Data Analysis

MRP

Project Management

Stakeholder Management

Strategic Planning

Supply Chain

Education

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

Tools

SAP

Oracle

Microsoft Excel

PowerPoint

Word

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 product-development 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 clinical-supply-needs-per study and providing-the 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) System-development 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.

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 Chain

Preferred Skills:

Communication
Decision Making

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.

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

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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.

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 https://jobs.merck.com/us/en/compensation-and-benefits .

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

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Shift

1st - Day

Valid Driving License