ABOUT US

Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team.

With a focus on tailormade and scalable solutions, we’ll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives.

THE ROLE

We are looking for a Business Analyst to join our Business Systems Group team where you will operate with a pre-defined business area of Simbec-Orion to work with our business and clinical users to drive Business Transformation through:

• Understanding the key business deliverables and what dependencies exist with other departments and defined the key inputs and outputs.
  • Identifying opportunities for process improvement and understanding and prioritising which processes will drive/improve productivity
  • Identifying and documenting improvement requirements and managing the pre-project process
  • Selecting and Implementing solutions (solutions comprising technology, data, processes and people) and being involved in the Change Management associated with business
• Youwill be working alongside an experienced Business Analyst and you will report to the Clinical Systems Specialist who is experienced in Business Analysis, Project Management and Project Governance.

KEY ACCOUNTABILITIES

• Development of To-Be Process maps
• Development of project plans to deliver improvements to Business and Clinical teams (i.e. Business Transformation)
• Analysis of Business/Clinical requirements, via Workshop Requirement Gatherings, resulting in Requirements Specifications Catalogue and Project Documentation
• Managing the Procurement process if a new system is required
• Ensuring Solutions (comprising technology, processes, people and data) work to deliver data security, accuracy, completeness, validity, timeliness and reliability
• Being involved in the Change Management associated with a Project, including Training, Role Definitions, Communications etc.
• Ability to work with and co-ordinate with multiple vendors.
• Create and execute Installation Qualification (IQ), Operation Qualification (OQ), Performance qualification (PQ) documents for GxP applications.
• Collaborate with quality team to develop project validation documentation and test plans.
• Ability to execute protocols, perform testing sequences and change controls.
• Administer enterprise applications and maintain (patch), repair and manage new and existing systems in a regulated environment.
• Attend or provide support to external Sponsor/Regulatory Audits and manage any Audit responses
• Provide day to day and scheduled application support; respond to application support issues from multiple business customers.
• Ability to provide communications, both written and verbal, to the wider teams.

SKILLS REQUIRED

Essential

• Bachelors degree in a subject that demonstrates “logical” and “analytical” thinking
• Previous experience working as a business analyst
• Previous experience of Computer System Validation
• Strong communication and interpersonal skills
• Able to create documentation for a variety of audiences

Desirable

• Previous experience of managing a project from inception to operation
• Previous experience of working within a Business Analyst Role within a Clinical Research Organisation or Pharmaceutical Company

WHY YOU SHOULD JOIN US

Simbec-Orion is growing fast. To keep up with demand, we’re looking for the best people, from all areas of clinical development, to join our team.

We’re dedicated to bringing the latest advances in science to market. Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company - and your reason to be a part of it.

With experts from all disciplines under the same roof, you’ll work alongside some of the industry’s best. So if you’d like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services. We’re waiting to hear from you. our clinical pharmacology site, or laboratory services. We’re waiting to hear from you.