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Last updated: 11:39 22/02/2013

Business Analyst

Reference number: 1999 Apply for this job Apply for this job »
Type: Permanent, full time Location: West Sussex, Office based

Job Description

Summary:

 Business Analysts are responsible for engaging with product owners, elaborating requirements and presenting these to the engineering and test teams.  As the engineering and test groups work in an Agile manner, the Business Analysts may also carry out Retrospectives (understanding of the successes and possible shortcomings of earlier sprints).  Other responsibilities will include proactive involvement in evolution of processes, both relating to the Business Analysis as well as assisting broader process needs.

 

 

The Role:

 

·         Express and present requirements provided by product owners to Programming and Test teams

·         Present precise and accurate descriptions of customer requirements

·         Engage in productive collaboration with internal and external customers

·         Take active position in describing and advancing processes relating to Business Analysis activities

·         Lead, support, create and follow SOPs and other internal processes

·         Support and provide guidance to teams working in an agile framework

·         Perform Retrospectives (post-sprint analysis) for internal teams as required

·         Work with UX Designers and Information Architects to assist in the production of mock-ups and wireframes for UI development

·         Continual updates to domain knowledge for areas covered by the company’s software platform and any associated company products/developments

·         Provide accurate and timely reporting to the Head of Section

Experience/Qualifications required

Skills and Attributes:

 Demonstrated ability to express requirements from product owners to engineering and test teams

  • Easy working manner supporting productive collaboration with internal and external customers
  • Excellent presentation, coaching and facilitation skills. Ability and enthusiasm for delivering training solutions
  • A strong customer service orientation with an excellent telephone manner
  • Excellent organisational skills
  • Excellent interpersonal and communication skills, and the ability to operate effectively in a global working environment
  • Ability to listen and interpret technical actions in a non-technical manner
  • Work calmly under pressure and meet deadlines
  • Professional, positive, dynamic and driven
  • A good understanding  of clinical terminology
  • Ability to prioritise activities in line with client business needs
  • A good investigative and meticulous approach to all activities and tasks
  • Team player
  • The ability to work effectively and efficiently with internal partners within the company

 Experience:

 Proven experience of presenting precise and accurate descriptions of requirements

  • Working experience within an Agile environment
  • Experience working with a Pharmaceutical company, or organisation operating in a regulated environment
  • Experience working within a software development group, including collaboration with User Experience designers and Information Architects
  • Experience working with the Atlassian Confluence application
  • Experience working with Jama Contour requirements management application

 Note : The last 4 of the experience requirements are preferred only and not essential.

 Qualifications:

 Degree educated - postgraduate experience would be beneficial

Senior Safety Systems Analyst

Reference number: 1993 Apply for this job Apply for this job »
Type: Contract, fixed term Location: Office based in Welwyn Garden City, UK

Job Description

The Role:

*  Provides leadership to the PVIS team in conjunction with the PV Information and Systems Manager

* Deputises for the PV Information and Systems Manager as appropriate

*  Analyses and solves a wide range of complex process and system related problems in all areas of PVIS’s responsibility

*  Develops and/or performs custom database searches and outputs through tools like SQL, Business Objects or SAS, to support PVIS processes

*  Works with the safety systems user community to define requirements for standard reports, and implements, tests and documents these reports

*  Provides change management, master data maintenance and front-line application support for applicable Drug Safety systems on behalf of PDS

*  Performs global safety database activities, global regulatory submission activities, basic safety data searches and reporting

*  Content management using information management tools like DSO and QTT

* Assesses, evaluates and implements technology enhancements to support global and local business processes

* Interacts with Drug Safety functional groups, other information management functions in Development, IT organisations, external business partners, vendors and health authorities

*  Represents the PVIS group in department and cross-functional initiatives

*  Creates or reviews requirements, specifications and business process documentation

*  Designs logical and innovative solutions to complex problems

*  Participates in global, cross-functional activities and projects, i.e. within PDS, as well as affiliates and other PD functions

* Provides support, administration and change management for existing Drug Safety systems

*  Maintenance of the systems’ Master Data (i.e. business configuration) such as user account management, regulatory reporting rules, document templates, protocols, drug dictionaries

*  Acts as a process owner for Master Data activities and works closely with the management team to ensure that the process remains effective and works efficiently

*  Ongoing review of PV Information and Systems processes to provide suggestions for continuous improvement

 

*  Prepares, delivers and maintains training overview of all new starters as part of Global PDS Induction Programme

 

*  Prepares and delivers training to Global PDS required for the implementation of any process or system change

 

*  Provides support and mentoring to other PV Information and Systems Group members

 

*  Performs and documents user acceptance testing on submission rules and associated processes

 

*  Ability to interpret business and regulatory reporting requirements to enable system users to comply with current guidelines and plan for future changes

 

*  Works closely with Informatics colleagues (FIGL) to identify and implement technology solutions to meet business requirements

 

*  May be required to travel        

 

The statements made in this job description are intended to describe the general nature and level of work being performed by those persons assigned to this job.  These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job.

