Clinical Data Management I

Additional Locations:  N/A

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

At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.

Hybrid Roles:

Boston Scientific's hybrid workplace includes onsite. You will have the opportunity to discuss details in the interview. 

Primary focus is providing clinical support for the Global Clinical Operations (GCO) site management team.

Support clinical studies internally & externally in start-up, enrollment, follow-up and closure of clinical trial activities.

Works under supervision with general instructions given on assignments.                                                                             

Key Responsibilities

• Source Data Review: Review/verify source data for accuracy and completeness, reviews regulatory documents. Review data collected into electronic data systems and perform basic data quality checks.
• Training: Provide training as applicable to site personnel in accordance with protocol and applicable regulations. Document and maintain site personnel list, qualification and training records per work instructions.
• Assist study team members with tasks as appropriate, (pulling reports, meeting minutes, filing, site contact emails)
• Support internal quality audits, regulatory inspections, as applicable.
• Update and maintain study-specific or project trackers as applicable.
• Compliance: Ensure any site compliance issues are addressed, clearly communicated and documented and escalated as appropriate.
• Ensure compliance with appropriate regulatory requirements (ICH/GCP, MDR, GDPR, etc.) and internal SOPs/WI, policies & procedures.
• Collaborate with cross-functional team members and study sites throughout all study phases.
• Performs quality checks on functional work, as assigned.
• Answers functional questions that may require additional research and follow-up.
• Viewed as key functional resource for a variety of tasks and projects.
• Anticipates and coordinates projects/assignments, organizes own schedule, to meet deadlines.
• May gather and prepare data in preparation of upcoming projects, meetings, provide updates as needed.
• Makes decisions using independent judgment under general guidance.
• Creates documents (letters/memos/presentations, etc.) using existing material; ensures document is logical and complete as well as accurate in grammar and spelling; makes suggestions for improvements in existing communications.
• Manages work in a confidential manner, ensuring information is shared with internal and external individuals as appropriate.
• Provides guidance to peers as necessary regarding proprietary information.

Required Qualifications:

• Bachelor’s Degree on Engineering or Health Science Carreer, or an equivalent combination of education and experience required.
• 0-2 years’ experience in clinical scientific research  
• Bilingual Proficiency preferred.

Preferred Qualifications:

• Must be comfortable interacting with clinical research site personnel via phone, video calls and email.
• Ability to work in a fact paced environment. Support several studies and/or personnel simultaneously.
• Ability to collaborate across cross-functional teams.
• Ability to work in a team environment and possess clear, concise communication & presentation skills – written and verbal

Requisition ID: 600305

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!

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.