Arti Mansute

About Arti Mansute

Goal To achieve a meaningful and challenging position that allows me to apply my technical knowledge & experiences gained from past services along with skills of managing people, tasks and client/customer-interface for organizational growth and self development. Professional Summary With 16+ years of Clinical Operations experience, doing project management for clinical studies in US, EMEA, LATAM and APAC countries (phase II, and IV studies) for more than 5 years now. Have comprehensive understanding of GCP, clinical trial design, regulatory processes and global clinical development process; Qualitative experience in clinical project management, collaboration with business development, vendor selection and management, risk assessment, CAPA management, inspection preparation activities, local onboarding and consultation and local regulatory intelligence. Along with project management, perform an assertive leadership role with customer and internal teams to ensure scope adherence & change control throughout execution of the project. Explore & execute productivity initiatives for efficient management of allocated resources. First hand Clinical experience in Chest Physiotherapy, Orthopaedic Physiotherapy, Pre & Post Operative Physiotherapy, Intensive Care Unit (I.C.U.), Coronary Care Unit (C.C.U.), Medical Indoor and outdoor with Neurology, Paediatric, Obstetric and Gynaecology, Rheumatology, Plastic Surgery, Hand and Burn Rehabilitation. Specialties: An effective communicator with strong analytical, problem solving and organizational abilities; possess a flexible and detail oriented attitude; can work independently, lead a multidisciplinary trial team in a complex matrix environment. Have good leadership, negotiation and project management skills with strong customer oriented mindset.

Experience

1. Centralized Monitoring Manager

   IQVIA

   Aug 2022 — Present · New Delhi, IN

   Provide leadership of the centralized monitoring team, in partnership with project and clinical lead, and in collaboration with other functional teams, to achieve the delivery of the project’s overall objectives to the sponsor’s satisfaction per contract while optimizing speed, quality and cost of delivery and in accordance with our standard operating procedures, policies and practices. With particular focus on leading/advising the centralized team (centralized monitors and centralized monitoring assistants) towards solutions to clinical risks identified and facilitating successful implementation of those strategies to address the issues. Facilitate efficient and effective review of Site Visit Reports and assure consistent standards of implementation for quality to meet or exceed quality standards. Ensure subject safety, data integrity, escalation of issues and timely and responsive feedback in compliance with IQVIA standard operating procedures, ICH-GCP guidelines, protocol requirements and regulatory compliance. To provide expert support in the Centralized monitoring studies from Applications/ Analytics/ Therapeutics/ Quality perspective.

Education

• IBAM, Kolkata

  BASM, Alternative Medicine [Accupressure]

  2001 — 2002

• Meerut University

  BPT, Medical Sciences

  2001 — 2005

• KHMS

  Schooling, All

  1986 — 2000