 

Experience/Qualifications required

Skills and Attributes:

 *  Drug Safety knowledge or other relevant experience in the drug development environment within the pharmaceutical industry

*  Strong technical knowledge in database technologies, and query and reporting tools, such as SQL, Business Objects and SAS

*  Thorough knowledge of the application of software solutions to complex business problems in a validated environment

*  Excellent communication skills to analyse problems and discuss solutions with colleagues, project team members and users

*  Extensive prior experience with analysis and reporting of drug safety and/or clinical trial data

*  Knowledge of drug safety regulatory obligations and guidelines

*  Working knowledge of medical terminologies, e.g. MedDRA

*  Working knowledge of industry standard safety systems

*  Computer literacy

*  Fluent in English

* Able to work independently and to act with a minimum of supervision

*  Generates enthusiasm and drive for commitment to excellence

*  Able to design innovative solutions

*  Displays a high level of commitment

*  Works well in a team environment

*  Proven good communication skills

*  Can deliver informative, well-organized presentations to team and management

*  Good attention to detail

*  Confident decision maker

*  Demonstrates analytical and problem solving skills

*  Good time management and organisational skills

*  Structured/ methodical approach to work

 

Qualifications and Experience:

 

*  Life Science/ Computer Science qualification or other relevant career experience

Senior Technical Analyst

Reference number: 1943 Apply for this job Apply for this job »
Type: Permanent, full time Location: Sheffield or Berlin

Job Description

Summary:

 Provide technical expertise as well as conduct specification development and functional testing.

General areas of responsibility include: specification creation, clinical database testing and development of the specifications for data consistency checks programming, test data creation and functional testing, import/export programming functional testing and specification development, as well as mapping specifications to support relevant data standards. All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.

 The Role:

 Relationships

Reports To Associate Manager or above

Directly Supervises N/A

Provides Work Direction to Technical Analysts, Clinical Database Programmer(s) as appropriate

Works Closely with Line Managers, Clinical Database Programmers, Technical Analysts,

Quality Management Group (QMG), Project Team Members, Data Operations Leader, Clinical Data Analysts (CDAs), Information Services (IT), Biostatisticians, Technical Integration Architects (TIAs), Statistical Programmers and other GRO project members

External Relationships

Sponsors, External Vendors

Experience/Qualifications required

Skills:

 • Influencing and negotiation skills including working in a global team environment

• Strong customer focus with a service mentality.

• Ability to manage multiple and varied tasks with a high quality standard.

• Attention to detail and strong organisational skills.

• Ability to work independently and prioritise a diverse workload.

• Very good understanding of System Life Cycle process and applicable regulations pertaining to Computer Systems (e.g. ICH-GCP, 21 CFR 11).

• Relevant experience in maintaining and supporting of processes in a distributed client base within a regulated environment.

• Proficiency in a programming environment and understanding of relational databases.

• Very good understanding of IT and the departments within GRO.

• Excellent analytical skills and attention to details

• Dedicated skills such as clinical development process and related data standards.

 Language Skills

• Excellent English written and oral communication skills

 Experience:

 • Relevant work experience required

 Qualifications:

 • B.C.A./M.C.A./M.Sc./B.S./B.Sc./B.A. in a science or industry-related discipline

Technical Analyst

Reference number: 1942 Apply for this job Apply for this job »
Type: Permanent, full time Location: Sheffield or Berlin

Job Description

The Role:

 General

  • Write specifications and perform functional testing of electronic as well as paper clinical databases and validation programming
  • Develop and maintain a good understanding and working knowledge of department-specific technologies, as well as other relevant systems
  • Design, specify and review Case Report Forms (CRFs, eCRFs), and incorporate feedback
  • Translate protocols into requirements for the clinical database and develop corresponding specifications for database programming, and data load/export
  • Provide input into other Programming Group activities as required
  • Work closely with the Quality Process and the Training Learning Group to ensure compliance with SOPs/Work Instructions/Guidelines, ICH-GCP and any other applicable local and international regulations

 Quality Checks and Testing

  • Create test scripts and test data for all the CDMS and EDC technologies
  • Generate test data for all QC of programs
  • Develop specifications and test plans and scripts to support the functional testing of systems
  • Set up, test and approve existing relevant tools, as well as ensure that this has been documented in the standard QC checklist and that the process is compliant to the tool utilised.
  • Participate in internal/external audits and regulatory inspections as required.

