Smita Pandit Email & Phone Number

Hyderabad, Telangana, India

Greater Hyderabad Area

Hyderabad Area, India

Hyderabad Area, India

Joined as Director and was promoted to the position of Senior Director in Nov’2014• Headed the project managers and data managers’ team in APAC region for global client’s deliverable. Undertake the full range of duties relevant to the leadership, management and development of the team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives • Responsible for oversight and growth of Functional Group P&L • Provide oversight and support for regulatory and client audits • Leads and oversees standardization of program operations and deliverables. Serve as a repository of study issues, best practices and communication between ancillary groups • Lead the development and revision of Operational SOPs, Work Instructions, Forms and Templates in compliance with regulations and Good Clinical Practices • Participate in the business development process for division including capabilities presentations, bid defenses, and proposal development. Attend industry conferences through topic presentations • Serve as a Portfolio Owner for key strategic client accounts, support Client Account Management and participate as PAREXEL representative for Strategic Account Management initiatives • Identification and development of third party relationships to support growth opportunities • Liaise globally with Senior Directors\Directors –Operations to ensure harmonization across all locations. Represent Ops for key client Executive Steering Committee or Governance Meetings • Ongoing review of competitive losses to identify service offering gaps. Ongoing review of customer satisfaction scores and comments to evaluate for service or operational gaps • Assists staff with long-term career development. Supports and facilitates the training needs of the functional groups to include all required training

Hyderabad Area, India

• Reporting of clinical data manager’s team and taking accountability for the full range of data management services on multiple global projects. Team size-20, responsible for on time deliverables within quality and budget. Plan and manage resources across the projects/reportees, including active involvement in interviewing, retention and absence issues. Ensure that staff utilization and productivity expectations are met. Ensure the appropriate type and skill level of personnel are assigned• Provide support and mentoring to staff on acceptable DM procedures, processes and concepts to ensure the highest standards of quality, productivity, planning, client service and compliance are achieved. Provide input into improving Data Management Standards and participation in continuous process / productivity improvement• Contribute to project bids, cooperate and support the counterparts in other locations• Provide accurate forecasting figures for the annual budget and manage P&L throughout the year to ensure that the budgetary goals are met or exceeded. • Participate in the formal review processes e.g. performance and salary reviews to corporate standards and timescales

Hyderabad Area, India

Worked in Life science and Healthcare vertical includes the areas of Clinical Data Management and Pharmacovigilance. With partnership alliance dealing in Clinical trial operation area managing the Project Manager, Senior Project Manager and overseeing projects of IT and pharma domain to execute service delivery. Help sales teams and account management for Life Sciences and Medical Device companies in new business proposals and winning strategy. Provide industry domain expertise to re-invent HCL’s Life Sciences offerings and brand in the market place. • Won four projects in one year duration and expanded in Asia Pacific region• Ensure deliverables within budgetary constraints, developing strategic business development plans. Resource management, recruit, develop, manage & responsible for their appraisal (direct reporters). Managing the virtual teams and clients with regular online and teleconferences and frequent travel and ensure team is trained, motivated and coached appropriately. P & L responsibilities to track operations.• Participate in partnership & alliance with the customer DM and S/W application, implementation and support groups. Understand and comply with all the SOPs, policies and guidelines• Support new business opportunities and develop client specific strategies.Deliver presentations and proposals, negotiate and deliver contracts.

Hyderabad Area, India

• Reporting of clinical data manager’s team and taking accountability for the full range of data management services on multiple global projects. Team size-20, responsible for on time deliverables within quality and budget. Plan and manage resources across the projects/reportees, including active involvement in interviewing, retention and absence issues. Ensure that staff utilization and productivity expectations are met. Ensure the appropriate type and skill level of personnel are assigned• Provide support and mentoring to staff on acceptable DM procedures, processes and concepts to ensure the highest standards of quality, productivity, planning, client service and compliance are achieved. Provide input into improving Data Management Standards and participation in continuous process / productivity improvement• Contribute to project bids, cooperate and support the counterparts in other locations• Provide accurate forecasting figures for the annual budget and manage P&L throughout the year to ensure that the budgetary goals are met or exceeded. • Participate in the formal review processes e.g. performance and salary reviews to corporate standards and timescales

Mumbai Area, India

As a departmental head, plays a key role in strategy and team building, apart from the crucial role of coordination with clinical operations, technology and business development.• Supervision of all CDM operations and development of strategies in alignment with quality, effective and timely deliverables. Maintain a regional role within the Biostatistician and Medical Report Writing department. • Act as a liaison with clients. Led RFP initiatives, budget and forecasting• Responsible to establish/monitor annual budget and resource requirements. Support the establishment of training programs for CDM staff .Perform annual evaluations, while ensuring the execution of corporate goals • Standardize aspects , development and review of policies, SOPs and associated documents. • Work jointly with Business Development & Project Management to assess feasibility & scope of new projects. • Involved in standardizing and streamlining the process by giving input to the IT vendor for change management and System Development.

Mumbai Area, India

Joined as Biometrician and was promoted to the Senior Biometrician in Feb 2003Involved in Strategic/ Policy and operational aspects • Involved in the delivery of study implementation services according to SLAs and promote the use of consistent, efficient and quality processes to meet timelines and deliverables for the site based project teams according to specifications. Create, maintain and assume accountability for a culture of high customer service• Perform randomization, CRF design and database design activities and develop edit check and data derivation procedures to support the implementation of new clinical trials for all Dev Ops sites. All GCDS study implementation activities are conducted in compliance with relevant regulatory requirements using agreed standards such as GRADES. Participate in implementation of applicable WW initiatives• Formulate the Data Quality Management Plan (DQMP) and track its metrics. Data cleanup and finalization of database prior to generation of SAS Tables and Reporting. • Review of paper case report forms (CRFs) , query management to improve the data quality, edit check programming & running , database audit as QC step and manage laboratory data followed by break-blind run• Regulatory Reporting of standard safety tables and listings. Validating/verifying the study report and Annual Report tables. • Providing feedback to the clinical team on the design of protocol and CRF, CRF – filling guidelines and in defining database structure. Continuous feedback on data issues which included feedback to the clinical team and supporting groups, provided ad-hoc data listings as and when needed and contributed to investigators and other project meetings.• Worked on various Pfizer proprietary application and industry standard tools

Bachelor'S Degree, Science, A

Master'S Degree, Chemistry, A