Do you want to join us in helping to fight the world's most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.
At Siemens Healthineers, We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our global team as Clinical Monitor, in our Clinical Operations team responsible for conducting clinical monitoring activities from site identification through study close-out in accordance with GCP, ICH, SOPs and local regulations.
Our global team : We are a team of more than 68,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what's possible in healthcare to help improve people's lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.
Our culture : We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what's possible, to improve people's lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers .
This is a role well suited to an ambitious professional, looking for the next step in their career. As a Clinical Monitor , you will be responsible for :
- Independently responsible for the successful management of clinical study sites and monitoring activities for assigned clinical studies of moderate complexity projects.
- Development of the study monitoring plan and
- Performing site identification, qualification and selection, site start-up, site performance and compliance management and study close activities in accordance with Siemens Healthineers SOPs and the governing clinical monitoring plan.
- Monitors site and testing data, conducting source document verification and/or data review in accordance with the clinical monitoring plan.
- Manages site and sponsor quality records specific to monitoring activities
This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers
- Monitoring clinical trials
- Knowledge of in vitro diagnostic product design and development.
- Working knowledge of US (21 CFR 820) and EU (ISO 13485, 20916) quality system and IVD clinical performance study requirements
- The ability to work in a collaborative matrix organization with cross-functional teams is required.
- Knowledge of eClinical tools; CTMS, EDC and eTMF
- Ability to quickly learn different project modalities (i.e, assay types, instrument functionality) to effectively perform essential job functions
- Corrective and Preventative concepts in managing clinical site performance
- Excellent interpersonal, communication and presentation skills, in person and virtually.
- Astute attention to detail, effective planning and organizational skills and the ability to critically process/coalesce information and draw conclusions from multiple sources.
- Attention to quality in all initiatives
Required skills to have for the success of this role - Bachelor's degree in Life Sciences or related field
- 3-5 years Clinical Monitoring experience
- Industry Certification (ACRP or SoCRA) preferred
- Clinical Monitoring experience with Medical Device and/or IVD preferred
- Experience with risk-based monitoring preferred
- Medical or Clinical laboratory experience preferred
- Ability to travel to clinical sites at a 30-50% travel rate.
The pay range for this position is $93,000 - $138,000 annually [ however, base pay offered may vary depending on job-related knowledge, skills, and experience. The annual incentive target is (8%) of base pay. Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay. Details regarding our benefits can be found here
: https://benefitsatshs.com/index.html This information is provided per the required state Equal Pay Act. Base pay information is based on market location. Applicants should apply via Siemens Healthineers external or internal careers site.
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
If you want to join us in transforming the way healthcare is delivered, visit our career site at https://jobs.siemens-healthineers.com/careers If you wish to find out more about the specific division before applying, please visit: https://usa.healthcare.siemens.com/about .
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As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.
Equal Employment Opportunity StatementSiemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.
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