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Senior/Clinical Research Support Specialist, Medical Affairs, APAC

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Hybrid
Onsite Location(s): 

Singapore, SG

Additional Locations: Taiwan-Taipei City; Malaysia-Kuala Lumpur

 

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance

 

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

 

Purpose statement

 

Monitor progress of clinical studies at the site level to verify that the rights and well-being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP and other applicable regulatory requirements. Provides support in startup, enrollment, follow up and closure of clinical trial activities.

 

Roles and responsibilities:

 

  • Source Verification: conducts a comparison of data recorded on Case Report Forms against source documents, verifies Informed Consent Forms for accuracy and completeness, reviews regulatory documents and device accountability records. Issue, investigate and resolve data discrepancies.
  • Communications: ensures clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos, and general correspondence.
  • Training: ensures all site personnel are appropriately trained and prepared to conduct the clinical study in accordance with protocol and applicable regulations. Monitor and maintain site personnel list, qualification and training records.
  • Site Compliance: ensures any identified non-compliance issues are addressed, clearly communicated, documented and escalated as required through monitoring visits, analyzing study metrics, and general study data overview. Support regulatory inspection activities as required.
  • Event Reporting: ensures that all reportable events are identified, clearly documented and reported per protocol and as per applicable requirements and regulations.
  • Collaboration: participates in study-specific meetings, teleconferences and trainings. Collaborates with cross-functional team members and study sites throughout all study phases.
  • Documentation: Manages study contracts, request / collection of relevant (i.e. Regulatory Docs, FDF, CV/ML) investigator / site documentation, review and approval of subset of documents in applicable database. Performs budget negotiations.

 

Role requirements:

 

  • Minimum 2-3 years of relevant experience within similar industry vertical
  • A seasoned, experienced professional with a complete understanding and wide application of principle, theories, and concepts in the field. 
  • Applies a full understanding of area of specialization to resolve a wide range of issues in creative ways. 
  • General knowledge of other related disciplines, business unit function and cross group dependencies/relationships. This job is the fully-qualified career-oriented position.
  • Develops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors.
  • Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Has a broad knowledge of a variety of alternatives and their impact on the business unit.
  • Plans and organizes non-routine tasks w/approval.
  • Initiates or maintains work schedule and priorities.
  • Plans and organizes project assignments and maintains project schedules.
  • Works under general direction regarding the direction and progress of projects and special assignments.
  • Independently determines and develops approach to solutions. 

 

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Job-specific training requirements associated with responsibilities and tasks personnel perform are established and demonstrated through their individual learning plan.

 

Requisition ID: 539198

 

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. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

 

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re 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!


Job Segment: Clinical Research, Medical Research, Compliance, Law, Healthcare, Legal, Research

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