Clinical Study Specialist
4 weeks ago
About the Role:
We are seeking a highly skilled Clinical Study Specialist to join our Global Clinical Operations team at Boston Scientific Corporation. As a Clinical Study Specialist, you will play a critical role in supporting the preparation and approval of regulatory documents, ensuring compliance with service level agreements, legal and regulatory standards, and applicable company policies and procedures.
Key Responsibilities:
- Conduct clinical trial site start-up activities, including essential regulatory document collection and collaboration with Regulatory Affairs for Competent Authority submissions and approvals.
- Provide support in enrollment, follow-up, and closure of clinical trial activities, working independently and proactively to coordinate all necessary activities for site regulatory submissions and essential document collection.
- Manage multiple sets of essential regulatory documents across several studies and division portfolios, developing and fostering clinical research site relationships to become a subject matter expert in the site start-up regulatory process.
- Leverage knowledge of site regulatory processes and division priorities to meet clinical study goals and objectives, managing to achieve target IRB/EC timelines by assisting clinical research sites with the application submission process and approval tracking.
- Develop, prepare, complete, and track required regulatory, ICF, and legal documentation, documenting clinical research site and investigator readiness for participation across multiple studies.
- Support internal quality audits, regulatory inspections, as applicable, and update and maintain site-specific metrics in Clinical Trial Management Systems, file and maintain site documents in eTMFs.
- Provide updates to leadership on site start-up activities, investigator readiness, regulatory submission, approval status, etc., escalating challenges and/or initiating outreach to Principal investigators, clinical research site coordinators, divisional clinical study leads, and/or other stakeholders when appropriate.
Requirements:
- Bachelor's Degree or an equivalent combination of experience and education.
- Fluency (written and spoken) in English, a 2nd language will be a plus and highly considered.
- Must be comfortable interacting with clinical research site personnel via phone and email.
- Research Coordinator or In-House Clinical Research Associate/Clinical Research Associate/Study Start-up Specialist experience.
- Experience working with clinical trial management systems (e.g., Siebel CTMS, Veeva) and clinical document control systems/eTMF.
About Boston Scientific Corporation:
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.
Join Our Team:
We are a company that values diversity, innovation, and collaboration. If you are a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you.
-
Clinical Study Specialist
4 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Gruppe Full timeAbout the RoleWe are seeking a highly skilled Clinical Research Associate to join our Global Clinical Operations team at Boston Scientific Gruppe. As a Clinical Research Associate, you will play a critical role in supporting the preparation and approval of regulatory documents, ensuring compliance with service level agreements, legal and regulatory...
-
Clinical Study Specialist
4 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Gruppe Full timeAbout the RoleWe are seeking a highly skilled Clinical Research Associate to join our Global Clinical Operations team at Boston Scientific Gruppe. As a Clinical Research Associate, you will play a critical role in supporting the preparation and approval of regulatory documents, ensuring compliance with service level agreements, legal and regulatory...
-
Clinical Research Associate
2 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Full timeClinical Research AssociateAt Boston Scientific, we are seeking a highly skilled Clinical Research Associate to join our Global Clinical Operations team. As a key member of our team, you will play a critical role in supporting the execution of clinical trials, ensuring compliance with regulatory requirements, and fostering strong relationships with clinical...
-
Clinical Research Associate
2 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Full timeClinical Research AssociateAt Boston Scientific, we are seeking a highly skilled Clinical Research Associate to join our Global Clinical Operations team. As a key member of our team, you will play a critical role in supporting the execution of clinical trials, ensuring compliance with regulatory requirements, and fostering strong relationships with clinical...
-
Clinical Research Associate
4 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Full timeAbout this RoleWe are seeking a highly skilled Clinical Research Associate to join our team at Boston Scientific. As a Clinical Research Associate, you will play a critical role in supporting the Global Clinical Operations (GCO) Center of Excellence, conducting activities consistent with GCO's mission of building a world-class shared clinical technology,...
-
Clinical Research Associate
4 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Full timeAbout this RoleWe are seeking a highly skilled Clinical Research Associate to join our team at Boston Scientific. As a Clinical Research Associate, you will play a critical role in supporting the Global Clinical Operations (GCO) Center of Excellence, conducting activities consistent with GCO's mission of building a world-class shared clinical technology,...
-
Clinical Research Administrator
3 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Gruppe Full timeAbout the RoleWe are seeking a highly skilled Clinical Research Administrator to join our team at Boston Scientific Gruppe. As a key member of our Global Clinical Operations Center of Excellence, you will play a critical role in supporting the preparation and approval of regulatory documents, ensuring compliance with service level agreements, legal and...
