Dr. Monika Bahl Email & Phone Number

Medical professional with strong academic background, trained in human resource management, project planning and management with over 25 years’ experience in clinical research industry/ organizations. Significant experience of managing projects in varied therapeutic indications. Research experience spans over broad spectrum of responsibilities from clinical development program, grant writing, project planning, protocol designing, regulatory, operational & medical monitoring, data review and medical writing and overall project management for clinical trials, academic projects and research initiatives of national interest. Involved in training, managing mentoring and performance improvement of the team and quality management initiatives on individual, project and organization level. Assignment with Pharmaceutical companies has been a value addition in terms of strategic planning and operational execution of research activities and clinical trial management, resource utilization and forecast resource requirement to facilitate effective resource planning throughout the life of the product development, define project workloads and assignment and develop and oversee maintenance of internal databases and project plans. As Director- Clinical Portfolio Management with Clinical Development Services Agency an extramural center of THSTI (DBT, Govt. of India) has been leading the public health research portfolio in collaboration. with DBT, ICMR, academicians, SMEs, researchers and funding agencies, responsible for development of overall strategy, contribute to developing the clinical trials/studies portfolio including grant /medical writing, clinical operations and safety monitoring. Founder Director of ‘Shodh Clinicals Solutions’ and working as consultant and leading the clinical research programs and medical oversight for collaborative projects as senior advisor with CROs and Pharma companies. Technical experts with ICMR, BIRAC, SMEs, CROs and academic institutes, Technical advisory member for GC-PCS, IEC member and a visiting faculty to research organizations/institutes. Good understanding of the regulatory and operational processes/guidelines that govern the clinical research industry, working in collaboration with experts (industry, academicians, SMEs, public health professionals).Specialties: Clinical operations, Proposal & Grant writing, Clinical Research Project Planning and Management, Quality management and medical monitoring (Industry sponsored / Investigator's initiated / Public health research)

Listed skills include Clinical Trials, Ctms, Gcp, Cro, and 18 others.