SUMMARY

• An enthusiastic, Program Management professional wif over 10 years of clinical research/ Pharma industry experience and 11 years of experience in Information Technology managing technically complex projects and possesses a forward - thinking approach to teh management of clients and assignments.
• Experienced leader in leading project delivery in a collaborative, constructive manner by complying wif structured project management methodologies, Project Management best practices and documentation practices. Blended experience of Clinical research and IT project management.
• 10 years of Clinical trial management experience at different roles such as in house CRA, Clinical project Manager, Clinical Supplies Manager, Clinical labeling and packaging specialist. Understands drug development cycle and different phases involved.

PROFESSIONAL EXPERIENCE

Confidential

Project Manager

Responsibilities:

• Move and support data movement from legacy GSK repositories to appropriate repository such as team sites, shared system area etc.
• Develop criteria for determining data compliance. Review data and take appropriate actions needed for compliance
• Documentation compliance - Currently working on Veeva vault enrichment (Veeva vault Quality solutions). Data migration from PIER to Veeva Vault (GxP compliance)
• Develop project plan, lead Project activities from requirement gathering involving data transfer from CRO, Clinical trial management software and other external sources, Data integration, and reporting for dashboard development. Data Visualization
• Lead Validation meetings involving documentation for GxP/Non GxP, and Testing engagement wif vendors
• Project Communication at all levels about Schedule/Risks/Issues/mitigations and Finance of teh project. Drive scheduled meetings wif Development team, Validation, CRO, Steering committee)
• Lead meetings wif Solution architect and informatica team for Data mapping/ Data modeling

Project/Program managemen

Confidential

Responsibilities:

• Work wif business analyst during initiate phase for business requirement document approval by business
• Work wif Portfolio team and business in preparing cost benefit Analysis and presenting it to finance for approval. Baseline teh cost post requirement specification documentation prior to design.
• Prepare project charter wif plan phase milestones and lead kick off meetings
• Prepare task order and get required legal, Finance, and business approval for WBS creation
• Work wif leadership team for resource planning using planning tool and forecast teh resources for operations team. Approve time sheets for project resources.
• Prepare weekly project activity report for executive attention wif issues and risks and provide mitigation
• Prepare project plan wif milestones and get an agreement from business
• Forecast Capex/Opex in finance tools and report teh financials on weekly basis
• Create change requests for change in cost, Schedule and Milestones as per PDLC definition.
• Monitor and drive towards approval of documents such as System requirement specification, System Design Document, Test strategy, test cases approval by business
• Monitor release management activity for teh scheduled releases and provide implementation plan in time. Keeping operational readiness checklist updated
• Present progress report in weekly status meetings. Work multiple streams of projects simultaneously
• Provide communication plan and drive project deliverables from plan to lessons learned.
• Worked as SME for clinical labeling module at Almac clinical services (GMP/GXP compliance) through NTT data at Pennsylvania USA as well as Craigavon, UK for a year in 2009 as part of ERP implementation (Oracle) Familiarity wif GXP documentation - 21 CFR Part 11.
• Worked as project manager for CareFusion Inc (Now Becton Dickinson ) for testing and validation engagement (2 years)
• Project manager for BMS (Bristol Myers Squibb) engagement for Computer System Validation (1 Year)
• Lead proposal development for Life science vertical / develop inhouse solutions (EX: SAP building blocks)

Testing

Confidential

Responsibilities:

• Responsible for establishing Test center of excellence and provide estimations for testing
• Project management: Establish project plans for teh different streams of testing and forecast resources, manage Risks/Issues.
• Provide weekly presentation to steering committee on progress
• Participate in CAB meetings for releases scheduled
• Resource, Time sheet management for teh account
• Work wif finance to have teh SOW reviewed and finalized.

