Clinical Research Program Manager

Siemens Healthineers

About The Position

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. This is a role well suited to an ambitious professional, looking for the next step in their career. As a Clinical Research Program Manager, you will be responsible for: In your activities you will be accountable for independently driving and overseeing Medical Evidence and Value initiatives for the assigned programs/therapy areas You will be a strategic thought partner within the assigned business unit partnering with Medical Affairs, R&D, and Marketing leads in the development of a high quality, efficient and an innovative study management program process You will independently lead all study management life cycle activities for non-registration related clinical research projects assigned for the business unit, including defining scope, deliverables, resources, and timeline You will work on complex projects (or multiple projects) spanning across business lines where analysis requires evaluation of process and procedures You will assess different operating models to incorporate new and novel approaches to planning and execution of the study management lifecycle You will collect and manage input to study protocols and operational aspects of the study. You will ensure direction of projects is in alignment with company and business unit goals and objectives. You will be accountable for establishing and monitoring high performance standards and metrics for assigned business lines You will consult and make recommendations to senior management on significant opportunities and efficiently escalates unresolvable issues when appropriate. You will actively participate and represent Clinical Research Project Management across business lines You will collaborate with cross-functional teams, such as Marketing, R&D, Legal, Compliance and Regulatory You will analyze results and interpret data from IVD clinical research studies and/or participates in preparing IVD clinical research protocols You will fully execute new policies and procedures independently You will determine key business issues, develop effective action plans and implement to successful conclusion. You will ensure study start-up activities are conducted, confirmed, and completed on-time, including preparation of IRB packages and informed consent, as required. You will have impact beyond your area of responsibility. You will interact with all levels including senior management and influence decision-making. You will operate at a strategic business level and fully incorporate business strategies within all programs. You will accompany, support, and / or lead interactions with collaborators This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers Ability to analyze results or interpret data from IVD clinical research studies and/or participation in preparing IVD clinical research protocols Ability to function in an industry standard compliant organization Ability to thrive in a changing, high-impact position, with deadline constraints Demonstrated leadership, listening, verbal and written communication skills Positive attitude and ability to develop effective relationships with all levels of organization Ability to coordinate across disciplines and integrate all aspects of business impact on projects including negotiation of scope, roles and responsibilities, requirements, timelines, and resources up, across, and down organization An understanding of statistical data analysis and statistical packages Thorough knowledge of GCP, ICH guidelines Proficient in Microsoft Office applications Must be able to work independently, be self-motivating and act as a change agent Ability to negotiate, resolve conflicts, advocate for the team at all levels Working in a Medical and Scientific Affairs organization Leadership skills and ability to motivate a team without direct line authority Risk management You have good PC skills (MS Office software like Word, PowerPoint, Excel and Outlook) You will be working with our latest technology and therefore you are willing to learn about new products, software, and hardware solutions Willingness to travel and flexibility, including short-term international deployment, is expected

Requirements

Ability to analyze results or interpret data from IVD clinical research studies and/or participation in preparing IVD clinical research protocols
Ability to function in an industry standard compliant organization
Ability to thrive in a changing, high-impact position, with deadline constraints
Demonstrated leadership, listening, verbal and written communication skills
Positive attitude and ability to develop effective relationships with all levels of organization
Ability to coordinate across disciplines and integrate all aspects of business impact on projects including negotiation of scope, roles and responsibilities, requirements, timelines, and resources up, across, and down organization
An understanding of statistical data analysis and statistical packages
Thorough knowledge of GCP, ICH guidelines
Proficient in Microsoft Office applications
Must be able to work independently, be self-motivating and act as a change agent
Ability to negotiate, resolve conflicts, advocate for the team at all levels
Working in a Medical and Scientific Affairs organization
Leadership skills and ability to motivate a team without direct line authority
Risk management
You have good PC skills (MS Office software like Word, PowerPoint, Excel and Outlook)
You will be working with our latest technology and therefore you are willing to learn about new products, software, and hardware solutions
Willingness to travel and flexibility, including short-term international deployment, is expected
Bachelor’s Degree in a scientific / technical field
Requires experience working in an IVD clinical research environment and leading multiple complex programs and project teams independently
Requires previous program management experience in multi-disciplinary setting
Minimum of 8-10 years of IVD experience
Minimum of 8-10 years of experience managing complex clinical research programs
Willing to travel up to 10%

Responsibilities

Independently driving and overseeing Medical Evidence and Value initiatives for the assigned programs/therapy areas
Strategic thought partner within the assigned business unit partnering with Medical Affairs, R&D, and Marketing leads in the development of a high quality, efficient and an innovative study management program process
Independently lead all study management life cycle activities for non-registration related clinical research projects assigned for the business unit, including defining scope, deliverables, resources, and timeline
Work on complex projects (or multiple projects) spanning across business lines where analysis requires evaluation of process and procedures
Assess different operating models to incorporate new and novel approaches to planning and execution of the study management lifecycle
Collect and manage input to study protocols and operational aspects of the study.
Ensure direction of projects is in alignment with company and business unit goals and objectives.
Accountable for establishing and monitoring high performance standards and metrics for assigned business lines
Consult and make recommendations to senior management on significant opportunities and efficiently escalates unresolvable issues when appropriate.
Actively participate and represent Clinical Research Project Management across business lines
Collaborate with cross-functional teams, such as Marketing, R&D, Legal, Compliance and Regulatory
Analyze results and interpret data from IVD clinical research studies and/or participates in preparing IVD clinical research protocols
Fully execute new policies and procedures independently
Determine key business issues, develop effective action plans and implement to successful conclusion.
Ensure study start-up activities are conducted, confirmed, and completed on-time, including preparation of IRB packages and informed consent, as required.
Impact beyond your area of responsibility.
Interact with all levels including senior management and influence decision-making.
Operate at a strategic business level and fully incorporate business strategies within all programs.
Accompany, support, and / or lead interactions with collaborators