Syne Qua Non | Career Opportunities | Clinical Biometrics

Principal Quality Assurance Auditor

Double Queens Award winning SQN Clinical is one of the largest specialist data focused contract research companies in Europe supporting human clinical trials developing new life saving drugs. Using its innovative Electronic Data Collection system, ePRO mobile app and related biometrics services, SQN is a market leader in the healthcare arena. The Norfolk based specialist clinical biometrics CRO is supporting global pharma, biotech, medical device and animal health partners with innovative clinical development services.

This is an exciting opportunity to join the SQN team reporting to the QA Manager, you will provide day-to-day support to the quality assurance function. You will be responsible for assisting in the management of the Quality Assurance program component within SQN and will work with our other departments to assure regulatory compliance and consistency with the policies and procedures.

Role focus:

Set up the annual quality audit programme
Ensure the quality audit programme is followed and kept up to date
Conduct reporting and follow-up of quality system, computer system validation and service provider audits
Ensure audit results are formally recorded and reported and that corrective/preventative actions are documented
Maintain the approved service provider list
Oversee production of the monthly QA report to management using QA metrics and escalate any issues for concern to the Head of QA
Production of the annual trend analysis using QA metrics
Where required, produce training documentation relating to quality and regulatory areas for both QA and SQN. Participate in Client audits and regulatory Inspections (preparation, hosting, responses and follow up of corrective action plans)
Assist in the management, training and mentorship of our team of QA auditors and provide guidance on internal and external audits

Areas of required expertise and experience

GCP and CSV QA experience
Experience with assisting and managing QA audits and inspections as well as interfacing with regulatory agencies
Experience in the management of documents (Policies, SOPs etc.)
Expert knowledge of GCP and applicable regulations
Demonstrates leadership ability, communication, and facilitation skills
Be able to work on own initiative and able to function independently or as part of a team
Self-motivated

The role can be office or home based.

If you have the necessary experience, qualifications and skills and are interested in being considered for this full time, permanent, position please submit your application to: info@synequanon.com

Head of Business Development

This is an exciting new opportunity to support the continued growth of SQN. We are looking to create a new Business Development function within our organisation and are seeking an experienced Senior Business Development Director who can build and grow a new team around them. You must be a self-starting, enthusiastic individual who wishes to make a real impact in our growing organisation.

The successful candidate will be responsible for the development and expansion of new business opportunities with existing and established clients and new clients by providing leadership for overall business planning. You will identify and develop new business leads and liaise with our Proposal and Contracts administration team in managing the sales process through to contract closure. You will prepare and conduct project-specific client presentations in collaboration with our functional departments related to SQN’s core services and capabilities. You will liaise with client and SQN teams on all business development activities and requirements; will expand on SQN’s successful 23 Year history as a quality and technology-based Biometrics company.

Internally, the Head of Business Development will work closely with our Project Management team to establish and maintain partnerships with new and existing clients as well as with all the other functional teams within SQN to enhance performance and client relations.

Key Responsibilities

Identify new potential clients.
Establish and maintain contact with pharmaceutical, biotechnology and clinical CRO’s to gain knowledge of drug development pipelines, promote SQN’s services, and increase the number of studies for which SQN is asked to bid on.
Prepare and present SQN’s core services and capabilities to new and existing clients
Visit prospective clients to introduce our capabilities and therapeutic experience to create new business relationships towards the achievement of targeted annual revenue goals.
Participate in the development of plans for service promotion in support of our sales and marketing objectives.
Generate and qualify new business opportunities.
Work with our Proposal and Contract administration team on the creation of competitive study bid proposals and liaise with our clients throughout the bidding process.
Continue to support and maintain the high levels of repeat business through nurturing the relationships with our existing clients and ensuring a quality service and delivery satisfaction.
Promote SQN to expand its market and increase our client base.
Establish and maintain contact with SQN’s 3^rd party service providers to support our projects to add value or provide additional functionality, as required.
Attend and participate at conferences and trade shows and follow-up on contacts made during these events.
Review and process contractual documents, including CDA’s, LOI’s, MSA’s and Task Orders and oversee changes in scope, as required.
Assist our Finance team with billing and revenue recognition as required.

