Clinical Database Development Specialist - MediData / Veeva Vault

At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.

About the Role

A Day in the Life

Our Global Diabetes Capability Center in Pune is expanding to serve more people living with diabetes globally. Our state-of-the-art facility is dedicated to transforming diabetes management through innovative solutions and Technologies that reduce the burden of living with diabetes.

This position is an exciting opportunity to work with Minimed’s Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.

#BetterDaysStartNow

Responsibilities may include the following and other duties may be assigned.

• Design, develop, document, test and/ or support clinical study databases and configuration of cross-system interfaces per business process

• May support the design, development, testing, and/or maintenance of Clinical Reports, Clinical Data Transfers or other components related to clinical studies.

• Understand industry standards and apply them

• Partner as clinical technical specialists in the planning, designing, and implementing of clinical applications

• Provide technical consultation on and task direction for vendors

• Project Management tasks, such as time management, manage budget, manage milestones, communicate progress, resolve issues

• Stay current on technologies, methods, standards, and best practices as well as trends and direction of the clinical data management industry

• Review and acknowledge all Standard Operating Procedures and other quality requirements assigned to the job role

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

Specialized Knowledge Required:

Clinical database systems knowledge:

Clinical Database Development: Advanced level of proficiency with clinical electronic data capture (EDC) systems, such as Medidata Rave, and clinical trial management systems. Big-picture and detail-oriented view of development processes, tools and

procedures. Familiarity with batch upload processes, automation of uploads is preferred. Experience with custom function programming in Rave is a plus.

Clinical Reporting: Expertise with SQL and / or advanced query development tools. Experience in creating clinical operational reports and dashboards from clinical data warehouse is expected. Experience with databricks is a plus

DIFFERENTIATING FACTORS

Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.

Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.

Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.

Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with 2 years of experience.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

MiniMed offers a competitive salary and flexible benefits package

At MiniMed, we put people first. A commitment to our employees lives at the core of our values: We recognize their contributions. They share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life.

 

About MiniMed

We want to make every day a better day for people living with diabetes. Our team of creative innovators around the globe share a passion for finding the simplest solutions to the problems that people with diabetes face on a daily basis. For more than 40 years, we've been redefining what's possible, from intelligent dosing systems designed for real life to predictive insights that stay a step ahead, and we're dedicated to continuing to support our customers through every step of their journey — meeting them where and how they need it.