Vidya Math

• Highly effective Programme Manager/ Project Manager and Vendor Manager, working across a diversity of pharma and lab related functions and external companies
• Drug discovery to Clinical Trials (global, all phases) project and vendor oversight
• Proficient stakeholder manager, trainer and team leader, ensuring successful and timely project delivery, with expert team building and motivational skills
• Strong planning and prioritisation skills, maintaining a crucial balance between Operational Efficiency, Health and Safety and Quality Management.
• A capacity to address new challenges effectively on a frequent basis
• High level, successful risk identification and mitigation
• Large budget PO and invoice management
• Prompt communications and management of expectations with consistent meeting of deadlines, whilst achieving high standards
• Process-oriented with the ability to promote team enthusiasm for and adherence to policies and procedures
• Six years successful experience of Clinical Trial project delivery

Jan 2020 – Feb 2024 Associate Director (Clinical Trials) – Biosampling Project Leader, AstraZeneca:

• First point of contact for Sponsor, Trial Management Vendor and CRO stakeholders for operations on drug development programmes/ clinical trials and escalations, communicating information to key stakeholders, while delivering programmes on time and to budget
• Oversight of clinical study sample lifecycles to ensure timely operations and compliance, including instruction of CROs for the creation of statements of work, to ensure CROs deliver on time and to Sponsor remit
• Sponsor oversight of vendor central laboratory activities in all clinical studies on assigned programmes, using best practice project management and communication skills for strong team-building and team efficiency
• Operational oversight of the management of human biological sampling in clinical trial programmes from project concept through implementation to project close 
• Ensuring strategy for the project sampling plan is deployed and lessons learnt within and across programmes are documented and communicated to study level personnel, for effective risk identification and mitigation and success of future projects
• Oversight of delivery of services from external providers at both programme and study levels to identify and mitigate potential risks ahead of time and to ensure deadlines and project remits are met 
• First point of escalation for biosampling requirements/ issues/ risks to all internal and external stakeholders to provide expertise for study set-up and to resolve problems while maintaining key business relationships 
• Review of clinical study protocols and informed consent forms to ensure patient-centricity and compliance with regulatory requirements and company policies
• Subject Matter Expert contribution to the AstraZeneca Clinical Sampling team to develop and provide training/ support to peers on specific areas of expertise such as AZ clinical trial study models and the creation of new processes and training materials for the training and support of peers and departmental managers

Jan 2019 – Oct 2019 (contract) Scientific Project Manager/ Operations Manager, AstraZeneca:

• Managing operations and internal and external stakeholders for a franchise in Oncology, Precision Medicine to ensure achievement of dual-Pharma objectives, in line with alliance strategy
• Managing interactions with diagnostic company partners for the successful tracking of clinical studies to ensure vendor compliance with AZ requirements and quality systems
• Co-ordination of the different business areas involved on a project to ensure adherence to deadlines through removing obstacles to day to day operations
• Carrying out Operational Due Diligence on international vendor companies to enable timely execution of clinical study contracts to meet compliance standards and procurement requirements
• Updating the AZ Project Management System PLANIT relating to study level budgets, POs and invoices from a range of providers including contractors and suppliers
• Tracking the allocation of staff resources on the franchise and identifying resourcing gaps for effective project coverage to deliver on time meeting all required project goals
• Central point of contact for diagnostic experts, alliance managers, laboratory services, procurement, partner companies and vendors ensuring impactful communication between key stakeholders
• Chairing of weekly planning meetings for the franchise, distribution of agendas and compiling of minutes ensuring no loss of key communications or action points
• Creation and management of purchase orders in association with vendor contracts and clinical trials budgets; approval of large invoices, cross-checked with complex orders ensuring all services and products were delivered within budget in line with company commercial strategy
• Writing and review of project management processes, as part of continuous improvement to allow for team developments
• Maintenance of franchise trackers to identify risks and governance concerns
• Compilation of summary documents for distribution to the team and cross-functional departments to ensure effective communication and resolve key issues

Jul 2018 – Dec 2018 Project Coordinator, Camallergy Ltd:

• Cross-functional project coordination for the development of an oral, immunotherapeutic, peanut allergy treatment to successfully minimise peanut allergy in subjects
• Operations management of multiple, complex projects to enable preparations for Phase III clinical trials to ensure timely delivery from internal and external stakeholders, meeting quality requirements
• Translating technical, clinical and commercial strategies into project definitions and plans for successful project implementation
• Coordination with doctors and nurses in a specialist hospital clinic to the ensure the provision of a correct treatment regime for patients
• Coordination with a manufacturing facility to ensure the timely production and release of treatments for patients
• Coordination of vendor activities to enable the building of a GMP manufacturing site
• Coordination of a multi-site stability study programme to determine the quality of raw materials and products and ensure timely delivery of materials to required destinations
• Ensuring project requirements, risks and issues are identified and managed to ensure project success
• Ensuring the timely and detailed engagement of stakeholders, including clinical teams, CROs and Vendors to ensure strong and productive team-work contributing to project success
• Coordination of the preparation of timely and high-quality communications, submissions and protocols to instruct vendors in accordance with company plan and to distribute required information to all relevant stakeholders
• Documentation of company activities for essential traceability and regulatory requirements
• First point of contact for CROs, vendors, clinical teams, in-house professionals, suppliers and shippers to ensure all project aspects were performed to timelines and in alignment with project remit
• Coordinating analytical and technical trials for the development of standardised tests and process determination
• Stock management of in-house and externally held active ingredients, excipients and final products for analytical use, stability studies and patient treatment
• Weekly calls with CROs to check progress on project actions and to identify and mitigate risks
• Use of Asana, SharePoint, Google Docs and Accounting software, in addition to Microsoft programs for effective project coordination

