The Study Manager will have responsibility to manage clinical research studies within the Medical Affairs – Medical Sciences and Scientific Affairs organization, working closely with key Medical Affairs stakeholders. These projects are focused on driving evidence generation towards Medical Affairs activities, collaborations, streamlining and standardizing processes, and enhancing partnerships with external key thought leaders and Laboratory Diagnostics functional team stakeholders. As study manager working across multiple projects, he or she will work closely with team members and stakeholders across sites and functions within and outside of Siemens Healthineers to plan, schedule, prioritize, track, and execute to ensure clinical research project objectives and timelines are achieved compliantly.
- Facilitate project prioritization activities.
- Define scope, deliverables, resources, and timeline of each project.
- Develop and drive project plans.
- Collect and manage input to study protocols and operational aspects of the study.
- Ensures study start-up activities are conducted, confirmed, and completed on-time, including preparation of IRB packages and informed consent, as required.
- Clinical research study (Investigator Initiated, Collaborative Research, Siemens Healthineers Sponsored) monitoring.
- Establish business cases as needed, aligning project targets with business goals.
- Conduct proactive project risk assessments.
- Assess budget and resources necessary to be successful.
- Ensure cross-functional collaboration and cooperation.
- Implement necessary contingency and mitigation plans.
- Communicate effectively to key stakeholders.
- Escalate issues in a timely manner to assure expedited resolution.
- Assure compliance to standards, laws and regulations.
- Serve as main contact for quality/compliance issues, escalating as necessary.
- Ensure appropriate project documentation, including development of plans, processes, or procedures, where needed.
- Contribute to SOP development.
Required Knowledge/Skills, Education, and Experience
- Bachelor’s Degree in a scientific / technical field
- Experience working in a clinical research environment
- 8-10 years of experience managing complex studies
- Ability to function 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
- A general 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
Preferred Knowledge/Skills, Education, and Experience
- Ability to negotiate, resolve conflicts, advocate for the team at all levels of the organization
- Experience working with a Medical Affairs organization
- Leadership skills and ability to motivate a team without direct line authority
- Risk management
- IVD experience
Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity. Going forward, please be aware that Siemens Healthineers requires full COVID-19 vaccination for all new hires by their start date except where prohibited by state law.
(Note: Accommodations may be requested for certain medical or religious reasons)
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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