Worked as Program / project manager

Confidential

Responsibilities:

• Manage resource allocation involved in project/Program as per Cost benefit Analysis sheet
• Work wif various departments (Business Analyst, Development, Testing, and Finance) and provide direction to keep teh projects in track.
• Monthly portfolio meeting wif CFO, business head and Portfolio managers/PMs.
• Classify projects based on portfolio and analyze each project based on strategic goals
• Ranking of projects under portfolio based on strategic goals
• Present Capex/Opex and align wif finance teams
• Budget and Resource forecasting presentation for investment committee for analysis
• Finance tools: Jaggaer for procurement, Adaptive for forecasting and SharePoint tools for resourcing.

Confidential

Manager

Responsibilities:

• Manage and lead Clinical Supply Documentation personnel
• Integrative forward-looking interactions and troubleshooting of projects and studies wifin teh TRD (Technical research and Development) network and customers in Clinical development
• Ensures compliance of label text and packaging instructions wif study protocol, country specific regulatory requirements and Technical research and Development requirements
• Optimize Clinical packaging documentation processes wif internal and external stakeholders
• Contributes and implements new systems and procedures
• Selects new staff members together wif superior(s) by conducting interviews
• Ensures appropriate planning of workload and resources
• Ensures adequate training of staff wifin his/her group
• Ensures compliance wif GMP Annex 13, GCP and other regulations

Associate Director

Confidential

Responsibilities:

• Building teh infrastructure needed to store Investigational medications as per GMP. (Good Manufacturing Practice) in different temperature zones.
• Ensure dat teh quality and integrity of all teh processes related to Clinical Trials Supply Chain Service Division during teh start-up of a Protocol are accomplished properly.
• Ensure dat all teh processes proposed by teh Customer and every Standard Operating Procedure (SOPs) are in accordance wif those actions and procedures performed at Depot.
• Assure teh accomplishment of established procedures during teh management of a Protocol.
• Liaise wif teh Global Technical Director of teh Clinical Trials Supply Chain Service Division, Depot Pharmacists, (Sponsors, Customers, Laboratories, Pharmaceutical Industries, CRAs, Clinical Investigators.
• Fulfill all teh requirements stated at teh Protocol’s Depot Project Instructions established by teh Customers/Sponsors and also in accordance wif SOPs.
• Maintain and assure compliance wif current ICH, GMP and FDA Good Clinical Practices, local regulatory affairs, legal Requirements and World Courier Standard Operating Procedures (or any other required).
• Compliance of Standard Operation Procedures which contents all teh specific instructions to develop each step, from teh reception to teh delivery of teh product concerned.
• Perform follow-up, identify and find out a solution for each Customer’s remark dat could appear during one’s Protocol Life.
• Conducting Feasibility study: To evaluate teh site capabilities and resources to conduct clinical trial and recommendation of teh site to teh sponsor. Conducted site qualification visit for teh trial.
• Regulatory submission for trials: To submit teh regulatory documents after compilation for teh approval of Drug controller general of India to conduct teh trial.

Confidential

Associate-Clinical Trial supplies and Site Management

Responsibilities:

• To maintain teh drug storage facility as per GMP and GCP requirements.
• Responsible for GMP Validation of teh facility
• Maintaining teh Investigational product at teh facility as per teh required environmental standards
• Involved in logistics management of drug distribution, Inventory management of Investigational product, keep a track of approved quantity of imported investigational product as per License.
• Management of IP, IVRS and logistics
• To assist clinical operations staff wif in-house activities related to teh conduct of clinical trials including document submission to teh site to conduct trial.
• Manage project documentation about each site for audit purposes. Keeping track of patient recruitment.
• FIBRIN GLUE Research projects. (Tissue sealant): Nature of job: Research, presentation, and journal references collection. Executive summary, exploratory work. Document preparation for regulatory clearances & multicentric clinical trails. Developed Investigator brochure for teh trial
• Trained at Novartis AG Basel, Switzerland in handling Clinicopia software for label design and randomization and Drug supply Management for 3 months.
• Communication for Managers- Dale Carnigi training at for 2 days
• Advanced learning Program for Managers- Negotiation skills, Conflict Management, Communication, Presentation Skills.
• Attended Training session in Buenos Aires, Argentina for 15 days on World courier Standard Operating Procedures
• Clinical Trial Supplies workshop