Siemens
Principal Clinical Research Development Specialist
Siemens, NEWTON, MA
Joinus in pioneering breakthroughs in healthcare. For everyone. Everywhere.Sustainably.
Ourinspiring and caring environment forms a global community that celebratesdiversity and individuality. We encourage you to step beyond your comfort zone,offering resources and flexibility to foster your professional and personalgrowth, all while valuing your unique contributions.
We are currently looking for an ambitious Principal Clinical Research Development Specialist to join our Endovascular Robotics business withinAdvanced Therapies. We are a global technology leader in robotic-assistedvascular interventions. We believe the combination of endovascular robotics,image guidance and dedicated devices will change the way neurovascularprocedures will be done in the future, enabling better outcomes, and enablingour customers to provide better access to care.
As a Principal Clinical Research Development Specialist,you will be responsible for:
Required skills to have for the success of this role:
Whowe are:
We are a team of more than 71,000 highly dedicatedHealthineers in more than 70 countries. As a leader in medical technology, weconstantly push the boundaries to create better outcomes and experiences forpatients, no matter where they live or what health issues they are facing. Ourportfolio is crucial for clinical decision-making and treatment pathways.
Howwe work:
When you join Siemens Healthineers, you become one ina global team of scientists, clinicians, developers, researchers,professionals, and skilled specialists, who believe in each individual'spotential to contribute with diverse ideas. We are from different backgrounds,cultures, religions, political and/or sexual orientations, and work together,to fight the world's most threatening diseases and enable access to care,united by one purpose: to pioneer breakthroughs in healthcare. For everyone.Everywhere. Sustainably. Check our Careers Site at https://jobs.siemens-healthineers.com/careers
Bewareof Job Scams
Please beware of potentially fraudulent job postingsor suspicious recruiting activity by persons that are currently posing asSiemens Healthineers recruiters/employees. These scammers may attempt tocollect your confidential personal or financial information. If you areconcerned that an offer of employment with Siemens Healthineers might be a scamor that the recruiter is not legitimate, please verify by searching for theposting on the Siemens Healthineers Career Site.
"Successfulcandidate must be able to work with controlled technology in accordance with USexport control law." "It is Siemens Healthineers' policy to comply fully andcompletely with all United States export control laws and regulations,including those implemented by the Department of Commerce through the ExportAdministration Regulations (EAR), by the Department of State through theInternational Traffic in Arms Regulations (ITAR), and by the TreasuryDepartment through the Office of Foreign Assets Control (OFAC) sanctionsregulations."
As an equal opportunity employer, we welcomeapplications from individuals with disabilities.
Wecare about your data privacy and take compliance with GDPR as well as otherdata protection legislation seriously. For this reason, we ask you not to sendus your CV or resume by email. Please create a profile within our talentcommunity and subscribe to personalized job alert that will keep you postedabout new opportunities.
Toall recruitment agencies:
SiemensHealthineers' recruitment is internally managed, with external supportpermitted only when a qualified supplier has established a formal contract withus. Unsolicited candidate submissions and referrals, absent a current supplier contract,do not establish consent and are ineligible for fees. We delete and destroyunsolicited information, thus, would recommend you refrain from any suchpractices. Your adherence to our policies is appreciated.
#LI-BM1
Equal Employment Opportunity Statement
Siemens 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.
Reasonable Accommodations
If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form by clicking on this link Accommodation for disability form If you're unable to complete the form, you can reach out to our AskHR team for support at [redacted]. Please note our AskHR representatives do not have visibility of application or interview status.
EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.
Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.
California Privacy Notice
California residents have the right to receive additional notices about their personal information. To learn more, click here.
Ourinspiring and caring environment forms a global community that celebratesdiversity and individuality. We encourage you to step beyond your comfort zone,offering resources and flexibility to foster your professional and personalgrowth, all while valuing your unique contributions.
We are currently looking for an ambitious Principal Clinical Research Development Specialist to join our Endovascular Robotics business withinAdvanced Therapies. We are a global technology leader in robotic-assistedvascular interventions. We believe the combination of endovascular robotics,image guidance and dedicated devices will change the way neurovascularprocedures will be done in the future, enabling better outcomes, and enablingour customers to provide better access to care.
As a Principal Clinical Research Development Specialist,you will be responsible for:
- Clinical study design for industry sponsored clinical trials for new products and expanded indications.
