Vandana Bhise

Current Roles and Responsibilities as ‘Engagement Delivery Lead’ are listed below:

Project Management:

Managing a Team of 50+ associates to ensure overall project deliverables are met.

· Driving Innovation/Ideation within the team to ensure Margin optimization targets are met.

· Contributing as one of the key stakeholder in finalization of Service Level Agreement /KPI target.

· Identifying measures of cost reduction opportunities/to avoid revenue leakage, implementing them

· Planning and implementation of ‘new technology practices’ such as internal knowledge sharing portals, Information Security practices, automated production metric generation etc. to enhance process efficiency & cost effectiveness.

· Oversee overall billing and invoicing of the account

· Govern planning of resource / infrastructure requirements (like workspace, delivery location expansion)

· Key contributions in managing all major internal and external audit review of audit findings and take corrective action to prevent similar incidents in future.

· Risk and Issue Management.

· Client Relationship Management

· Key Contribution in Project Extension/amendment/renewals

· Reviewing the forecast/cost and reporting deviations on monthly basis.

· Liaise between higher management and Operations team member to establish the healthy work environment

· Ensure readiness for BCP, Ensure Safety of team members, Productivity and Utilization when BCP is invoked

· Discussion on operations challenges with Client on regular basis and through meetings like Alliance meetings, OSC and ESC.

Knowledge Management:

· Driven Best Practices within the team few examples are. Implementation of Study complexity calculator, Migration calculator, and KPI performance calculator

· Consistently achieving yearly targets of Lean projects , which is helping to improve TAT and Quality of overall deliverables

People/Team Management:

· Addressing all queries and feedback arising from team to ensure those are managed efficiently

· Working on appropriate mentoring/coaching and grooming of direct reports to move on to the next level

· Overseeing of roles, responsibilities and accountability of each team member within teams; take necessary measures to control attrition

· Conducting “Town-halls and R&R” to acknowledge the contribution and achievements

Few of the Key Significant Achievement in this role are as below:

· Completed ‘Digify Me’ Certification

· Received ‘ Zenith’ Award for significant contribution in Contract Renewal ,wherein the Bid was won at the highest rates across all the projects

• Service Delivery Manager:
• Few of the key roles and responsibilities managed in this role are as below:
• Contract Management and Client Management
• · Point of contact for Data Management Project Leads for initiation of new service orders & additional scope of activities.
• · Managing client Communicate Master Service Agreement / Scope of Work updates
• · Participate in defining strategies for new processes and technology at either regional or global level
• · Provide operational input into proposals and scope of work. Provide input to costing algorithms \ Clarify, manage and successfully implement customer expectations, resolving conflicts whilst pursuing win-win scenarios
• · Ensure deliverables are negotiated as per contractual agreements and provide strategic inputs to business
• Resource Management and Team Management
• · Resource mapping and resource utilization is managed across project to ensure smooth delivery of all milestones
• · Responsible for resource deployment, leadership, supervision and management oversight for onsite members.
• · Develops charters, resource utilization and project plans to achieve functional area specific goals
• · Accountable for the implementation of group activities including Study Startup, Data Acquisition, Safety
• Therapeutic Area Lead
• · Experienced in managing Respiratory, cardiovascular and Infectious Disease studies in TA Lead Role
• Few of the Key responsibilities managed in this role are as below:
• · Accountable for all CDM study deliverables for a particular TA Liaise with Client counterpart for regular portfolio connects
• · Collaborate with DMTL for regular study activities, manage on time delivery of all studies milestone Participate in Protocol trainings for all studies, and help team with protocol understanding
• · Ensure work carried out by DM providers is in accordance with applicable SOPs and working practices
• · Efficient coordination in decision-making role with support teams like EDC Build Team, DMPT, Coding, Labs, EDF, external vendors etc.
• · Actively lead the standardization streams for the respective TA, which includes process improvement initiatives, implementation of best practices and ensure knowledge management across the TA
• · Coach associates, work towards creating strong resource pool within the Therapeutic Area Analyze study metrics, ensure data cleaning is performed as agreed in DRP (Data review plan) for all studies within a portfolio .
• Create/Review CAPAs, and ensure implementation and prevention of redundant defects.
• · Perform CAPA effectiveness along with DMTL. Ensure compliance and audit readiness amongst team members
• · Contribute to the development and implementation of processes and training for data management function
• · Analyze the results from quality control activities (e.g., metrics, discrepancy analysis, data audits) to ensure that data quality is managed
• · Hold formal project reviews with management to ensure successful project execution and customer satisfaction at TA level
• · Provide oversight for overall study budgeting, billing and forecasting to ensure alignment and avoid gaps or revenue leakages
• · Review KPI data for accuracy before it is shared with KPI POC .Review NSW activities highlighted by the DMTL/Functional group
• · Effective project management, tracking and monitoring of risks and study level metrics. Highlight risks in Mainspring/FMEA on timely basis and ensure closure of the same.
• · Escalation Management to ensure all escalation at TA Level are managed/addressed within required TAT to enusre client satisfaction
• Few of the Key Significant Achievement in this role are as below:
• · Key Contributions in building the training material for external and internal training materials.
• · Building and Implementation of Complexity calculator, which helped in ensuring studies are billed based on the study complexities/efforts and duration of the study .
• This project was greatly acknowledged across all projects within Cognizant and was released as’ Best Practices’ at Organization level
• · Awarded with ‘Data Management Excellence Award’ by client for managing Transition of studies ‘Transition Manager’

