● Over 13 years (including 6 years in the USA) experience as a clinical research professional with demonstrated expertise in global clinical development especially in decentralised clinical trials (DCTs). ● Strong leadership, team management, and communication skills, with analytical/strategic problem solving and decision-making abilities in challenging, matrix-driven environments, with strict adherence to organizational goals, timelines, and professional integrity.● Experience and expertise in the following: o Early- and late-phase development (Phase I to IV)o Analysis/evaluation and identification of trends in scientific (clinical/safety) datasets for investigational drugs to articulate their Target Product Profile (TPP) and devise clinical strategies.o Design clinical studies, preparation/review of study protocols, study documents and clinical sections of regulatory submission materials. o Handling of various eTMF, CTMS platforms and EDC platforms.o Collaboration with internal/external stakeholders, including Investigators (PIs, SMEs, KOLs) on study design and conduct.o Communication with regulatory agencies to address concerns/queries on clinical submissions.● Clinical Project/Program Management experience handling studies from start-up to close-out, including all aspects of financial, lifecycle, vendor and stakeholder management.● Experience in handling and successfully completing multiple Regulatory inspections (USFDA), Sponsor and in-house audits.● Sound knowledge of ICH-GCP guidelines and Health Agency (USFDA/EU) guidelines/regulations ● Therapeutic area expertise: Oncology, Hematology (including rare diseases such as Chronic neutropenia and Sickle Cell Disease), Neurology (including the rare disease – Fabry disease) and Neuropsychiatry, Gastroenterology, Endocrinology, Genitourinary, Respiratory, Ophthalmology, Cardiovascular, Dermatology, Musculoskeletal, Anti-Allergy and Infertility.
Listed skills include Clinical Research, Transmission Electron Microscopy, Program Management, Clinical Trials, and 7 others.