-
Clinical Research Administrator
3 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Gruppe Full timeAbout the RoleWe are seeking a highly skilled Clinical Research Administrator to join our team at Boston Scientific Gruppe. As a key member of our Global Clinical Operations Center of Excellence, you will play a critical role in supporting the preparation and approval of regulatory documents, ensuring compliance with service level agreements, legal and...
-
Clinical Research Administrator
4 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Gruppe Full timeAbout the RoleWe are seeking a highly skilled Clinical Research Administrator to join our Global Clinical Operations team at Boston Scientific Gruppe. As a key member of our team, you will be responsible for conducting clinical trial site start-up activities, ensuring compliance with regulatory requirements, and providing support in enrollment, follow-up,...
-
Clinical Research Administrator
4 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Gruppe Full timeAbout the RoleWe are seeking a highly skilled Clinical Research Administrator to join our Global Clinical Operations team at Boston Scientific Gruppe. As a key member of our team, you will be responsible for conducting clinical trial site start-up activities, ensuring compliance with regulatory requirements, and providing support in enrollment, follow-up,...
-
Clinical Research Administrator
3 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Full timeAbout the RoleWe are seeking a highly skilled Clinical Research Administrator to join our Global Clinical Operations team at Boston Scientific. As a key member of our team, you will play a critical role in supporting the preparation and approval of regulatory documents, ensuring compliance with service level agreements, legal and regulatory standards, and...
-
Clinical Research Administrator
3 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Full timeAbout the RoleWe are seeking a highly skilled Clinical Research Administrator to join our Global Clinical Operations team at Boston Scientific. As a key member of our team, you will play a critical role in supporting the preparation and approval of regulatory documents, ensuring compliance with service level agreements, legal and regulatory standards, and...
-
Clinical Research Associate
4 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Full timeAbout this role:We are seeking a highly skilled Clinical Research Associate to join our team at Boston Scientific. As a Clinical Research Associate, you will play a critical role in supporting the Global Clinical Operations (GCO) Center of Excellence, conducting activities consistent with GCO's mission of building a world-class shared clinical technology,...
-
Clinical Research Associate
4 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Full timeAbout this role:We are seeking a highly skilled Clinical Research Associate to join our team at Boston Scientific. As a Clinical Research Associate, you will play a critical role in supporting the Global Clinical Operations (GCO) Center of Excellence, conducting activities consistent with GCO's mission of building a world-class shared clinical technology,...
-
Clinical Research Administrator
2 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Gruppe Full timeAbout this role:The In-House Clinical Research Associate (CRA) supports the Global Clinical Operations (GCO) Center of Excellence, conducting activities consistent with GCO's mission of building a world-class shared clinical technology, process innovation, and clinical operations team, in partnership with the company's divisions, through technology...
-
Clinical Research Administrator
2 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Gruppe Full timeAbout this role:The In-House Clinical Research Associate (CRA) supports the Global Clinical Operations (GCO) Center of Excellence, conducting activities consistent with GCO's mission of building a world-class shared clinical technology, process innovation, and clinical operations team, in partnership with the company's divisions, through technology...
-
Clinical Research Administrator
3 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Gruppe Full timeAbout the RoleWe are seeking a highly skilled Clinical Research Administrator to join our team at Boston Scientific Gruppe. As a key member of our Global Clinical Operations Center of Excellence, you will play a critical role in supporting the preparation and approval of regulatory documents, ensuring compliance with service level agreements, legal and...
-
Clinical Research Administrator
3 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Gruppe Full timeAbout the RoleWe are seeking a highly skilled Clinical Research Administrator to join our team at Boston Scientific Gruppe. As a key member of our Global Clinical Operations Center of Excellence, you will play a critical role in supporting the preparation and approval of regulatory documents, ensuring compliance with service level agreements, legal and...
-
Clinical Research Associate
2 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Full timeClinical Research AssociateAt Boston Scientific, we are seeking a highly skilled Clinical Research Associate to join our Global Clinical Operations team. As a key member of our team, you will play a critical role in supporting the execution of clinical trials, ensuring compliance with regulatory requirements, and fostering strong relationships with clinical...
-
Clinical Research Associate
2 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Full timeClinical Research AssociateAt Boston Scientific, we are seeking a highly skilled Clinical Research Associate to join our Global Clinical Operations team. As a key member of our team, you will play a critical role in supporting the execution of clinical trials, ensuring compliance with regulatory requirements, and fostering strong relationships with clinical...
