Asha Nithianandan

Experience

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  YMCA Child Care

  Jun 2007 - Aug 2015

  Camp Counselor

  Work with about 50 children per day in the 9-12 age group and conducted activities in Lynchburg as well as trips outside of the city. Organized group games to work on team building and prepared crafts. Talked to parents about child’s behavior when necessary.

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  Alzheimers Association - Central and Western Virginia Chapter

  Jun 2014 - Aug 2015

  University Summer Intern

  Researched creative approaches to engage various stages of Alzheimer’s patients. Collaborated with several Walmarts in Virginia to gain volunteers for them in exchange for donations to Walk to End Alzheimer’s by gathering information and contacting each of them through phone or mail. Entered caregiver or patient information from Helpline into their database and assessed any further approaches to help them.

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  The Center for Diabetes Technology at UVa

  Aug 2014 - May 2016

  Clinical Trial Techinician

  Help set up the system and make sure the system is working properly; monitor the subjects while on the devices; stop the system and download devices, and data from remote monitoring system.

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  Social Behavior and Decision Making Lab

  Aug 2014 - Aug 2015

  Research Assistant

  Run 30-50 participants each week on various studies delegated by graduate students. Organize the data from each study in Google Sheets. Communicate with other RA’s to ensure that studies are run on time and error free.

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  DayWon, LLC

  May 2015 - Aug 2015

  Competitor and Marketplace Analyst Intern

  Working with an early stage startup that combines Gmail’s Contacts, Calendar events, and Tasks to enhance productivity. Performed competitive research analysis and gathered merger/acquisition information of 100+ companies in the CRM and productivity markets.

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  PRA Health Sciences

  Jun 2016 - Jun 2020

  -Act as liaison with client: Gain an understanding of client contractual, organizational, and relationship needs/expectations and assists in managing needs/expectations. Prepares and assists with reporting on client metrics, status of deliverables, and risks/issues with associated management plan to client. Knowledge of the overall Clinical Development Plan for the asset and how the project(s) fit within the client's final development and corporate objectives. -Management of project contractual deliverables: Develop the ability to identify risk and issues through review of project progress and metrics and suggest follow up actions to ensure adherence to the contractual agreement (time, quality/scope, and cost deliverables). Participates in presentation of internal project status reviews and assists with action items follow up. Proactively identifies , resolves/mitigates, and escalates risks and/or issues for assigned projects until resolution. Also functions as a point of escalation for project teams. -Management of project costs: Assist with projections of units/hours (revenue and resources) and actual units/hours efficiency analysis. Reviews project team resource allocations and make sure they are in line with budget and can achieve deliverables. Proactively and timely identifies and participates in the negotiations of contract modifications for assigned project(s), ensuring out of scope activities are approved upfront via a contract modifications. Identifies potential or actual unrecoverable hours and provides analysis and proposes mitigation/resolution plan. Participates in presentation of financial reviews and assists with action item follow up.-Supports cross-functional teams, leaders, and third parties/vendors: Contributes to development and maintenance of project plans. Supports team leads in troubleshooting and contingency planning. Understands the importance and impact of the project within the client's Clinical Development Plan. Show less -Organized project team and client meetings including scheduling, creating meeting materials, binders, agendas, and meeting minutes. -Supported preparation of study files by maintaining and distributing project documents. -Ensured documents within the electronic trial master file comply with filing/naming guidelines and have correct status. -Assumed project management tasks as assigned by PM/PD with final approval of deliverables completed by PM/PD.-Organized study information and supplies.-Managed internal and client project reporting. Generated and reviewed reports for accuracy to facilitate project status and financial reporting. Completed system updates and queries.-Supported PM with financial tasks. Oversight of purchase order process including creating and processing purchases. -Used learning management system to assign project specific training to team members and track training compliance. -Generated and maintained organizational charts, team calendar, newsletters, mass mailings, project specific information including but not limited to: process flow charts, contact lists, holiday lists, study website, and mailing labels. -Tracked, dispatched, and maintained study supplies following applicable company processes. Show less -Facilitated project financial reporting and administers vendor payments.-Compiled supporting documentation for project invoices to facilitate review and approval by the PM.-Developed and maintained project docs and communication tools including new team contact lists, organizational charts, team calendar, mass mailings, project specific flowcharts, websites, etc.-Managed client and internal project meetings: organized meetings, participant scheduling, booking resources, and preparing meeting materials, developing and distributing agendas, prepared and distributed meeting minutes. -Managed project status reports. -Generated and examined for accuracy internal project review materials prior to review by PM and facilitate input from project team. -Compiled client specific status reports and performed QC of said reports to ensure accuracy according to contract specifications. Show less

  • Associate Project Manager

    Aug 2019 - Jun 2020

  • Project Specialist I

    Apr 2018 - Aug 2019

  • Project Associate - Product Registration

    Jun 2016 - Apr 2018
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  WEP Clinical