Relevant Qualifications, Experience and Abilities

Bachelor’s Degree in a business, science, or related field.
At least 5 years’ experience as a BD Director in a CRO environment with a sound knowledge of biometrics services including EDC and ePRO services.
Thorough understanding of the clinical trial process
Proven sales experience within a biometrics or full-service CRO, selling statistics, data management, programming and medical writing services.
Strong presentation skills (to prepare and deliver high-quality capabilities, sales and bid defence presentations).
Strong listening, communication and interpersonal skills along with excellent oral and written communication skills.
Experience with proposal development, contract negotiation and closing a contract.
Ability to learn quickly and assimilate the detail of project requirements.
Adaptability and flexibility to changing priorities with attention to detail and ability to work simultaneously on multiple priorities
Good computer skills, including use of Word, Excel, PowerPoint and CRM software
Demonstrated ability to work creatively and effectively in a fast-paced CRO environment
You must be able to travel up to 50% of the time.
This role is a full-time position and can be located anywhere, UK – home based.

If this role and profile supports your career development aspirations, we would be interested in receiving your CV and discussing this exciting opportunity with you further.

If you have the necessary experience, qualifications and skills and are interested in being considered for this full time, permanent, position please submit
your application to: info@synequanon.com

Marketing Manager

This is an exciting and varied opportunity to join a growing company and help conceive and execute a broad range of marketing initiatives that will strengthen the company’s position in the market and generate inbound leads from potential clients in need of our services.

Areas of responsibility include:

Continue to own and establish SQN clinicals position in the market for the medium to long term, raising the profile and reinforce SQN’s message to all stakeholders (New and existing clients, partners and internal)
Plan and create a marketing strategy that builds upon the current strategy for growth.

Marketing Strategy

Create a quarterly plan and calendar to execute the marketing strategy
Be responsible for management of the marketing budgets
Ensuring internal employees have a good understanding of our internal activities and message

Content Marketing

Develop a content plan around business needs and objectives
Lead the maintenance of SQN’s website, ensuring all messages and news is up to date
Research and co-create insightful content that can contribute towards the content plan. Liaise with operational leads to lean on experts within the business to help with directions.
Maintain our social engagement for SQN (LinkedIn, Twitter and Facebook)
Maintain and organise email marketing campaigns and newsletters
Support the development and distribution of press releases through agencies
Support and manage ad distribution with publications.

Digital Marketing

Plan and execute all digital marketing, including SEO, LinkedIn advertising, email, and social campaigns
Identify trends and insights and optimise spend and performance based on these insights.

Branding and Collateral

Follow company brand guidelines to execute the design of marketing collateral, both digital and offline.
Oversee the development of various inter-department collateral which is external facing
Ensure all collateral is up to date and reflective of the SQN brand and message
Liaise with our brand agency to create complex design work

Business Development

Ensure the business is developing successful lead generation campaigns
Work with business development to support the sales process from a marketing perspective
Monitor CRM activities to identify marketing behaviour across new and existing leads

Reporting

Monitor and report on all marketing channels which should be presented to senior management on a monthly basis
Contribute and suggest what is working/not working and suggest changes and enhancements to activity
Work to an agreed budget, track and monitor costs throughout
Measure performance of activities and access against KPI’s and ROI.

Requirements

A degree in marketing or related discipline e.g. CIM
3-5 years’ experience in a similar role
Life sciences experience preferable
Strong analytical skills and a comprehensive understanding of google analytics
Knowledge of marketing/ social and CRM technologies, with specific experience in ZOHO preferable but not essential
Experience managing third-party/ vendors
Organised and self-driven
Strong written and content creation skills

If you have the necessary experience, qualifications and skills and are interested in being considered for this full-time permanent position please submit your application to: info@synequanon.com

Principal Statistician

Double Queens Award winning SQN Clinical is one of the largest specialist data focused contract research companies in Europe supporting human clinical trials developing new life-saving drugs. Using its innovative Electronic Data Collection system, ePRO mobile app and related biometrics services, SQN is a market leader in the healthcare arena. The Norfolk based specialist clinical biometrics CRO is supporting global pharma, biotech, medical device and animal health partners with innovative clinical development services.

This is an exciting and varied opportunity to join a well-established team with responsibility for leading all statistical activities relating to clinical trial projects. Being a statistical expert able to provide statistical consultancy in specific areas.