Perform quality control on all technical activities related to trial set-up and processing

 Documentation

  • Provide technical guidance to other team members
  • Create and maintain Clinical Database Documentation

 

Programming and Systems and Data Standards

  • Implement applicable standards for clinical database specifications
  • Develop mapping specifications for data exports in accordance with applicable standards
  • Understand the architecture of a system, as well as the impact of database/program changes and what touch points are required to be re-tested

 

Experience/Qualifications required

Skills:

 Proficiency in a programming environment and understanding of relational databases

  • Excellent English written and oral communication skills
  • Influencing and negotiation skills including working in a global team environment
  • Strong customer focus with a service mentality
  • Ability to manage multiple and varied tasks with a high quality standard
  • Attention to detail and strong organisational skills
  • Ability to work independently and prioritise a diverse workload
  • Very good understanding of System Life Cycle process and applicable regulations pertaining to Computer Systems (e.g. ICH-GCP, 21 CFR 11)
  • Excellent analytical skills and attention to details
  • Dedicated skills such as clinical development process and related data standards

 Experience:

 Exposure to at least one programming environment (e.g., SAS, CDMS, EDC, SQL, VB, Java)

 Qualifications:

 Bachelors or Masters degree in a science or industry-related discipline

 

NET Web Developer

Reference number: 1918 Apply for this job Apply for this job »
Type: Permanent, full time Location: London

Job Description

The Opportunity

 To join a well established business that is recognised as the leader in EDC and Data Management solutions in Early Phase Clinical Trials.  The Life Science and Pharmaceutical Industries represent rapidly expanding markets, where the potential for technologically lead solutions are still enormous, especially given that the clinical trial environment was relatively slow in adopting and utilising such technologies and still rely very heavily of paper based solutions.

 Within Logos you will be given the freedom and autonomy to be their .NET expert and take the lead in developing the company’s new interface for their ALPHADAS web-based portal.  This is critical to the vision of this Software business and as such you work closely with, and report directly into, Logos’ Managing Director, Giles Wilson.

 Job Purpose and Responsibilities

 ·                                       To become Logos’ expert and lead in .NET development processes.

 ·               Working from a completely blank canvas, you will act as front-end developer, using Windows.NET 3.5 to design a fully functional, visually pleasing directive customer interface for Logos’ ALPHADAS EDC web portal.

 ·               To write highly professional and clearly structured code that will ensure high performance & user satisfaction and will enable this new interface to efficiently communicate with Logos’ central database application. 

 ·               Update and improve the presentation layer - the layout and visual impact of this interface will be critical to its success, so you will need to be highly creative and have a strong understanding of how the interface should look in terms of positioning, designs and use of colours.

 ·               To work closely with other specialist developers to create a new fully functional EDC system.

 ·               Keep up to date with how new technologies are developing and how platforms are likely to evolve.

 ·               Improve communication layers between web browsers and database servers.

 

Experience/Qualifications required

Ideal Candidate Profile

 ·               A proven ability to designing directive, fully functional interface data systems

·               Technical and theoretical knowledge and understanding of;

.NET 3.5, SQL, JAVA script, XML and HTML

·               Highly visually creative – an ability to design code that is visually appealing and user friendly.

·               Knowledge and understanding of Object Orientated design.

·               Have experience of developing technologies within the Clinical or Pharmaceutical sectors.

·               Confidence to operate in client facing situations.

 Core Candidate Profile

 ·               A proven ability to designing directive, fully functional interface data systems

·               Technical and theoretical knowledge and proven understanding of;

Windows.NET

·               Highly visually creative – an ability to design code that is visually appealing and user friendly.

·               A positive attitude and an ability to work independently and as part of a team

·               An understanding of the importance of business critical objectives and a background of delivering development projects to fixed timelines .

·               Ability to work in an agile and fast paced development environment.

·               An individual that will thrive in a technology lead entrepreneurial dynamic small team environment.

 Soft Skills

 ·               Excellent communication and organisational skills

·               Highly self-motivated detail orientated and quality driven individual

·               Strong written and oral skills and confident in client facing situations.

·               Enthusiastic, inquisitive and keen to continue in their professional learning.

 Remuneration and Package

 £30,000 – 40,000 base salary with opportunity to generate bonus payments upon successfully delivering against set objectives.

Metabolic Modeller

Reference number: 1897 Apply for this job Apply for this job »
Type: Permanent, full time Location: Hertfordshire

Job Description

Summary:            The aim is to genetically engineer microorganisms to convert sugars to bulk organic compounds, and the metabolic modeller will play a key role in devising and optimising routes to enhance carbon flux to maximise yield.

 The Role:                  

 ·         To develop and apply metabolic models in microorganisms

·         To model the effects of genetic manipulations to metabolic pathways and to refine the models based on the results from genetic engineering

·         To apply metabolic modelling and knowledge of biochemical pathways to devise novel biosynthetic routes to target molecules and strategies to optimise yield from sugars

Experience/Qualifications required

A PhD in metabolic modelling, molecular biology or bioinformatics plus postdoctoral experience in relevant areas

A good working knowledge of metabolic pathways and basic biochemistry

Experience in applying metabolic modelling in a microbial system

Some experience of practical molecular biology or microbial genetics would be an advantage