Data Management Specialist, PI

Additional Location(s):  N/A

Diversity – Innovation – Caring – Global Collaboration – Winning Spirit – 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:
The Medical Data Specialist is responsible for providing expertise and oversight of data management activities for clinical studies to ensure the quality and integrity of clinical data. The Medical Data Specialist will collaborate with vendors and Boston Scientific colleagues (e.g., Clinical Project Management, Clinical Operations, Clinical IT, Biostatistics, Safety, Quality and Medical Directors).

Your responsibilities will include:

• Oversees the quality of data management and database development and ensures that worldwide processes are implemented in compliance with applicable regulations.
• Interfaces with vendors to ensure quality of their data management activities.
• Manages timelines for clinical data management deliverables in coordination with vendors and cross-functional project teams to drive data management delivery.
• Participates in the evaluation and selection of vendors and systems for outsourced clinical data management activities.
• Reviews and approves key clinical data management deliverables, including case report forms (CRFs), CRF completion guidelines, database design specifications, data entry guidelines, data management plans, edit check specifications, serious adverse event reconciliation plans, medical coding and electronic data transfer agreements.
• Provides subject matter expertise in data management related improvement initiatives, project  lifecycle, and all audits and inspections.
• Maintain compliance with corporate, core and study-specific learning requirements.

Required qualifications:

• Minimum Bachelor’s degree or appropriate equivalent
• Minimum 4 years of data management and vendor management experience in the pharmaceutical or medical device industry
• Excellent interpersonal, verbal and written communication skills

Preferred qualifications:

• Ability to work in fast-paced environment requiring support of multiple projects and customers simultaneously 
• Solid understanding of functional area and industry practices, techniques and standards
• High customer focus and ability to collaborate closely with global and cross-divisional partners 
• Skilled in organization and prioritization with a strong attention to detail
• Oncology study experience

Requisition ID: 579762

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 prohibited substance 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.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.