  Jun 2020 - now

  ·Oversee and manage regional and global EAP projects.·Ensure all EAP programs’ project plans including timelines and budgets are developed, maintained, and in compliance with the Scope of Work (SOW).·Responsible for project team’s leadership, training, and operational oversight.·Responsible for building and maintaining positive client relationships.·Ability to negotiate with clients to assure WEP Clinical operational processes are maintained, and projects are delivered within scope.·Responsible for identifying, evaluating, monitoring, and mitigating any factors or processes that may threaten the quality of the project (i.e., risk management), as well as communicating identified risks to internal team members, upper-level management, and clients, as appropriate.·Develop, identify, define, and document study-specific training requirements to assure project-level compliance across EAP Programs.·Responsible for preparation and finalization of EAP Out of Scopes (OOS). This includes ensuring that Project Teams are identifying OOS effectively and developing the effective change orders in collaboration with WEP Clinical Business Development.·Responsible for assuring project teams are managing EAP programs in accordance with WEP Clinical SOPs and Policies.·Responsible for assuring project timelines are met as per contract.·Participate in proposal meetings for potential clients.·Review documentation for the Electronic Trial Master File required for Expanded Access Programs, including treatment guidelines, case report forms and completion guidelines, informed consent documents, investigator agreements, investigator brochures, logic checks and data handling guidelines, and other documents as required by the client.·In conjunction with management, assists with developing, documenting, and updating internal WEP Clinical procedures and processes required for consistency across programs such as SOPs, working practices, and related quality assurance forms. Show less •Manage the development, execution, and close-out of clinical research programs, including expanded access, managed access, and compassionate use programs. •Setup & close-out of the Electronic Trial Master File (eTMF), prepare study files based on project scope including maintenance of internal or external document storage systems.•Setup & close-out of the Clinical Trial Management System (CTMS), enter and maintain program, site, and patient-level data into the CTMS.•Conduct routine audits of document storage systems to ensure that regulatory documents are collected, updated, and filed appropriately.•Conduct routine audits of CTMS to ensure that data is accurate and up to date. •Senior oversight of the supply chain team to coordinate and dispatch shipments of investigational products according to WEP Clinical SOP’s. •Coordinate and lead internal and external teleconferences. •Execute project plans for new EAP programs. •Oversee the development of project-level documentation and CRF’s, ensuring updates are made as needed throughout the program. •Submit and perform central IRB applications. •Conduct weekly check ins with project team members.•Supervise, train, and mentor internal applicable project team members. •Provide protocol-related training to EAP investigators and site staff. •Oversee EAP program budget and scope of work to ensure on-time, on-budget performance and deliverables. •Review site invoices, process payments according to Clinical Study Agreement, and track payments.•Review and approve client invoice drafts provided by finance team to ensure accuracy. •Serve as the central point of contact for the EAP client and 3rd party vendors. •Plan, coordinate, and/or present at Kick Off Meetings •Assist drug safety team per the project specific safety management plan. •Review and approve monitoring trip reports as needed. •Liaise with Quality Assurance team to initiate and conduct program-related investigations, CAPAs, and audits. Show less • Accountable for the successful delivery of projects while demonstrating a high level of attention to detail• Manage interdisciplinary EAP programs, leading cross-functional teams to ensure on-time, on-budget performance and deliverables• Develop and execute project plans for new EAP programs• Serve as the central point of contact for the EAP client and all associated project vendors • Manage and coordinate drug shipments to EAP sites• Supervise, train, and mentor applicable staff• Provide protocol-related training to EAP investigators and site staff• Review and approve investigator study contracts and budgets• Review and approve regulatory and administrative documents from investigator sites• Assist in the development and/or review of EAP protocols• Review and approve Case Report Forms (CRFs)• Plan, coordinate, and/or present at Kick Off or Investigator Meetings• Coordinate and lead client teleconferences• Participate in proposal meetings with potential clients• Review Serious Adverse Event (SAE) reports• Manage third-party vendors, including review and approval of vendor invoices• Generate monthly client invoices• Perform IRB/IEC submissions• Prepare project management reports as needed for clients, project personnel, and WEP Clinical management• Review and approve monitoring trip reports as needed Show less • Assist with the development and execution of clinical research studies and programs• Assist with the coordination and planning of drug distribution to clinical sites. • Assist with the coordination and planning of drug inventory and warehouse shipping logistics• Enter data from forms and documents into the Clinical Trial Management System and prepare weekly reports from the database• Create Study File Notebooks and ship to study sites• Coordinate and track the collection, preparation and shipping of laboratory samples in compliance with research protocols• Track dissemination, receipt and approval status of study-related documents, lab kits, patient reimbursement items, and CRF binders • Order, track and maintain study supplies• Generate tracking spreadsheet to ensure required documents are collected from monitoring visits• Setup of the Electronic Trial Master File (eTMF), maintain study files and archive them• Setup of the Clinical Trial Management System (CTMS), enter and maintain study data within CTMS• Assist with the conduct of routine audits of clinical files to ensure that regulatory documents are collected, updated and filed appropriately• Coordinate mass mailings• Maintain the contact management database• Plan and coordinate internal study meeting agendas and minutes Show less

  • Senior Project Manager

    May 2023 - now

  • Project Manager II

    Jan 2022 - May 2023

  • Project Manager

    Jan 2021 - Jan 2022

  • Associate Project Manager

    Jun 2020 - Jan 2021