• Few of the Key responsibilities managed in this role are as below:
• · As a Team Manger have worked primarily as ‘Program Manager’ on one of the Imp Oncology Molecule.
• · There were 9 studies running under this Program’ which were successfully delivered with the team of 25 + associates from Final Protocol- First Subject In-Final Database Lock
• · Audit management, Resource planning and utilization, Risk and issue management, Program management, Finance management, Inter-team coordination, Volume management and attrition handling, Participation in strategic meeting with clients.
• Key accomplishment during this period are as below:
• · Successfully managed the role of ‘Program Manager’, received multiple appreciation/awards for managing this role with client delight
• · Completed Green Belt Project certification -Set up Quality FTR
• · Certified as Idea champion in Innovation program for the year 2014.

Team Leader:

Few of the Key responsibilities managed in this role are as below:

· SDTM Mapping (Interpret Medical Meaning)

· Delivery of study Interpret document for data harmonization

· Served as a single POC for delivery of Interpret Medical Meaning Team

· External and internal audit participation

· Productivity and Quality management

· Participation in strategic client meetings and discussions.

· Creation of specifications and user-friendly functionality enhancements for various tools like MLCS, Medical Meaning, Colocate, SASDD.Interpret Loading

· Interpret Medical Meaning Team was built from the scratch, managed hiring, training and mentoring of 10+ Team members within a span of 3 months

Significant Achievements in this role:

· Managed team of 10 + team members successfully by delivering multiple stringent timelines.

· Managed peaks and Troughs of the project significantly well which was recognized by appreciation, awards and promotion to the level of Team Manager within 2 years period.

Team Leader (Data Management)

Few of the Key responsibilities managed in this role are as below:

· Worked on end to end data management activities on various platforms like Rave, Inform, OC RDC

· Handling study Migrations, Third part reconciliations, Serious Adverse Event Reconciliation

· Creating and building Manual checks for the study

· Updating Lab reference ranges in the system

· Query Management (raising, closing queries)

· Reviewing the forms entered by the site and data entry personnel

· Creating reports, graphs for presenting study status/analysis in different meetings

· Data cleaning, data freezing and data locking activities

· Coordinate overall data management activities by serving as a primary point of contact for the sponsor, external data providers and all project team members

· Ensure project timelines are met according to agree upon timelines with high quality

· Timely issue escalation to internal and external stakeholders

· Responsible for tracking various data management activities using the study reports

· Ensure proper handover is taken in case of study Transition

Significant Accomplishments during this Tenure:

· Single handedly managed DBL for phase 2 Asthma study with 150 subjects

· Performed Quality assurance and Quality control activities on 5 studies which had successful locks

· Certified trainer in various applications such as CRFDEN, SPOLA, Crystal reports and Paper process flow.

· Certified trainer in RECIST.

· Worked on automated CRF tracker and successfully implemented across projects this automation was nominated in an internal Innovation initiatives session

· Promoted in May 2009 From Data Manager to Team leader within 2 years span in recognition of significant contribution in multiple study deliveries

Few of the Key responsibilities managed in this role are as below:

· Worked on Set up and conduct activities in Rave and InForm

· Handling Migration

· Handling Third Party Reconciliations

· Creating and updating documents required for set up and conduct activities

· Creating and building manual checks for study

· Updating Lab reference ranges in the system

· Raising and closing queries

· Review forms entered by site and data entry personnel

· Creating reports and preparing graphs

· Responsible for loading, extracting and validation of client data and monitoring all data for accuracy

· Performing data system checks, manual checks, data auditing

· Creating fortnightly trackers for maintaining status of study

· Data Cleaning, Data Freezing and Locking of data

Significant Accomplishments during this Tenure:

· Achieved a target of cleaning 6000 pages in two months (April and May 2008) with high quality data, which was very well appreciated by Client and was recognized by 'WOW' award internally

· As a Primary Data Manager managed to deliver successful Data base lock of EDC study within 6 weeks for 450 subjects

· As a Primary Data Manager managed to deliver successful Database lock for a Phase 4 with 200 patients within a period of two months

· Promoted in May 2009 from Data Manager to Team leader within a span of 2 years in recognition of significant contribution in multiple study deliveries

Worked as a ‘Product Execute’ in Glenmark's Diabetology and Cardiovascular Division ' Healtheon'

Few of the Key responsibilities managed in this role are as below:

Persuading potential customers to purchase company medications, identifying prospective business opportunities, providing the relevant departments with customer feedback.

In the later phase of this role, key responsibilities were to observe and trap competitor prices, campaigns, new product launch. Provide hands on support to new joiners.

Contributed to design the unique specific campaigns to take or achieve maximum market share and help to penetrate in the market

Attended various seminars, camps, conference for promoting the products

Achieved Quarterly sales target for the assigned regions

Significant Accomplishment in this Role:

Awarded multiple times for achieving the highest sale of Insulin Range during the product launch Period

Awarded multiple times for over achieving the sales

Awarded multiple times for client relationships which helped in achieving the targets very smoothly for the assigned regions

Awarded multiple times for client relationships which helped in achieving the targets very smoothly for the assigned regions