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Clinical Data Manager II Job

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Date: Sep 11, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations:

 

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.

 

About the role:
A Clinical Data Manager II is trained in clinical data management and has demonstrated capability in building databases.  They may contribute to process improvements and initiatives within the department.  This position is within our Endoscopy division, a rapidly growing therapeutic area with great potential for advancement.


Your responsibilities will include:

  • Review study-specific Case Report Forms (CRFs) using prior device knowledge, protocol specific information and departmental standards.  Work efficiently to incorporate core clinical team input and produce queries in a timely manner as applicable. 
  • Test EDC databases based on internal procedures, approved requirements and system best practices.  Serve as project database manager for the study specific clinical team.
  • Develop database requirements for use by EDC vendors, as applicable.  Serve as project database manager and work with vendors to obtain deliverables in a timely manner. 
  • Create and update study-specific data management and database documentation, which may include:
    • Data Management Plan
    • CRF Completion Guidelines
    • Annotated CRFs
    • Database Specifications
  • Attend study-specific team meetings and produce requested metrics, which may include query information or data trends.
  • Identify improvements related to departmental processes.  As applicable, participate in development of a new process or revision of an existing process. 
  • Train internal colleagues in clinical data management in either informal or formal classroom settings as needed.
  • Train Investigators and Coordinators on the CRFs, the EDC system, and the CRF completion guidelines as needed. 
  • Provide data management expertise and support to the clinical teams using data management best practices.
  • Provides analytic insight on data management strategies and advises internal team with tactical strategies accordingly.


Required Qualifications:

  • Bachelor’s Degree 
  • 2+ years of clinical research experience
  • Minimum of 1 year clinical data management experience
  • 1+ years of Medidata Rave Architect experience
  • 2+ years of Microsoft Office experience
     

Preferred Qualifications:

  • Excellent interpersonal communication and project coordination skills with demonstrated ability to effectively interface with internal and external customers
  • Ability to prioritize and multitask
  • Excellent organization skills and attention to detail
  • Knowledge of FDA CFR Part 11 compliance and clinical study processes
  • CDISC awareness
     

 

Requisition ID: 496599

 

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!

 

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

 

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

 


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