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We are currently looking for a Clinical IS Senior Analyst to join a leading company based in the Cambridge area. As the Clinical IS Senior Analyst you will be a business partner to the Clinical Development groups. Focused on gaining an in depth understanding of business partner processes across Clinical, Quality, Pharmacovigilance, Regulatory, Data Management and related functions; they create strong collaborative relationships and take a leading role in the selection, design, implementation, validation, delivery and adoption of new information systems.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Clinical IS Senior Analyst will be varied however the key duties and responsibilities are as follows:
- Develops close working relationships with the Clinical Development teams through effective project engagement and consistent delivery of business expectations. - Delivers high-value systems aligned with business requirements, collaborating closely during system selection, design, implementation, validation, and rollout to production. - Works closely with business partners and stakeholders to ensure systems meet regulatory requirements utilising a risk-based approach to system validation. - Supports effective adoption of new systems by working closely with business partners to create high-quality training materials and user support. - Gains a detailed knowledge of Clinical Development business processes through shadowing, process review, and collaboration.
To be successful in your application to this exciting opportunity as the Clinical IS Senior Analyst we are looking to identify the following on your profile and past history:
- Demonstrable experience overseeing the planning, delivery and maintenance of a portfolio of business critical computerised solutions on time and on budget. - Working knowledge of the system design lifecycle, IT project management and development of validation/qualification documentation within a regulated environment. - Interfacing and collaborating with both technical and non-technical colleagues including IT contractors/developers, business stakeholders and customers, vendors/suppliers, at all levels including senior management and board level. - Strong decision making skills, able to develop positive coaching/mentoring relationships with matrixed team members. - Excellent analytical and problem solving skills. Able to understand and absorb complex information and requirements. - Excellent organisational skills, meticulous and methodical. Good at prioritising and flexible enough to adapt plans. Comfortable working to tight deadlines and within constraints. - Excellent written and verbal communication skills, strong presentation skills, and able to communicate complex information in simple terms. - Ability to develop pragmatic, innovative approaches to the adoption of technology/IS solutions within strict regulatory constraints. - Forms trusting, collaborative and strategic relationships with internal stakeholders and external partners with skills in assertion, negotiation, influencing, tact and diplomacy. - Can instil a culture of considered change management for his or her deliverables in order to drive effective adoption and maximise the customer experience. - Has a Service' mentality, recognising and promoting the enabling value that technology can provide to customers.
Key Words: Clinical, Quality, Pharmacovigilance, Regulatory, Data Management, system selection, design, implementation, validation, analytical