Umar Masood Email & Phone Number

United Kingdom

• Outsourced to provide leadership and expertise in all aspects of Data Management and Clinical Data and Database Programming to a single large pharmaceutical company.• Managed the delivery of all relevant data operations activities from database setup through database lock and data transfers.• Author and/or review documents such as Data Management Plan, eCRF Completion Guidelines, Database Closure Plans, Database Release Plans, Trial Specific Data Transfer Agreements for external data etc.• Ensure a high degree of data quality, accuracy and integrity especially focused on external data from a range of different vendors with short timelines. Data types included IXRS, Safety Labs, ECG, MRI, PK, PD, ADA, CSF, Tissue, Clinical Genotyping and eManifests.• Coordinated with the relevant Data Operations team members and their activities across all geographies.• Liaised with project leadership, other functional leaders (clinical, biostatistics, medical, medical writing etc.) and the client as a single point of contact.• Ensured that the contracted data deliverables are being met – specifically in terms of timeliness, financial management and quality.• Mentored other team members from around the world in Data Management activities and provided training on topics as a Subject Matter Expert.• Participate in internal and/or third-party audits for data management.

United Kingdom

• Serve as the primary contact for internal and external team members regarding data management activities.• Develop timelines and oversees timeliness of data management activities during the life cycle of studies.• Track milestones, tasks, and the overall budget for assigned projects.• Communicate proactively to all internal and external stakeholders on any data management related deliverables.• Forecast units, hours, and resourcing for data management tasks.• Author documents such as Data Management Plans, interim lock plans, database closure plans, and database unlocking plans.• Participate in client and/or third-party audits for data management.• Contribute to bid and proposal development and participates in bid defense meetings.

Leeds, United Kingdom

• Provide Data Management leadership for all aspects of the data management process to include but not limited to the development of the project documentation, system set-up, data entry and data validation procedures and processes assigned to more junior staff. • Responsible for all data management activities leading to database lock according to Client quality expectations, within project timelines and budgets.• Develop and maintain a close liaison with project client contacts, core team members, and Project Managers to drive the data management aspects of project delivery.• Perform data management tasks including data review and query management and reconciliation of the clinical database.• Review clinical trial data in accordance with Data Management Plans, Edit Check Specifications and/or Data Review Guidelines.• Generate, resolve and track queries to address problematic data identified during review using ancillary programs (diagnostics, special listings, reconciliation discrepancy listings).• Provide additional support to team as part of global decommissioning team and gatekeeping potentially unblinding data prior to passing to blinded members.

Leeds, United Kingdom

• Responsible for analysis of raw materials, finished products, stability testing and some analytical support activities including method transfers.• Used a range of analytical and wet chemistry techniques such as High Performance Liquid Chromatography, Thin Layer Chromatography, Refractive Index, Density and Titrations.• All work carried out in accordance with standard operating procedures, pharmacopoeia monographs, good laboratory practice and good manufacturing practice amongst others.

Harrogate, United Kingdom

• Provide analytical support in the drug development pathway for the characterisation and stability assessment of large protein molecules, including: vaccines, antibodies, cytokines and growth factors. • The accurate characterisation of a drug is necessary to release manufactured batches of the drug, assess stability (shelf life) and evaluate the impact of changes in manufacturing process or in formulation. • This is achieved using a range of High Performance Liquid Chromatography techniques such as: reverse phase, size exclusion and strong cation exchange chromatography.

Rochdale, United Kingdom

• Worked closely as part of a team involved in spectacle repairs, advice and sales.• Gained a better understanding with the community and has helped to build confidence when dealing with a wide range of patients with different needs.• Often worked to a very strict deadline.• Helped complete a range of administration duties which had to be completed to a high degree of accuracy and required attention to detail.• Used a range of communication methods to communicate with patients, other organisations and colleagues in other branches.

Bradford, United Kingdom

• Carried out weekly and daily maintenance activities of a NanoHPLC instrument.• Gained proficiency using the NanoHPLC instrument in separating samples onto a target plate.• Analysis was carried out using a MALDI-TOF/TOF mass spectrometer.• Assisted with the optimisation of NanoHPLC elution buffer gradient for 4-plex and 8-plex iTRAQ labelled protein samples.• Analysed data obtained from mass spectrometer.• Method evaluation and optimisation of experiments involving the use of Strepdavidin magnetic beads and biotinylated probes.• Gained experience with SDS-PAGE, Western Blot and analysis of data obtained.

Bradford, United Kingdom

Project Title: Comparison of protein profiles in hepatocellular cell lines and primary human hepatocytes.• During the MSc programme and project skills gained included an excellent knowledge of basic laboratory techniques such as cell culture (HEPG2, HUVEC and more), mass spectrometry, electrophoresis, cell function assays (MTT, clacium flux etc.) and different types of chromatography.• Also gained competency in carrying out more advanced techniques such as protein preparation (solubilisation, sonication, trypsin digestion, iTRAQ labelling) and strong cation exchange chromatography.• Proteins were separated onto a target plate using a NanoHPLC instrument and analysed using a MALDI-TOF/TOF mass spectrometer. • Data from the mass spectrometer was identified using database searching and changes between the different concentrations in each cell types were calculated. • Results from the research project were exciting as they may be important in defining future pharmacoproteomic experimental design for new drug evaluation experiments.

Bradford, United Kingdom

Project Title: Assessing the treatments for endometriosis.• During the final year project, Human Umbilical Vein Endothelial Cells (HUVECs) were obtained from fresh umbilical cords from Bradford Royal Infirmary and were cultured.• A range of techniques were used such as pipetting, coating flasks with gelatine, plating Matrigel complex, cell staining, microscopy (phase contrast) and the use of assay kits (MTT assay).• Other skills included the ability to carefully handle and interpret data for analysis using database searching, qualitative data and a range of statistical methods.• Exceptional time management, use of own initiative and excellent organisation.• Strong written and verbal communication skills.

Master Of Science (Msc), Drug Toxicology And Safety Pharmacology, Merit

Activities and Societies: Team Bradford Badminton Club Treasurer and Men's 2nd Team Captain

Home Office Modules 1, 2 And 3 For Animals (Scientific Procedures), Home Office Training For Animals (Scientific Procedures)

I have successfully completed the Home Office Modules 1, 2 and 3 for Animals (Scientific Procedures) Act, 1986 at the University.

Bachelor Of Science (Bsc), Biomedical Science, Second Class Honours

Activities and Societies: Team Bradford Badminton Club