Vikram Ratnu Email & Phone Number

London, England, United Kingdom

• Actively participating in the formulation of policies and processes, and the sharing of information.• Reviewing translational projects to identify potential need for human tissues and proactively work with researchers to procure routes to obtain them.• Working according to regulatory requirements (HTA, GCP, GDPR etc.) to ensure all translational projects involving human samples or subjects fulfil the requirements.• Liaising with commercial organisations, universities, teaching hospitals, biobanks and BRCs.• Sign-posting interest between the Crick and the BRCs to nurture clinical research collaboration.• Working with and educating researchers in the use of human biological samples.• Sourcing and providing guidance to researchers in obtaining human samples.• Producing relevant document/policies/SOPs for clinical samples and processes relevant to the projects.• Ensure researchers are aware of their ethical, regulatory and data protection obligations.

London, England, United Kingdom

• Management of a clinical research portfolio with regards to the legal framework surrounding clinical research, not limited to ICH-GCP, HTA and GDPR.• Research governance support to researchers ensuring proper conduct of clinical research projects.• Coordinating research study approval/amendment/progress report submissions to HRA Research Ethics Committee/Confidential Authority Governance, local NHS (R&D) and the Sponsor.• Liaising with other organisation’s R&D departments to facilitate transfers of data, responsibilities and biospecimens.• Responsibility of setting-up new trials and processing amendments to existing trials. This includes producing costing templates (academic), negotiation of trial costs and cross-departmental liaison with R&D and support services to confirm capability and capacity.• Continuous liaison with sponsors for study coordination and support in site monitoring.• Responsibility of maintaining source data including trial site files.• Experience with hospital-specific data-systems e.g electronic patient records.• Team-working with data managers, consultants, research nurses and across departments to ensure study requirements are met.• Experienced in trial set-up and running of trials across shared care centres.• Responsibility of assisting in audit and addressing queries raised.• Working knowledge of the current UK research infrastructure, systems, and policies and GCP.• Experienced in trial close out procedures e.g. close out visits, archiving and organising destruction of IMP.

Friedberg, Hesse, Germany

• Conduct market research and analysis of innovative technologies in various scientific disciplines including life sciences, healthcare, and clinical trials.• Advice and support client companies in the development of their products or help them navigate academic literature.• Connect mechanistic in-vitro and in-vivo studies with human studies which converge on an indication for which the potential compound/molecule is effective.• Preparing study reports (with supporting graphs, maps, and references) within strict deadlines.

Berlin, Germany

• Prepared submission folders for the application of clinical trials to Ethics Committee, Regulatoryand Local Authorities.• Facilitated communication with the authorities and regulatory bodies regarding the approval ofClinical Trials, notification for initiation of a Clinical Study and submission of Clinical Study Report• Maintained study documentation as a paper and electronic Trial Master File (TMF).• Drafted and reviewed study related documents (risk management plan, study timelines, greenlightform, SOP list, data management plan, monitoring plan and lab manuals).• Participated in internal and external communication and in regular TCs (protocol resolutionmeeting, SIV, qualification/pretrial audit, site preparation meeting).• Supported project managers in administrative and organizational tasks.

Heidelberg Area, Germany

• Extensive experience of research methodology and techniques in the field of Neuroscience/Psychiatry.• Established and lead project spread across international sites (Rome, Heidelberg and Zurich) with active coordination of multidisciplinary staff.• Expertise in preparation and delivery of lentiviral vehicles following Good Laboratory Practices (GLP) and Standard Operating Procedure (SOP).• Managed complex mouse model studies (defined severity categories, submitted ethics application) according to established regulations (EU Parliament 2010/63/EU, Article 43).• Experience in publishing peer review articles (17 articles in reputed journals like Nature Neuroscience, Molecular Psychiatry etc.)

Brisbane, Australia

• Successfully developed and executed novel project ideas using database and literature mining, brainstorming, rigorous planning, evaluation and execution.• Updated, simplified and harmonized lab protocols for accuracy, quality and consistency of data. • Experienced in preparation of scientific documents (abstracts, grants and manuscripts).• Expertise in handling and analysing large scale experimental data in accordance with scientific standards.• Provided scientific-technical expertise and training to research units staff (animal house, core facilities) for new technology and products using latest information and updated protocols.

New Delhi Area, India

• Handled category I, transgenic Wheat, requiring S2 level lab containment.• Trained in risk/benefit analysis of plant transgenic trials for Institutional Biosafety committee.

Postgraduate Program In Clinical Trial Management, Clinical Trial Management

• Clinical Monitoring • Pharmacovigilance • Clinical Statistics • Guidelines and law according to ICH-GCP, Regulatory affairs • Drug.

Doctor Of Philosophy - Phd, Neurobiology And Neurosciences

Master'S Degree, Botany/Plant Biology

Bachelor'S Degree In Science And Education (B.Sc.B.Ed., Life Science And Education