Aug 2014 – April 2018 Science Officer/ Head of Microbiology, Bactest Ltd (company closed on 12th April 2018)

• Inventor of the patented, Speedy Breedy, one step test for Toxigenic Vibrio cholerae for worldwide distribution to serve an unmet diagnostic need
• Lab and Line Manager, maintaining the upkeep of an R&D Microbiology Lab, observing H&S practices and contributing to the Development and Sales of a Rapid Microbiology Product
• Managing research projects at Bactest and at contractor sites to ensure the successful and timely creation of required diagnostic, microbiological tests
• Developing new Rapid Microbiology tests for market
• Managing and writing scientific trials for customers and collaborators to enable successful R&D work for the creation of company products
• Writing SOPs and developing new working strategies for continuous improvement
• Carrying out scientific literature searches and research for Product Development
• Contributing to the writing of new Product data sheets and informational materials for customers
• Commissioning of certificates of analysis for products 
• Sourcing Contractor labs in the UK and internationally and writing Project Plans for implementation of company R&D at vendor establishments
• Providing specialist training on Lab practices and techniques to in-house Bactest employees and off-site contractor staff to enable effective use of company products
• Maintaining laboratory and product-related records to ensure traceability and to support technical files and Intellectual Property
• Providing prompt and informative responses to customer queries and the sales team, leading to effective company sales
• Attending conferences for product promotion and visiting customers and collaborators to provide product related information and to oversee developmental projects

Aug 2013 – Jul 2014 (contract) Translational Study Lead in Clinical Trials, Retroscreen Virology Ltd:

• Main point of contact for the Clinical Trial Sponsor, Quarantine Facility, Translational Lab, in-house Scientists, Auditors and Vendors to ensure apt translation of Sponsor requirements into a compliant plan for in-house lab staff
• Delivery of external viral challenge projects, GCP assay programmes for sample screening and analysis in Clinical Studies, using human viruses and cell cultures in accordance with the agreed protocol and timeline and in line with GCP standards
• Contributing to Clinical Study set-up, by preparing Agreements for Sponsor-approval, Study Documentation for Lab use and Data Transfers, in association with the Clinical Protocol
• Initiating and leading process improvements and initiatives to enhance the efficiency and quality of the laboratory work
• Ensuring samples were processed and assayed to a high quality within strict deadlines and budget availability
• Ensuring team proficiency by delivering training presentations on study-specific lab protocols, forms and laboratory techniques. 
• Shipment of samples in accordance with IATA regulations.
• Ensuring effective communication between all stakeholders, through the use of presentations and training for successful project delivery in line with Sponsor remit
• Successfully leading a team of Research Scientists and Assistants with project-specific direction
• Compiling data according to GCP practices and client remits, including QC of documentation in accordance with TMF requirements for clinical trials
• Compliance with Company standards, Policies, SOPs, HASAW and GCP and other applicable guidelines

Oct 2007 – June 2013 Research & Development Scientist (Microbiology), Phico Therapeutics Ltd:

• Investigating and developing the kill of MRSA, C. difficile and P.aeruginosa, using bacteriophages; providing reports and presentations on results and interpretations
• Supervising and training Microbiology assay operators
• Developing formulations for drug delivery
• Liaising with and training operators at external companies to troubleshoot assay complications with out-sourced projects
• Liaising with supplier companies to obtain new equipment and specific chemicals for project development

Nov 2005 – Aug 2007 Microbiology Supervisor, Baxter Healthcare Ltd., Thetford:

• Line-management and training of a team of three analysts for the Microbiological testing of sterile healthcare products, raw materials and in-process samples
• Overall successful day-to-day management of the Microbiology testing facility 
• Developing and implementing new testing projects and providing training for these           

Apr 2001 – Mar 2005  Microbiologist, Biotica Technology Ltd., Little Chesterford:

• Drug discovery using genetically modified microbes

Education

Feb 1996 – Sep 1997          M. Sc. (Merit) in Applied Microbiology, University of Westminster

Sep 1993 – July 1994         Postgraduate Certificate of Education for Secondary Schools (in Biology and General Science), St. Andrew’s College/ University of Glasgow

Oct 1989 – July 1993         B. Sc. Biological Sciences (Hons in Microbiology), University of Edinburgh