Salma Samsuddin

Experience

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  Imperial College London

  Apr 2010 - Sept 2010

  Research Associate

  Managing project looking into proteins involved in cardiac mechanosensation.Carrying out literature review, peer review of scientific articles for publicationPresentations of own work and journal club.Poster presentation of work at internal conference.Extensive data analysis using Excel software and writing reports.Setting up laboratory, general management and upkeep.Mentoring and advising undergraduate students.Sample handling/processing and performing research experiments.Successfully completed Good Clinical Practise course. Show less

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  Canary Wharf Group plc

  Dec 2010 - Jul 2017

  Science Tutor

  Tutoring 15-16 year olds with science GCSE homework, revision or coursework.Mentoring young people in their academic work, developing effective time-management / study skills, discussing career options and raising young people’s career aspirations, acting as a role-model to achieve these goals.

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  Queen Mary, University of London

  Dec 2010 - May 2011

  Research Assistant

  Working on vitamin D clinical trial (ViDiFlu), a randomised double-blind trial looking at vitamin D supplementation in elderly subjects and effects on upper respiratory tract infections.The job also includes performing clinical screens (filling our CRF’s), sample collection and processing, subject recruitment, monitoring subjects, data-entry of CRF’s and patient diary details on the main database, quality-checking/validating data, raising queries as necessary, database management, analysis and maintaining study data, visits and interviewing subjects. Continually ensuring SOPs and current guidelines such as ICH, strict patient confidentiality and GCP are adhered to. Show less

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  Queen Mary, University of London/Barts Health NHS Trust

  Jan 2012 - Jul 2017

  Research Study Coordinator/Hub Manager

  • Project Managing, coordinating and supporting the DARE study (multi-centre database genetic trial based on recruiting diabetics and controls who consent to take part in future diabetes trials/studies & donate a sample of blood for genetic analysis as well as HBA1C screening) within primary and secondary care in Essex, West Hertfordshire, and 7 London boroughs. >11,000 patients recruited• Opening the DARE study across primary & secondary care sites across Kent & South London. Ultimately initiated over 60 sites across these areas with 4000 patients recruited.• Managing a team of nurses in terms of allocating sites, setting site targets & ensuring recruitment is to target as well as adherence to protocol. • Ensuring collection & preparation of biological samples, maintaining a biobank & certifying DNA collection is performed. Creating/maintaining the TMF & local site files including protocol, CRF development, performing data entry and ensure patient records are maintained and updated as needed. • Performing site feasibility assessments for DARE & other studies & Initiating sites to take part in DARE, compiling and giving presentations (3-4 visits per week)• Providing update reports to coordinating centers at each area conducting DARE, to the sponsor & managing DARE study database.• Ensuring SOPs & current guidelines such as ICH, strict patient confidentiality & GCP are adhered to at all sites• Performing site monitoring visits/ creating monitoring templates & reports to send to coordinating centre. Also perform site closure visits. (8 monitoring visits monthly).• NTCRN study monitor-monitor all studies run by NTCRN (commercial/academic)• Filling out IRAS form for SSI/HRA amendments/REC committees• Involved in coordinating & managing two commercial CTIMP studies (phase 2/3) commercial clinical trial setup, management and recruiting. Show less

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  Great Ormond Street Hospital for Children NHS Foundation Trust

  Jul 2017 - Mar 2023

  • Project managing one of the largest paediatric neuromuscular clinical database network SMA-REACH (> 500 patients). • Stabilising ISMAC, a collaboration between the UK, Italian and American network by ensuring all contracts signed off, ensuring alignment of activities & CRF’s, facilitate publication of papers, organizing network meetings, ensuring high level deliverables met. • Ensuring objectives are met of the agreement with NICE, NHS England and the funder in providing 6 monthly datacuts. This was successfully met & high quality of these datacuts led nusinersen availability to SMA 3 NA patients. • Managing a team of 2 data managers & a coordinator, organizing regular catchup meeting the team, & devising strategies to ensure these are met. • Writing up monitoring plan & SOP, setting standards & supervise/conducting the monitoring of trial sites, to problem solve & review source data. Ensuring GCP/ICH guidelines maintained.• Ensure trial timelines are monitored & kept to schedule, including contract milestones & advising finance to raise an invoice to funder upon completion of milestone. • Successfully negotiating & facilitating the sign-off of 2 large contracts with a pharmaceutical funder worth over £500K. • Opened 17 paediatric & adult sites including completion of ethics documentation.• Setting up subcontracts & MNCA’s with NHS Trusts. • Budgeting forecasting and management, as well as providing costings to funder as part of budget extension request (successfully negotiated)• Writing up SOPS including risk assessment & amending study documentation, IRAS for submission to REC/HRA.• Setting up newborn screening program pilot study at GOSH, results of which will form part of the evidence dossier to government bodies for SMA newborn screening program to be implemented in the UK. • Setup of a steering committee.• Writing up job descriptions and interviewing • Carry over on previous responsibilities mentioned below. Show less • project Managing, coordinating and supporting 2 of the largest neuromuscular clinical database networks in the world across 23 national sites -NorthStar (patients with Duchenne Muscular Dystrophy) and SMARTNet (patients with Spinal Muscular Atrophy). Ensuring quality control of clinical data, perform regular monitoring/auditingProject managing the clinical networks including maintaining budget, oversight and management of the networks. Ensuring protocol and study procedures are adhered to. • Continually ensuring SOPs and current guidelines such as ICH, strict patient confidentiality and GCP are adhered to at all sites• Performing site monitoring visits/ creating monitoring templates and reports to send to coordinating centre. Also perform site closure visits. • Filling out IRAS form for SSI/HRA amendments, updating sites with amendments as required.• Creating and maintaining TMF, also main version control and cascade updates to sites as required.• Writing SOP’s/site file documentation including CRF.• Assisting with the coordination of departmental Phase 2 and phase 3 studies within the department. Show less

  • Trial Manager

    Apr 2019 - Mar 2023

  • National Study Coordinator/Project Manager

    Jul 2017 - Mar 2019
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  Imperial College London

  Mar 2023 - now

  Lead Clinical Trial/Project Manager

  Involved in all aspects of developing a project in an agile/matrix environment including bid development, tendering, budget forecast, scheduling and costing, resource management, vendor management, contract creation and negotiation, ensuring milestones are met, developing payment schedules, ensuring project runs within budget, developing SOP’s and closeout.Line management experience, recruiting and managing a team of 2 study coordinators, trial monitor, and 3 database managers.Working at the clinical trials unit project managing the Racemate phase 2 CTIMP sponsor led trial including setup, project management, budget management and operational oversight.Overseeing the setup, management of 16 NHS Trusts across the UK. This includes IMP management and accountability to sites. Currently in the process of applying through CTIS the opening 10 Italian sites, and facilitating international running of the trial in Italy.Measuring KPI's against milestones.CTIMP ethics applicationIn the process of requesting funding extension via drawing up the budget request.I have experience of working with a multidisciplinary team including consultants/ study PI’s, clinical staff, patient groups, funders, patients and vendors. Also part of working groups at ICTU to implement better strategies such as monitoring Show less