Overview
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.
Responsibilities
Key Accountabilities
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. Creates and maintains Trial Master File(s) and corresponding Design Control files to current study ensuring accuracy.
7. 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.
8. 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.
9. 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.
10. Participates in activities focused on improving the efficiency and effectiveness of the product development processes and procedures.
Networking/Key Relationships
11. 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.
12. Effectively interfaces with cross-functional groups through the organization to support company goals and objectives.
Qualifications
Minimum Knowledge & Experience required for the position:
Medical Technologist degree or BS in STEM is preferred
13. Minimum of 4 years experience in clinical project or research management
14. Minimum of 2 years' experience leading CRAs
15. Experience in design and development of medical instrumentation
16. Clinical Research Associate (CRA) certification or equivalent certification in project management is desired.
17. 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)
Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement
Skills & Capabilities
18. Problem solving, conflict management, listening, managing and measuring work
19. Strong project management skill set and familiarity with project management tools and techniques,
20. Team player, self-motivated, perseverance
21. Strong oral and written communication skills.
Travel Requirements:
Up to 20% of the time (domestic and international); flexibility is required to coordinate and manage clinical site activities and collaborate with global project team members.
The annual base salary range for this role is currently $, to $,. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.
This role is eligible for medical, dental, and vision insurance, k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.
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 for assistance.
We operate directly in over 30 countries, and in more than territories through distributors. Annual revenue is approximately $2 billion and more than 7, employees around the world comprise our Werfen