Clinical Project Manager III

Werfen•Bedford, MA

21h•Hybrid

About The Position

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. Job Summary Hands-on individual contributor working as part of a large multi-function product or program development team. Provides project planning and tracking to clinical project team members and the Program Manager and/pr Clinical Research Manager. Drive the integration of activities between functions.

Requirements

Medical Technologist degree or BS in STEM is preferred
Minimum of 4 years experience in clinical project or research management
Minimum of 2 years' experience leading CRAs
Experience in design and development of medical instrumentation
Working knowledge of Good Clinical Practice (GCP) / Good Study Practice (GSP) as described by US Food and Drug Administration (FDA), World Health Organization (WHO), International Conference on Harmonization (ICH), and International Standards Organization (ISO)
Problem solving, conflict management, listening, managing and measuring work
Strong project management skill set and familiarity with project management tools and techniques
Team player, self-motivated, perseverance
Strong oral and written communication skills.

Nice To Haves

Clinical Research Associate (CRA) certification or equivalent certification in project management is desired.

Responsibilities

Provide technical and team leadership to one or more small clinical project team(s), including planning, scheduling, and technical leadership within the project area. Coordinate roles and responsibilities within the clinical project team.
Responsible for clinical project planning and scheduling, utilizing deliverable milestone methods and critical path scheduling, and developing task and project estimates. At the Program Manager's , Clinical Research managers, or Clinical Director's request provide a schedule and budget forecast for the project.
Responsible for conducting regular clinical project team status meetings and reviews. Plan and schedule technical reviews at appropriate clinical project milestones. Ensures deliverables are completed and documented according to Good Clinical Practice and per design control.
Responsible for coordination of clinical project resources to identify the root cause(s) of clinical project issues, and develop and manage a plan to fix, test, and implement an appropriate solution through completion. If needed, coordinate with cross-functional team resources to support root cause initiatives.
Responsible for insuring clinical project risks, both technical risks and management risks, are identified and appropriate risk mitigation plans are developed and executed. Track and respond to risk triggers. Regularly assess and report the status of overall clinical project risk to the development project team and Clinical Research Manager.
Creates and maintains Trial Master File(s) and corresponding Design Control files to current study ensuring accuracy.
Responsible for communication within clinical project team, development project team, and to clinical program management and department management. Develop and implement a project communication plan.
Coordinates with study sites and internal service suppliers (i.e., Biobanking, 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 identify and obtain support to resolve project team conflict. As necessary, work with development project leader to resolve cross-team conflicts. Able to remove oneself from the problem. Fosters creative, professional climate that will maximize the contributions of the multi-disciplinary clinical project team members.
Participates in activities focused on improving the efficiency and effectiveness of the product development processes and procedures.
Participates in discussions with commercial functions (operations, regulatory, distribution, customer support, marking, sales, service, affiliates, etc.) through established communication channels to support clinical project execution.
Effectively interfaces with cross-functional groups through the organization to support company goals and objectives.