Steffan Stringer BSc PRINCE2® MICR MRQA
Alwyn Consulting, Aug 2015 to Present
Principal Consultant, Guildford, Aug 2015 to Present
Providing consulting, freelancing and interim management services covering Project Management, Quality Management and General Management in the clinical research and life sciences sectors.
OmniComm Systems, Aug 2014 to Aug 2015
Director, Early Phase Consulting, Southampton, Aug 2014 to Aug 2015
Reporting to the Chairman of the Board / Chief Technology Officer, helping implement and deploy TrialOne, the standards compliant eSource and automation solution for early phase clinical research units.
Conducting pre-sales meetings with customers to review TrialOne eSource/automation software. Analysing business needs of Phase I Units and advising on strategy for software implementation. Process mapping; supporting system implementation; change management. Responsible for overall project quality, timeliness and customer satisfaction.
Alwyn Consulting, Dec 2009 to Aug 2014
Principal Consultant, Guildford, Dec 2009 to Aug 2014
Providing consulting, freelancing and interim management services covering Project Management, Quality Management and General Management in the clinical research and life sciences sectors. Example responsibilities, roles and achievements:
- Analysis of CRO quality model and provision of recommendations to improve efficiency and effectiveness.
- Project managed multiple Electronic Data Capture (EDC) implementations for niche vendor.
- Led validation for multiple EDC system validations.
- Implemented Customer Relationship Management (CRM), Project Management and Intranet tools.
- Interim Quality Manager.
- Hosted client audits and managed the corrective action process.
- Conducted ‘For Cause’ audits of clinical and laboratory facilities and trial data and prepared a business improvement plan for Board of Directors of German contract research organisation (CRO).
- Undertook review of Hungarian CRO's processes and structure and provided plan for strategic change.
- Conducted technology assessment for UK based biotechnology consulting firm.
PAREXEL International, 2000 to 2009
Worldwide Head, Early Phase Clinical Data Services, Uxbridge, Jul 2008 – Nov 2009
- Reporting to the Corporate Vice President for Early Phase, planned and managed the integration of programmers, statisticians, data managers, medical writing and technical services staff into a global biometrics business (130 staff) in US, UK, Germany and South Africa.
- Held full P&L responsibility for a $16M budget.
- Refocused service delivery into a 'Centre of Excellence' with an onshore/offshore model and introduced an account management approach.
- Routine and regular client contact to manage planning and performance monitoring of full service clinical trials.
- Oversaw the strategy and execution of an annual $2M spend on clinical hardware and software (ECG equipment, bedside data capture systems etc.).
- Responsible for maintenance and management of medical technology in all Clinical Pharmacology Units.
- Reorganised the way that Pharmacokinetic services were delivered by partnering with the medical group and redefining the role of scientists in the team.
- Represented biometrics in $80M strategic outsourcing partnership with major pharmaceutical company.
Senior Director, Early Phase QM & Systems Integration, Uxbridge, Sep 2004 – Jun 2008
- Reporting directly to the Corporate VP of Clinical Pharmacology and responsible for process improvement, technology and process harmonisation projects worldwide (two bioanalytical laboratories, 10 clinical research facilities - France, Germany, UK, US and South Africa).
- Matrix report of the VP of Corporate Quality and responsible for Quality Management within the Clinical Pharmacology division.
- Responsible for the deployment of learning management (SumTotal), controlled document management (Open Text Livelink), contact management (Salesforce), and eSource & clinical trial management (ClinBase™) systems in Early Phase division.
- Standardised the customer satisfaction survey process and managed the development of corporate quality metrics across five individual business units.
- Assisted with the due diligence, technical and management integration of companies acquired in California and Germany.
- Hosted and supported regulatory authority inspections in the US and UK.
Unit Head, Baltimore, MD, USA, Apr 2004 – Sep 2004
- Reporting to the Corporate Vice President for Clinical Pharmacology, managed a 52-bed Phase I Unit including responsibility for Operations, Programming, Data Management, Biostatistics, Medical, Scientific, Medical Writing, Quality Management, Sales departments.
- Full responsibility for strategic planning and the P&L for the business.
One year sabbatical, Apr 2003 – Mar 2004
Operations Director, Harrow, Apr 2001 – Mar 2003
- Reporting to the Medical Director and leading a team of technical, nursing, scientific and administrative staff to deliver the highest quality clinical research whilst maintaining tight controls on costs of a Phase I Unit.
- Conducted a broad range of early development trials including First into Man, Drug Interaction, Food Effect and Bioequivalence Trials.
Consultant Unit Manager, Harrow, Sep 2000 – Mar 2001
- Reporting to a PAREXEL board member, started the transition of a 24-bed unit from an R&D cost centre in a pharmaceutical company to a profit centre in a contract research organisation (CRO).
- Improved operational planning and resourcing processes and introduced project management tools and methods.
Covance Inc, 1991 - 2000
Associate Director, Centre for Exploratory Medicine, Maidenhead, Apr 1996 – Jul 2000
- Led the turnaround of a Phase II business unit and grew it from 16 to 52 staff (325%) and revenue from £550K to £2.5M (455%) in three years.
- Managed an integrated sales, clinical, medical, data management and biostatistics team to deliver headline results in proof of concept patient trials.
- Responsible for the conduct of pan-European Phase I & II trials in patient populations in a wide variety of therapeutic areas.
- Established and managed two clinical trial units within UK hospitals as 'Site Management Organisations'.
- Pioneered Covance's first use of EDC in clinical trials (IBM’s Clinware™).
Operations Manager, Phase I, Leeds, Jan 1993 – Mar 1996
- Promoted to manage over 100 technical, nursing, administrative and IT staff in a Phase I Unit in order to recruit & screen healthy volunteers and to conduct clinical trials.
- Responsible for maintaining a flexible, highly trained workforce conducting between 60 and 70 Phase I trials each year.
- Managed the transition of a Technical Team and IT Department to ISO 9001 Accreditation.
- Produced Covance's first Website for subject recruitment.
Senior QA Officer/Head QA, Phase I, Leeds, Oct 1991 – Dec 1992
- Hired to setup and develop a Clinical QA group for a busy Phase I Unit.
- Trained as ISO 9001 Lead Assessor.
Simbec Research, Merthyr Tydfil, 1988 - 1991
- Project Leader, Quality Assurance, Jan 1990 – Sep 1991.
- Clinical Research Technician, Nov 1988 – Dec 1989.
- BSc (Joint Honours) Zoology and Genetics, 1987, Cardiff University, Wales.
- PRINCE2® Practitioner, 2013, APMG International - qualified project manager.
- Regular participant in extended board meetings of EUFEMED (European Federation for Exploratory Medicines Development)
- Director and board member of the Institute of Clinical Research (ICR).
- Past chair of ICR's Freelancer Special Interest Group (SIG).
- Member of ICR's Project Management SIG.
- Member of the Research Quality Association (RQA).
- Treasurer and Committee Member of Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI).