Mehmet Arabaci

Creative and decisive leader with an intuitive sense of what needs to get done, and an unwavering focus on driving projects through to completion. A self-motivated pharmacy professional with 5 years clinical trials implementation experience coupled with over decade organising people and resources strategically to achieve project goals on time in fast paced-high-stress environment.

Experienced across all stages of clinical development (oncology and non-oncology spanning multiple therapeutic areas) and is familiar with the latest innovations in clinical trial design and digital methodology. Currently specialising in the delivery of cell therapy trials (ATIMP's) with the Cambridge Cellular Therapy Lab (CCTL), Cambridge University Hospitals.

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Pharmacy Experience

10+ Years

Clinical Trial Implementation Experience

5+ Years

Clinical Trial SOP's Authored

30+

Trial Specific Worksheets Authored

15+

Aseptic Preparation Guides Authored

10+

Quality and Financial Agreements Negotiated

20+

What I Do

Deliver project goals on-time: recruit sooner

The key to achieving this is having a well-planned project timeline and a clear understanding of all project requirements. Unfortunately most CRO's and sponsors have little experience working on-site at a hospital and consequently wonder why their projects aren't progressing like they visualised in their Gantt chart.

Manage multiple projects in parallel by effective prioritization

Achieved by analysing each project's importance, urgency, and impact on other ongoing projects and using project management tools to visually track progress.

Cell Therapies (ATIMP's)

Trials involving gene and cell therapies seem to exist in somewhat of a grey area at the moment. Fewer centres have the facilities to run them and staffing issues can be a real road block. I have both the knowhow and the network to get ATIMP trials moving in the right direction

Write trial documentation & maximise operational efficiency

Having read and digested hundreds of Protocols', IBs' and pharmacy / cell manuals' it's safe to say I know the difference between a well written trial and a not-so-well written one. I've authored many highly optimised trial specific standard operating procedures (SOP's) for the smooth running of trials without compromising the transparency or integrity of the data.

Mitigate risks though effective planning and organisation

Identifying potential risks, assessing their likelihood and impact, and developing strategies to mitigate or control them.

Training and support

Clinical trial work can be daunting for those not engrossed in it everyday. Consequently staff need to shown and explained exactly how the trial procedures work from start to finish and how they fit in. Often sponsors skip the small details, but those small details matter.

Companies I've Worked With

Resume

10 Years of Experience

Employment History

Oct 2022 - Present
Cambridge University Hospitals NHS Foundation Trust

Clinical Trials Manager - Advanced Therapies, Cell Therapy

Predominantly remote role: 90% remote; 10% on-site

  • Increase the departments capacity to run more trials by optimising standard operating procedures for the implementation and management of clinical trials.
  • Reduce the time it takes to implement trials and open recruitment by incorporating a clear application and review process for all new trials.
  • Utilise video and teleconferencing tools to collaborate with colleagues, the wider multidisciplinary team and to facilitate training on trial procedures.
  • Incorporate regulatory compliant trial procedures by working closely with the director of CCTL, the production manager, quality manager and pharmacy department as a cross functional team
Jan 2020 - Oct 2022
Cambridge University Hospitals NHS Foundation Trust

Specialist Pharmacist - Clinical Trials

Hybrid Working Role: 50% remote: 50% on-site

  • Opened more than 25 commercial trials to recruitment and helped beat the team record for number of trials opened in a single week, collectively 8, by effectively managing multiple project timelines.
  • Enhanced workload transparency and remote collaboration by leading the implementation of Microsoft Teams and Edge Clinical.
  • Facilitated the set up and day to day running of clinical trials by liaising with the wider multi-disciplinary team (sponsors, CRO’s, PI, nurses, aseptic preps, etc) and producing local procedural documentation.
  • Integrated regulatory compliant trial procedures by adhering to the requirements of GCP, GMP, EU Clinical Trials Regulation (Pre-Brexit) and The Medicines for Human Use (Clinical Trials) Regulations 2004 (UK), MHRA, Ethics (REC), HRA, and CUH policy.
Sept 2015 - Nov 2019
Self-employed (MemPharm Ltd)

