Director Clinical Affairs Information Management

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

This role is responsible for creating the vision, strategy and plans that guide the work of
multiple teams and effectively integrates multidisciplinary strategies to enable seamless
execution of various initiatives. The role will manage Data Management, Clinical
Systems and Biostatistics functions globally within the Clinical Affairs department. The
role balances technical expertise, strategic planning, team leadership and cross-
functional collaborations.
The data management responsibilities include overseeing data collection, management
and quality control for clinical data. Clinical systems responsibilities include overseeing
clinical technology, managing the implementation, validation and optimization of all
clinical systems in collaboration with IT department. Biostatistics responsibilities include leading design, analysis, and interpretation of data for clinical investigations while
ensuring all activities meet regulatory and scientific standards.
 

Database Management:

• Lead in lifecycle management of clinical study data collection, validation, reporting specification and usage process and guidelines.
• Oversee the development and implementation of data management plans, data collection strategies, and quality control procedures to ensure data accuracy and integrity.
• Collaborate with other teams, such as clinical operations and biostatistics, to align data management activities with overall research objectives.
• Utilize industry expertise in managing the maintenance and development of departmental operating processes (WI/DOP) for data management.
• Partner with external service providers (CROs, EDC vendors) to meet business goals.
• Proactive in understanding and assessing company needs/objectives through effective communication across multiple organizations. Works on significant and unique issues in critical situations and takes the lead in recommending solutions.

Biostatistics:

• Provide scientific and statistical expertise to drive development and life cycle management strategies. 
• Oversee the statistical design, and analyses for all phases/types of clinical investigations.
• Lead the strategy and implementation of publication-level and regulatory-level statistical programming in R, SAS, and/or Python.
• Adherence to international best practices for medical device clinical trial design, analysis, programming, and reporting.
• Develop and implement biostatistics department policies, standards, practices, and work-instructions in coordination with multiple stakeholders.

Clinical Studies Management Systems (Clinical Systems):

• Lead the implementation, management, and optimization of clinical technology solutions.
• Drive improvements in patient care and outcomes through effective use of clinical systems.
• Work with the IT department to ensure necessary corporate system support needed for clinical systems. This could include the creation of connectivity to other systems such as payments or other aspects of inventory management in the future.
• Manage system upgrades, implementation projects, and vendor relationships.
• Oversee the administration and maintenance of clinical systems at department level. This will i