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.

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

• Participates in discussions with commercial functions (operations, regulatory, distribution, customer support, marketing, 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.

Minimum Knowledge & Experience required for the position:

• Medical Technologist degree or BS in STEM is preferred.
• Minimum of 8 years' experience in clinical project or research management
• Minimum of 4 years' managing direct reports
• Graduate-level coursework or 30-hour Certificates in project management, auditing, and/or research ethics required
• Additional course work in accounting, business economics, strategy development, resource management and/or project management is desired
• Experience In design and development of medical instrumentation is desired
• Strong knowledge of Good Clinical Practice (GCP) / Good Study Practice (GSP) as described by US Food and Drug Adminisration (FDA), World Health Organization (WHO), International Conference on Harmonization (ICH), and International Standards Organization (ISO)
• Strong knowledge of Quality System Regulation (QSR 21 CFR 820), FDA Device Regulations (21 CFR 812), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485, 14155, and 120916 standards

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

Skills & Capabilities:

• Leadership
• Functional/technical skills
• Analytical Skills
• Developing direct reports
• 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 skills

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.