Associate Director, Clinical Data Management
Diegem, BE
About this role:
This global role is responsible for managing a substantial part of the Clinical Data Management team within the Global Clinical Operations (GCO) department. With the recent centralization of Clinical Data Management into a Center of Excellence, this role will be pivotal in shaping the future of data management across divisions by fostering greater collaboration and alignment. This is a unique opportunity to make an impact across all BSC Clinical divisions and regions.
By collaborating with clinical core team members, this role ensures that Clinical Data Management activities are executed consistently and in compliance with regulatory, corporate, and clinical policies and procedures. The incumbent will also play a key role in shaping new process improvements and will influence strategic discussions related to new technologies.
This role will contribute to and adhere to the Clinical department budget, facilitate the appropriate functional resourcing of projects and programs, and ensure staff training and development. The incumbent will also be responsible for defining and providing meaningful functional metrics to support the clinical organization.
This role will interface with other departments, senior Clinical management, medical directors, senior functional management, and may act as the BSC representative with CROs or vendors.
This role requires hybrid presence (three times per week) at an assigned BSC office location.
The position can be based in any EMEA BSC office.
Your responsibilities will include:
- Leads an area within the Clinical Data Management function directly and through M3s/M4s. 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.
- Develops staffing plans for the clinical function and makes hiring decisions and leverages/allocates appropriate resources to support the clinical organization and interfaces with Project and Program 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 provides guidance to foster global alignment among staff, directly or through other 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.
- Responsible to determine, implement and execute vendor oversight activities for outsourced functional tasks.
- May lead initiatives that improve efficiencies of functional processes.
- Applies knowledge of business and industry drivers and the factors that maximize performance of area(s)managed; interprets and monitors business trends and market developments to contribute to plans to address business challenges
- Identifies and resolves complex functional technical, operational and organizational problems
- Applies professional expertise to recommend solutions and preemptively solves problems with considerations for potential broader impact and applicability to the area, with guidance only in the most complex situations
- Develops implementation strategies for developed solutions
- Makes decisions that impact the business results of area –including the support, prioritization, and funding of projects, products, services and/or technologies
- Influences the opinions and decision making of others internally or with external partners/vendor/customers to achieve department objectives; persuades peers and higher level managers (e.g. M6s-M7s) and builds consensus to take action/ adopt recommendations
- Leads briefings and technical meetings for internal and external stakeholders concerning specific projects, operations or schedules; converts technical information to compelling business context and advice
Required qualifications:
- Minimum Master’s degree in any healthcare or related scientific field
- A minimum of 10 years of experience in clinical/scientific research and medical device experience
- A minimum of 5 years leadership experience managing global teams
- Prior experience working with Clinical Data Collection systems
- Prior experience following standard operating procedures (SOP) and work instructions (WIs) in a quality environment
- Strong experience/expertise in Clinical Data Management
- Up to 15% travel may be required
Preferred qualifications:
- Demonstrated expertise in leading and implementing effective change management strategies in dynamic environments
- Demonstrated success in building and managing global teams, mentoring, and developing team members
- Demonstrated expertise in process improvement and project management
- Strong collaboration skills including the ability to build relationships with key stakeholders
- Exceptional communication skills, both written and verbal; strong listener
- Highly organized with the ability to prioritize and work in a very fast-paced environment
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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