Areas of responsibility include:

Providing statistical expert point of contact with sponsor and internal project teams
Randomisation design, Protocol and sample size consultancy
Performing the Lead Statistician role on varied and complex projects; delivering to client expectations and within budget
Development of Statistical Analysis Plans
Covering a variety of statistical consultancy, programming, and modeling based on the awarded work, for example:
- ISS/ISE
- Meta-analysis
- PK/PD and bioequivalence studies
- Mixed models
- Adaptive designs
- Survival analysis
Supporting the development and expansion of statistical expertise at SQN
Peer review of statistical deliverables
Providing statistical expertise and presentation of results at sponsor meetings
Providing statistical evaluation and reports for inclusion into Clinical Study Reports

General responsibilities include:

Advising on statistical issues, expanding the department’s knowledge base
Contributing to SQN’s development of new systems, processes, and SOPs
Business development expert support – contributing to proposals, contracts, and meetings
Ability to communicate effectively with non-statisticians

Experience and skills required:

Strong analytical and data interpretation skills
Advanced statistical expertise in a variety of area and topics
Statistical programming and modeling with experience across a wide variety of topics
Experience in Integration studies preferred
Minimum of 5 years in a CRO environment and an MSc or Ph.D. in Statistics
Excellent project management, organisational and matrix management skills with the ability to proactively prioritise projects
Budgeting and resourcing skills
Leadership and mentoring skills
Commercial awareness
Experience with SAS v. 9
Wide clinical development knowledge across Phase I through IV studies, real world, integration studies

If you have the necessary experience, qualifications and skills and are interested in being considered for this full-time permanent position please submit your application to: info@synequanon.com

Principal SAS Programmer

Job Description: Responsible for statistical programming activities relating to clinical trials. Principal programmer will additionally be responsible for leading the programming activities on studies

Areas of responsibility include:

Primary areas:

CDISC SDTM and ADAM mapping and programming. Creation of SDTM and ADAM mapping specs, SDTM and ADAM defines and reviewer’s guides
Provision of expert advice and technical support to study teams
Principal role will include project leadership activities

Additional areas:

Development of analysis dataset specifications
Development, maintenance and validation of SAS® programs for the production of analysis datasets and tables, figures and listings for inclusion in clinical study reports
Creation and review of shells for tables, figures and listings from a programming perspective
Development, maintenance and validation of SAS based utilities
Data capture design review and input into data standards
Lead role in SQN’s development of new systems, processes and SOPs

Experience and skills required:

Current and extensive proven technical experience performing this role with a proven track record in leading study teams
Subject matter expert in one or more areas
Self-motivated with the ability to motivate others
Expertise in CDSIC SDTM standards, including thorough understanding of SDTM IG, creation of SDTM mapping specifications, defines and reviewer’s guides. Experience in the conversion of data sets into SDTMs
The equivalent knowledge of ADaM standards essential
Experience of running data integration projects
Strong analytical, programming and data interpretation skills
Minimum of 8-9 years SAS® programming experience ideally in the CRO environment
Good organisational skills with the ability to proactively prioritise projects and allocated activities
Experience of leading project teams, forecasting work and assessing progress
Budgeting and resourcing skills
Leadership and mentoring skills
Commercial awareness
Practical experience with SAS v 9 and macro development
Understanding of clinical development processes
Excellent communication skills and high level of English language

If you have the necessary experience, qualifications and skills and are interested in being considered for this full time permanent position please submit your application and CV to: info@synequanon.com

Team Leader, SAS Programming

This is an exciting and varied opportunity to join a well-established team with responsibility for the Provision of line management services to the SAS programming function, ensuring effective management of studies and resources and successful delivery of SQN projects according to SQN Standard Operating Procedures and agreed study contracts.

Areas of responsibility include:

Function as the Line Manager for SAS® Programming Team. Provide training, mentoring and support. Identify problems and provide solutions.
Supervise the smooth running of all programming activities for the production of tables, figures, listings and datasets, SDTM and ADaM dataset mapping and other SAS® related deliverables, according to specifications, within agreed timelines and budget, to high quality standards.
Ensure adequate resources are available to support ongoing and future programming activities; identify potential shortcomings early and propose suitable solutions.
Support the recruitment process for talent acquisition to the SAS Programming team.
Allocate Lead Programmer to each study and ensure that they proactively manage the study resource demands, timelines and study risks where these arise.
Monitor the resource utilisation within the SAS® Programming Team against assigned budget; support project teams in the identification of out-of-scope work and the tracking project progress against milestones.
When required act as project manager to ensure projects meet deadlines and remain within scope and budget and are run according to SQN SOP’s or Client’s standard and agreed working practices.
Oversee and drive the development of generic reporting tools where appropriate to ensure consistency and maximise efficiencies.
Promote the sharing of efficient practices within the SAS® Programming Team and beyond.
Contribute to SQN’s financial planning by providing programming-specific input into quotations.
Attend bid-defence meetings as required, or provide background material
Lead process improvement initiatives within the SAS® Programming Team; contribute to cross-departmental initiatives, especially between Statistics, Data Management, Project Management and IT.
Participate in external meetings with clients, and in conferences as appropriate; prepare and deliver presentations.
Contribute to the management and planning of the Statistics and Programming department.
Further responsibilities may be delegated by management, as appropriate.

Applicants should be experienced SAS programmers, with a background in the CRO or Pharma industry. Experience of line management of small teams is required, along with good interpersonal and organisational skills.

The role can be office based or home based.

If you have the necessary experience, qualifications and skills and are interested in being considered for this full-time permanent position please submit your application to: info@synequanon.com

Senior SAS Programmer

Job Description: Responsible for the leadership and delivery of statistical programming activities relating to clinical trials.

Areas of responsibility include:

Primary areas:

Acting as Lead Programmer across multiple studies
Creation of CDISC compliant SDTM and ADaM programs and supporting documentation
Senior role will include project leadership activities

Additional areas:

Development, maintenance and validation of SAS® programs for the production of analysis datasets and tables, figures and listings for inclusion in clinical study reports
Creation and review of shells for tables, figures and listings from a programming perspective
Development, maintenance and validation of SAS based utilities
Data capture design review and input into data standards
Contributing to SQN’s development of new systems, processes and SOPs

Experience and skills required:

Expertise in CDSIC standards, including a thorough understanding of SDTM/ ADaM IG, creation of SDTM and ADaM mapping specifications, defines and reviewer’s guides.
Experience in the conversion of data sets into SDTMs
Experience of running data integration projects
Strong analytical, programming and data interpretation skills
Minimum of 5-6 years SAS® programming experience ideally in the CRO environment
Good organisational skills with the ability to proactively prioritise projects and allocated activities
Experience of leading project teams, forecasting work and assessing progress
Budgeting and resourcing skills
Leadership and mentoring skills
Commercial awareness
Practical experience with SAS v 9 and macro development
Understanding of clinical development processes
Good communication skills and high level of English language

If you have the necessary experience, qualifications and skills and are interested in being considered for this full-time permanent position then please submit your application and CV to: info@synequanon.com

Senior Data Manager

This is an exciting and varied opportunity to join a well-established team with responsibility for leading all data management activities relating to clinical trial projects. Being a data management expert able to provide guidance and direction to both clients and team members.

Areas of responsibility include:

Performing the Lead Data Manager role with responsibility for the successful quality, planning, execution, monitoring, control and finalisation of all data management activities with effective management of timelines, budget and quality.

Planning: Definition and maintenance of Data Management project plan, input into the overall project plan. Responsible for the execution of all data management aspects of the project plan and reporting of status across the SQN project team.
Resourcing: Definition of Data Management resource needs for the life time of the study including the identification and communication of short-term resource fluctuations. Flexible and efficient use of assigned resource.
Documentation: Implementation and maintenance of accurate, clear Data Management documentation. Responsible for the setup, maintenance and finalisation of the Data Management Study File
Study Team Management: Oversight of all data review activities; measuring progress against the project plan.
Contract and Budget: Detailed knowledge and understanding of contracted Data Management obligations and associated budget; Ongoing assessment of budget, regular and accurate review of Data Management progress against financial milestones and monthly completion metrics.
Client Management: Leads and drives all Data Management communication and acts as the primary client contact for Data Management activities
Risk management and Escalation: Identifies, manages and communicates risk to timelines, quality and budget.
Contributes to the ongoing development of the Data Management department through process analysis and improvement, mentoring, system enhancement.
Liaises successfully with colleagues across the company to achieve a cohesive and co-ordinated service to our clients and the development of a strong Syne qua non team spirit. Supports Syne qua non’s business development activities.
To effectively support regulatory and sponsor audits

If you have the necessary experience, qualifications and skills and are interested in being considered for this full-time permanent position please submit your application to: info@synequanon.com