Arpita Dasgupta

About Arpita Dasgupta

Working in rapidly evolving Clinical Data Management Industry for over 20 years continues to be enriching for me. Talent management, contributing to the leadership, & working on development of CDM department are few of the key aspects of my current role. Accountable for ensuring that projects are conducted in a well-planned manner abiding by SOPs and processes. Any issue/risk are identified and mitigated on time to ensure CDM deliverables of high quality are successfully met per timelines. Accountable for ensuring project budgets are monitored on regular basis & financial health of the study is maintained. As part of leadership team, I contribute to ensure department’s financial targets are kept on track & achieved as set. Attending resource requests, working on RMT to ensure optimal utilization of resources. Involved in process improvement initiatives and cater to periodic review of CDM SOPs & WIs. Lead CSV team working with QA to complete validation of multiple systems. Part of team to regularly monitor and attend to any alerts, audit requirements, CAPA pertaining to CDM. Mentoring project leads in development of strategic planning & execution including Vendor management. Leading/implementing training & development plan of the department. As part of line management, responsible for development, performance, and growth of my team members which involves assessing their competencies, providing training/mentoring/coaching and share regular/timely feedback. Performance management & working towards retention of talents in the department. Accountable to ensure the department’s billability & compliance percentage are kept on track.Responsible for hiring for CDM positions in India coordinating with recruitment team, raising/approving hiring requests, screening profiles, conducting interviews, and closing hiring process within expected timelines. Responsible for hiring freshers, oversee the onboarding, induction, and trainings process to be completed on time.Point of contact for any internal escalation from senior members or any flags raised on data issues/ timelines. This further requires me to work independently with CDM team members, vendors, and cross-functional team members to address and resolve the issues. For assigned portfolio, I am the primary point of contact for any scoped CDM deliverables or issues. I am responsible and have contributed in building strong relationships with clients and to ensure customer satisfaction is enhanced which has resulted in repeat business.Strive to learn & grow in an Organization working towards its goals/targets.

Experience

1. Associate Director Cdm

   Quanticate

   Nov 2022 — Present · Bengaluru, IN

   Responsibility across the team for piloting and operationalizing solutions that leverage the combined strength of Organisation and Customers. Provide excellent levels of customer service and liaison and act as a key CRO representative for Clinical Data Management (CDM) activities in bid defence work. Contribute to growth of the business by identifying opportunities for new service offerings. Assist with business priorities and vision that CDM staff can translate into their roles. Drive continuous improvement in CDM processes by assessing the compliance, performance of the current processes and identifying root cause and needed improvements. Assist with resource and budget estimations for proposals in line with the CRO business model. Work with PDM/PM and implement process improvements. Ensure new processes and best practices are shared and adopted within the department. Assist with revenue prediction and recognition for the input of management accounts. Support the Head of CDM on quality, profitability, and service within CDM Lead development of process and metrics that will be used to evaluate the effectiveness of our programs and identify performance trends that indicate the need for process improvement. Support project management by mentoring and assisting the PDMs/PMs with project portfolio activities to ensure projects are delivered on time, within cost and of good quality. Support PDMs/PMs in the project kick off meetings to gain full understanding of project requirements and identify synergies. Identify and assess the risks and mitigate the risks to ensure they are not repeated across other studies by identifying root cause and bringing forth needed improvements. Periodic review of scope & budget, billability, utilization, KPI, compliance review, risk management, training and development Recruitment & People management: Direct reporting line of upto15 members with second level of dotted line reportee number varying between 40-60

Education

• Bangalore University

  Masters, Biotechnology

  2002 — 2004

Skills

• Clinical Data Management
• Oracle Clinical
• Mentoring
• Regulatory Requirements
• Crf Design
• Pharmacovigilance
• Ich-Gcp
• Eclinical
• Data Management
• Sae Reconciliation
• Edc
• Therapeutic Areas
• Ctms
• CRO
• Gcp
• Phase Forward Inform
• Pharmaceutical Industry
• Sop
• Line Management
• Standard Operating Procedure (Sop)
• Meddra
• Good Clinical Practice (Gcp)
• 21 Cfr Part 11
• Inform
• Electronic Data Capture (Edc)
• Data Validation
• Cdisc
• CRO Management
• Medical Coding
• Clinical Research