Locum Pharmacist

On-site role

  • Facilitated the safe, legal and prompt supply of medicines and pharmacy services by managing small teams of 2 – 6 pharmacy professionals (healthcare assistants, pharmacy dispensers and pharmacy technicians).
  • Clients: Asda, Brompton Pharmacy, BUPA Homecare, Clockwork Pharmacy, Day Lewis,  Island Pharmacy, Sainsburys and Tesco
Sept 2012 - July 2015
Clockwork Pharmacy

Pharmacy Manager

On-site role

  • Reduced inventory waste by optimising order quantities based on average use; generated from the pharmacy patient medical record system (PMR) and cash register (till).
  • Increased customer satisfaction by improving the number of services offered, customer service and cultivating personal relationships; prescription items processed increased 10% year-on-year.
  • Executed advanced services commissioned by the Community Pharmacy Contractual Framework for the benefit of patient health outcomes and to increase business revenue by £12,000 per annum.
  • Mentored a pre-registration pharmacist who went on the register and practice as a UK Pharmacist.
  • Launched three new services through the patient group directives (PGD) framework to add additional revenue streams to the business and increase patient access to medicines: antimalarial prophylaxis, erectile disfunction and a travel vaccination service.

Relevant Certifications

2023
AXELOS Limited

Prince 2 Foundation - Project Management Certification

Training by study365 an accredited facility by AXELOS limited 

2023
The Johns Hopkins University (via Coursera)

Design and Conduct of Clinical Trials + Clinical Trials Data Management and Quality Assurance

A course designed to help design and conduct successful clinical trials. Build skills for conducting successful and impactful clinical trials.

2023
Udemy | 365 Careers

Project Management Course

Topics Covered: Project management basics | Fundamental project management theory and best practices | Tools: Gantt charts, Critical Path Method, Project Plan, Budgets | Agile project management + SCRUM | The philosophy of Waterfall project management

2022
University of Birmingham

Introduction to Advanced Therapy Medicinal Products

Part of the Centre for Advanced Therapies Manufacturing Training.

Topics covered: Basic cell biology that underpins ATMP medicines | Technologies that are used to create ATMP medicines | Differences between point of care and centralized manufacturing – and implications on delivery to the patient | Sources of risk in delivering cell products to the clinic | Overview of the GMP manufacturing facility

2022
Smiro Qualitas Ltd

An Introduction to GMP for Cell and Gene Therapy ATMPs/ATIMPs

Topics Covered:  The regulatory framework to manufacture medicines | GMP/GDP Considerations for manufacture sites | An introduction to microbiology | Microbiology considerations for GMP facilities

2021
University of Leeds

Clinical Trials Short Course

Topics Covered: GCP/GMP legislation (including preparation for inspection) | clinical trial set-up and management | manufacture of IMPs and QP release | clinical trials in specialist areas.

January 2020 - Present
NIHR

Good Clinical Practice (GCP)

Renewed every 2 years.
Last Renewed December 2021: GCP Refresher + GCP for IMP Management

Education

2023
University of Cambridge

Novel Clinical Trial Design in Translational Medicine

A cutting-edge overview from academia and industry of the latest innovations in clinical trial design and digital methodology.

2007 - 2011
University of Manchester

Master of Pharmacy (MPharm)

Four-year Masters degree (MPharm) teaching the knowledge and practical skills needed to become a pharmacist. Grade 2.1 (with Honours); followed by 1 year placement prior to GPhC registration

Dissertation: Analysing Methods used in Population Pharmacokinetic (POP-PK) Studies with Regards to Correlations between Covariates (A meta-analysis)

2005-2007
Chislehurst and Sidcup Grammar School

A Levels

Chemistry (A) Biology (A) Geography (B) Physics AS (A)

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