Senior Clinical Program Manager

Job Information

Number

ICIMS-2025-9146

Job function

R&D

Job type

Full-time

Location

Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States

Country

United States

Shift

1st

About the Position

Introduction

Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Overview

Job Summary

Hands-on contributor providing technical and team leadership to a multi-functional clinical development project and / or several small multi-functional clinical projects simultaneously. Drive the integration of activities between functions and across programs, and the successful attainment of program goals. May provide reporting to department and business leadership.

Responsibilities

Key Accountabilities

• Provide technical and team leadership to one or more large clinical project team(s) or clinical program team(s). This may include directly lead Ing one of the projects. Leadership entails planning, scheduling, assignment of work, and technical support within the program area.
• Responsible for clinical project or program planning and scheduling, clarifying and defining scope of work, utilizing deliverable milestone methods and critical path scheduling, conducting resource planning and allocation, and developing task and project estimates. Generates an Integrated project plan that meets business objectives and are in compliance with the design control process and good clinical / study practices, and aligned with clinical research industry best practices while maximizing resource efficiency.
• Responsible for conducting regular clinical project or program team status meetings and reviews. Ensures deliverables are completed and documented. Identifies the need for and implements changes to the clinical program and project plans that are within approved program and project boundaries. Plan and conduct major clinical program and supporting project and milestone reviews.
• Responsible for ensuring clinical program and project risks both technical risks and management risks are identified, and appropriate risk mitigation plans are included within the clinical program plan and associated development project plan. Regularly assess and report the status of overall clinical program risk remaining on a program. Identify risk trends and patterns across the clinical program and develop risk mitigation strategies for systemic risks.
• Responsible for coordination of clinical program and project resources to identify the root cause(s) of clinical program and project issues, and together with the development project manager, co-develop and co-manage a plan to fix, test, and implement an appropriate solution through completion.
• Creates and maintains file to current phase ensuring accuracy. Ensure compliance with Design Control practices and Good Clinical Practice Trial Master File standards.
• Responsible for program communication for both within the clinical project team(s) and between the clinical and development project team(s) and executive management. Uses input from regulatory affairs, medical office, and commercial functions to influence and execute program plan.
• Responsible for ensuring adequate oversight and control of vendors providing services that directly support clinical projects, such as EDC, IRB, CRO, or single-function services. Support Clinical Project Managers In coordinating with study sites and internal service suppliers (i.e., Blobanking, Field Service Engineers, etc.) to ensure project deliverables are completed correctly and on time or that services are provided in accordance with the project plan.
• Able to resolve program and project team conflict through the application of good listening skills and negotiating skills. Able to remove oneself from the problem. Fosters creative, professional climate that will maximize the contributions of the technical staff.
• Demonstrated functional management expertise and skills in developing, mentoring and coaching others. Works with functional management participating In skills / gap assessments and conducting coaching for project core team members. Provides indirect supervision to Program Managers and Project Managers assigned to the program.
• Lead activities focused on improving the efficiency and effectiveness of the product development processes and procedures.

Networking / Key relationships

Qualifications

Minimum Knowledge & Experience required for the position :

Management has the discretion of substituting relevant work experience for a degree and / or making exceptions to the years of experience requirement.

Skills & Capabilities :

Travel requirements :

Up to 15% of the time (domestic and international); flexibility is required to coordinate and manage clinical site activities and collaborate with global project team members.

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity / expression, national origin / ancestry, age, mental / physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com

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