Senior Clinical Research Support Specialist Job

1 week ago

Singapore Boston Scientific Corporation Full time

**Senior Clinical Research Support Specialist Job**:
Remote Eligible: Hybrid

Onsite Locations(s):
Singapore, SG

Additional Locations: Singapore-Singapore

**Purpose and Passion - Comprehensive Benefits - Life-Work Integration - Community - Career Growth**

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

**Purpose statement**

**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
- 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.

**About us**

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

Boston Scientific is an Equal Opportunity Employer - Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran.

Boston Scientific is proud to be recognized for our innovations that impact patients' lives, our performance as a company, our workplace culture and our contributions to communities around the world. Some of our recent accolades include:

- 2021 FORTUNE World’s Most Admired Companies
- 2021 Top 100 Global Innovators by Clarivate Analytics
- 2021 Human Rights Campaign Best Places to Work for LGBTQ Equality
- 2021 Bloomberg Gender-Equality Index
- 2020 Forbes Best Employer’s for Diversi

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