- Ensuring all clinical research activities comply with regulatory requirements (FDA, EU, ICH-GCP) and institutional policies.
- Assisting in the preparation and submission of regulatory documents, including IDE, IRB applications, informed consent forms, and safety reports.
- Addressing and resolving any data discrepancies or issues that arise during the research process.
- Developing and delivering training programs to prepare the clinical operations team to implement the study protocols.
- Staying updated on industry trends, regulatory changes, and advancements in clinical research methodologies.
- Providing leadership and mentorship to the organization, fostering a culture of excellence and compliance in clinical research.
- Additional duties and tasks as identified.
- This position may require occasional travel, estimated at 10% [domestic and/or international], depending on project needs and organizational requirements.
Required skills to have for the success of this role:
- Master's degree in a relevant field (e.g., Clinical Research, Life Sciences, Public Health), PhD strongly preferred. Relevant certifications (e.g., Clinical Research Coordinator (CRC), Clinical Research Associate (CRA)) are preferred.
- Minimum of 10 years of experience in clinical research, with at least 5 years in relevant industry sponsored trials and 5 years of strategic leadership role.
- Demonstrated experience with regulatory compliance and clinical trial management in the US and OUS.
- Experience with regulatory body (e.g., FDA) collaboration.
- Experience in regulatory submissions (e.g., IDE, De Novo)
- In-depth understanding of clinical research regulations, Good Clinical Practice (GCP), and industry standards.
- Familiarity with industry standard data management systems and research methodologies.
- Self-starter who takes the initiative with a sense of urgency.
- Excellent communication, organizational, and problem-solving abilities.
Whowe are:
We are a team of more than 71,000 highly dedicatedHealthineers in more than 70 countries. As a leader in medical technology, weconstantly push the boundaries to create better outcomes and experiences forpatients, no matter where they live or what health issues they are facing. Ourportfolio is crucial for clinical decision-making and treatment pathways.
Howwe work:
When you join Siemens Healthineers, you become one ina global team of scientists, clinicians, developers, researchers,professionals, and skilled specialists, who believe in each individual'spotential to contribute with diverse ideas. We are from different backgrounds,cultures, religions, political and/or sexual orientations, and work together,to fight the world's most threatening diseases and enable access to care,united by one purpose: to pioneer breakthroughs in healthcare. For everyone.Everywhere. Sustainably. Check our Careers Site at https://jobs.siemens-healthineers.com/careers
Bewareof Job Scams
Please beware of potentially fraudulent job postingsor suspicious recruiting activity by persons that are currently posing asSiemens Healthineers recruiters/employees. These scammers may attempt tocollect your confidential personal or financial information. If you areconcerned that an offer of employment with Siemens Healthineers might be a scamor that the recruiter is not legitimate, please verify by searching for theposting on the Siemens Healthineers Career Site.
"Successfulcandidate must be able to work with controlled technology in accordance with USexport control law." "It is Siemens Healthineers' policy to comply fully andcompletely with all United States export control laws and regulations,including those implemented by the Department of Commerce through the ExportAdministration Regulations (EAR), by the Department of State through theInternational Traffic in Arms Regulations (ITAR), and by the TreasuryDepartment through the Office of Foreign Assets Control (OFAC) sanctionsregulations."
As an equal opportunity employer, we welcomeapplications from individuals with disabilities.
Wecare about your data privacy and take compliance with GDPR as well as otherdata protection legislation seriously. For this reason, we ask you not to sendus your CV or resume by email. Please create a profile within our talentcommunity and subscribe to personalized job alert that will keep you postedabout new opportunities.
Toall recruitment agencies:
SiemensHealthineers' recruitment is internally managed, with external supportpermitted only when a qualified supplier has established a formal contract withus. Unsolicited candidate submissions and referrals, absent a current supplier contract,do not establish consent and are ineligible for fees. We delete and destroyunsolicited information, thus, would recommend you refrain from any suchpractices. Your adherence to our policies is appreciated.
#LI-BM1
Equal Employment Opportunity Statement
Siemens 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.
Reasonable Accommodations
If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form by clicking on this link Accommodation for disability form If you're unable to complete the form, you can reach out to our AskHR team for support at [redacted]. Please note our AskHR representatives do not have visibility of application or interview status.
EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.
Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.
California Privacy Notice
California residents have the right to receive additional notices about their personal information. To learn more, click here.