Description of the Position
Clinical Development heavily relies on accurate data collected from patients who are part of Clinical Trials. Trial Standards, Trial Design, Digital Devices and Electronic Data Capture solutions are the mechanism used to ensure the right data is collected from trial participants, in the right way to enable the Clinical Research to analyze data for efficacy, dosing, safety profiling and adverse events. The data collected from Clinical Trials are used to support drug applications and regulatory submissions to health authorities globally.
Trial Data Collection & Management (TDC&M) is a core business capability that focuses on technology/process simplification and innovation to:
Improve the Clinical Trial experience for our patients
Improve efficiency of study start up by reducing the time from study initiation to first site ready
Remove obstacles and enable the Global Clinical Trial Organization to focus on what matters
As our Research & Development Division IT continues on the transition from project / portfolio-based execution to the product model, it is important to have an experienced leaders dedicated to this important capability.
We are looking for a professional with strong analytical skills and experience in the Clinical Trials domain to help us implement our vision and strategy to enable the software products within the Trial Data Collection & Management area to power the business for the next decade plus. Prior experience in IT or a degree in Computer Science is a plus.
Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation.
As a Product/Business Analyst within the Trial Data Collection and Management Product Line, you will work across our area supporting programs which enable our business partners to operate without obstacles. In addition, a significant portion of your focus will be on supporting Audits, Inspections, Due Diligence, and Regulatory Requests. In this role you will learn about how to prepare for and respond to Audits and Inspections globally. You will build expertise on system validations and will have the opportunity to learn the end-to-end clinical process.
You will work with stakeholders at all levels across our company to uncover and communicate user needs. You will be instrumental in planning, designing, and conducting testing activities, engaging support teams, and compiling critical content for training and communication to users.
You will apply a structured approach to discover, document, and manage business process and stakeholder needs. You will also gather insight into user journey, behavior, motivation, unarticulated problems, unmet needs and pain points.
You will work side by side with Business Stakeholders, Product Users, Product Managers, and Technical Leads and you will be providing close support in order to ensure that the IT solutions are both valuable and viable.
Additionally, you will:
Gather documentation related to the business process in clinical domain, document business/user needs and trace requests and responses to requests
Continuously broaden your expertise in the Clinical Trials business domain
Prepare responses and packaging documentation
Participate in creating of the process to be used for future inspections including storyboards, checklists, storage locations, etc.
Leverage business and user insights to form solutioning ideas and make prioritization decisions in order to maximize the value of the IT solutions
Work with the business to identify business value for our initiatives and determine the best way to measure that our solutions achieve the targeted business value
Build knowledge of the existing solutions through IT communities and leverage these for the benefit the business stakeholders
Travel will be required (~5 to 15%).
Qualifications, Skills & Experience
Education Minimum Requirement:
Bachelor’s degree with a preference for Engineering, Computer Science, Information Systems or a related field
Required Experience and Skills:
Minimum 3 years of experience as a Product/Business Analyst or similar role
Experience with working within a global team
Open and receptive to listening, able to ask thoughtful questions
Curious and persistent, able to discern pain points, simplify complex problems, conducting root cause analysis and identifying recommendations for improvements
Critical thinker who can effectively balance the needs of stakeholders and users, embracing new ideas/evidences to foster a collaborative atmosphere
Able to adapt to rapidly changing technology and apply it to business needs
Ability to understand business issues and needs, and easy rapport with peers and executives
Able to keep work on confidential projects within a select group and maintain confidences
Adept at managing diverse relationships across expertise, geography, and culture, regardless of organizational hierarchy
Great organization skills with the ability to manage competing priorities and coordinate activity and responses among multiple people/groups
Self-driven with the ability to work in a self-guided manner
Outstanding English (written and verbal) communication skills – able to effectively communicate complex concepts in simple ways
Desired Experience and Skills:
Prior experience in the pharmaceutical industry
Understanding of the Clinical Trials domain from the data collection and management perspective
Experience with GxP validations, System Development LifeCycle (SDLC) or working with SaaS and COTS vendors
What we offer
Exiting work in a great team
Position in leading global healthcare company
Global projects, international environment
Opportunity to learn and grow professionally within the company globally
Wide range of benefits
Flexible working hours, home office
Yearly Bonus based on company and personal performance
Pension and health insurance contributions
Edenred Benefits + meal vouchers
Internal reward system – INSPIRE – with redeeming option as services, goods or vouchers
Up to date laptop and iPhone mobile device