Company: SIMBEC ORION GROUP LTD
Job Type: Permanent, FullTime
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 JOB
We are looking for a Business Analyst to join our Business Systems Group department. You will be based remotely in the UK.
The Business Analyst is a key position within Simbec-Orion and 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
Working alongside an experienced Business Analyst you will report to the Clinical Systems Specialist who is experienced in Business Analysis, Project Management and Project Governance.KEY ACCOUNTABILITIES
SKILLS REQUIRED Essential:
- 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.
- 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
WHY YOU SHOULD JOIN US
- 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
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. Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.