Manager Clinical Data Management

Diegem, BE

Boston Scientific

Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world.

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Additional Locations: Belgium-Diegem; Denmark-Hellerup; France-Île-de-France; Germany-Düsseldorf; Italy-Milan; Netherlands-Kerkrade; Netherlands-Kerkrade; Netherlands-Maastricht; Poland-Warsaw; Spain-Madrid; US-MN-Arden Hills; United Kingdom-Hemel Hempstead

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: 

 

This Manager I role provides management to assigned staff members in the Clinical organization.  Through collaboration with clinical core team members, ensures clinical programs are carried out to a standard consistent with regulatory, corporate and clinical policies and procedures. This role will influence the development of policies and procedures across functions.  This role contributes to and adheres to Clinical department budget.  This incumbent develops and executes Clinical staffing plan. This role facilitates the appropriate resourcing of projects, programs, and staff training and development. You will ensure the clinical deliverables are of the highest standards. This incumbent also interfaces with other departments, Senior Clinical management, medical directors, senior functional management, and acts as BSC representative with CRO’s. 

This is a hybrid position (in the office minimum for three days per week) with the flexibility to be located in Diegem (Belgium), Arden Hills, MN (US) or other BSC locations. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist. 

 

Your responsibilities will include: 

 

  • Leads and coordinates data management activities across studies to ensure timely completion of data management deliverables (e.g., review of clinical data for completeness, accuracy, consistency, CRF/e-CRF development, database design, validation programming, and database deliverables). 

  • Responsible for managing staff based on a combination of the number of people and the type/level of direct reports and responsible for training, mentoring, development, and supervising of clinical staff in accordance with BSC policies. 

  • Offer advice and solutions to internal and external customers to address issues and enhance efficiency. 

  • Develops staffing plans for the clinical functions and makes hiring decisions and leverages/allocates appropriate resources to support the clinical organization and interfaces with Project and Trial Managers / Directors and other management to develop objectives for clinical functions and to gather performance feedback. 

  • Manages interpersonal issues and manages conflict resolutions. 

  • Ensures that best practices of study conduct are leveraged across the clinical organization and implements process efficiencies where possible and coordinates global harmonization among staff through other clinical functional line managers. 

  • Responsible for the provision of meaningful metrics to support the clinical organization and ensures staff is trained on the study specific materials, which include protocols, study tools, etc. 

  • Demonstrates thorough knowledge of and ensures staff adheres to the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable BSC SOPs and policies. 

  • Interfaces as Subject Matter Expert and acts as coach and mentor with vendors performing functional tasks. 

  • Responsible to determine, implement and execute vendor oversight activities for outsourced functional tasks. 

  • Initiate and lead initiatives that improve efficiencies of functional processes. 

 

Required qualifications:  

 

  • Minimum bachelor’s degree, or equivalent combination of experience  

  • Minimum 5 years with clinical data management experience  

  • Prior experience with EDC systems, preferably Medidata Rave  

  • Prior experience following standard operating procedures (SOP) and work instructions (WIs) in a quality environment 

  • Prior or current experience in managing data management projects   

  • Ability to travel up to 10% both domestic and international 

 

Preferred qualifications: 

  • Advanced degree in healthcare or related field preferred 

  • Demonstrated expertise in process improvement  

  • Ability to work effectively within a geographically diverse and global business  

 

 

Requisition ID: 602843

 

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!

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* Salary range is an estimate based on our AI, ML, Data Science Salary Index 💰

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Category: Leadership Jobs

Tags: Data management Research Travel

Perks/benefits: Career development Travel

Region: Europe
Country: Belgium

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