Rajashree Devarakonda, MBBS, M.Sc., CCRP, RAC(US/EU), EGMP

As Chief Scientific Officer (CSO) and a member of the Executive and Operations Committees, Raj is responsible for directing, leading, and ensuring the Consultancy team delivers high quality projects, and pre-project deliverables, bringing high value to the client and ultimately leading to a high level of client satisfaction.

By mentoring and coaching the Heads of Service Units globally, Raj is responsible for building an innovative and entrepreneurial culture within the team. She fosters a collaborative spirit between the technical and commercial teams, nurtures client relationships and ensures a seamless integration across all activities. Raj employs a common sense approach to delivering high performance, process efficiencies and quality improvement initiatives. She builds programs through collaboration with stakeholders focusing on talent management, to build high quality performance teams and overall improved company performance.

Raj has an extensive global experience in leading & developing operational responsibilities including strategic planning, resourcing, standards development, training, data management, CRO/vendor management, recruitment/retention within Drug Development, Patient Safety/PV, Regulatory & Medical Affairs.

Through her experience of directing a broad range of operations, Raj provides customers with leadership support in several areas: project delivery against key metrics, milestones & contractual obligations for a portfolio of projects to encompass KPIs and management in line with quality, time and financial expectations. She provides strong leadership, negotiation expertise, communication and business skills in concluding deals, liaison activities at a national & international level and has been integral to setting up many partnerships/alliances.

Raj is a Clinician with a strong clinical research & drug development background across various therapeutic areas with clinical contributions to more than 100+ clinical candidates-drugs, biologics, stem cells, gene therapy products, drug/device combinations. RAPS US/EU certified, CCRP certified, experience in global regulatory strategies, clinical development & Pharmacovigilance (PV) activities in multiple therapeutic areas. Strong experience medical/scientific review of the MAA/NDA modules, protocols, CSRs, IBs, gap analysis & due diligence. Sound knowledge of EU, US regulatory requirements, preparation of INDs, CTAs, NDAs, BLAs, MAAs & SA procedure, ODDs, PIPs. Raj holds various national, international, academic, clinical, managerial, and technical qualifications.