Senior Project Manager Resume

SUMMARY

Over 20+ years of experience across multiple industries, with 16 years focused exclusively on life sciences, I bridge the gap between IT and PV
Overall Project Manager for large - scale projects including Safety Signals identification and management, data migration and ARGUS implementation projects. Used Agile methods and processes to manage the implementation.
Experience with all phases of SDLC cycle
Relationship manager with CRO’s and vendors. Hands-on experience in resolving issues with ARISg and ARGUS
Proficient in writing Business Requirements, Test Plans and UAT testing
RFI, RFP, PV Vendor selection and Transition activities
PVA agreements and contracts. Negotiated contracts with CRO’s and vendors
Experience with both Safety and Clinical data
Business Continuity and Disaster Recovery Specialist. Certified in Business Continuity.
Extensive knowledge of BI tools including Hyperion, Business Objects and Cognos
Extensive knowledge using Microsoft tools, including MS Project, Excel, PowerPoint and SharePoint

PROFESSIONAL EXPERIENCE

Senior Project Manager

Confidential

Responsibilities:

Overall Project manager for implementation of a new ICSR system using PPD as the vendor in ARGUS 8.1.2. Led all the work streams including case processing, medical review and IT. Used Agile methodology to implement the system.
Vendor management including contracts and contract negotiations in both Safety and Clinical data with CRO’s
Global hands-on management of issues after ARGUS implementation
Extensive use of MS Project, PowerPoint, Excel and SharePoint

Senior Consultant

Confidential, Bridgewater, NJ

Responsibilities:

Senior technical lead for US-based analytics development team supporting Oracle AERS
Business analysis and requirements verification supporting PV/safety system requests
Development of PV/Safety regulatory-analytic reports, custom requests in Oracle DB utilizing baseline templates, custom SQL queries, and Business Objects
Mentoring to junior developers
Change control management and impact analysis

Technical Consultant

Confidential, Edison, NJ

Responsibilities:

Administrator for ARGUS Safety, ARGUS Insight and Spot Fire applications
Provided guidance and support to the business users for the above applications. This included answering user questions, doing change controls and making sure a proper impact analysis is done for all issues

Senior Consultant

Confidential

Responsibilities:

Successfully wrote and got approval on a Business Continuity Submission Job Aid for Biogen. This involved working with the Biogen Submissions team and gathering information on ALL regulatory agencies for the document. Presented to top management.
Designed and deployed surveys to all Allergan Affiliates to identify local and systemic risks. Collected and analyzed responses, included sending out reminders to achieve full participation. This process was done for 3 separate surveys - Pharmacovigilance, Medical Information and Healthcare Compliance. Reviewed PVA agreements with the affiliates.
Reviewed and commented on 30 + SOP’s for the Glenmark Argus Safety and Argus Insight project. This involved SOP’s from Oracle, Sciformix, Glenmark and Navitas. Wrote five Integrated SOP’s to incorporate multiple stakeholders’ SOP’s.
Reviewed RFP for Argus Implementation project for ARIAD. Helped in shaping and preparing the proposal. Presented the proposal to ARIAD top management
Presented Business Continuity Planning findings and insights to a global network of PV technology specialists in London and New York

Senior Project Manager

Confidential

Responsibilities:

Managed the implementation of ARGUS 7.0.4 in Santen. This included ARGUS Safety and Insight. This involved integrating three databases into one, This was a CLOUD based solution using the SaaS model. Used Agile methodology to implement the system.
Data migration required both E2B and manual data migration. This was a global database implementation and included EU and the US.
This system successfully went live on November 11, 2014 within six months of initiation
Managed the whole process from RFI, RFP, Vendor Selection and negotiation and finally overseeing the implementation of the system
Involved in review and writing PVA agreements with vendors
Also participated and oversaw UAT testing. Conducted Smoke Testing on ARISg and ARGUS system
Acted as Relationship Manager for both the old (ARISg) and new (Argus), to make sure the system was functioning smoothly
Supported the DSSS/PM in EU/US Drug Safety database working group
Served as Database Super-user to contribute to and support creation of global drug safety database validation, implementation, training, strategy and ongoing global use
Assisted with creation and implementation of Drug Safety operational processes and tracking systems
Created Business Impact Analysis (BIA) document for the Drug Safety Group