Heather Worthington, Mba

Heather Worthington, Mba Email and Phone Number

Director, Feasibility Strategy at PPD @ PPD
wilmington, north carolina, united states
Heather Worthington, Mba's Location
Greenville, North Carolina, United States, United States
Heather Worthington, Mba's Contact Details

Heather Worthington, Mba personal email

About Heather Worthington, Mba

Heather Worthington, Mba is a Director, Feasibility Strategy at PPD at PPD. She possess expertise in ctms, clinical trials, clinical research, cro, gcp and 16 more skills.

Heather Worthington, Mba's Current Company Details
PPD

Ppd

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Director, Feasibility Strategy at PPD
wilmington, north carolina, united states
Website:
ppdi.com
Employees:
20768
Heather Worthington, Mba Work Experience Details
  • Ppd
    Director, Feasibility Strategy
    Ppd Oct 2023 - Present
  • Ppd
    Associate Director, Feasibility Strategy
    Ppd Sep 2021 - Oct 2023
  • Ppd
    Feasibility Strategist
    Ppd Sep 2018 - Sep 2021
    • Participates in Site ID assessments by setting initial strategy at the time of the RFP and through discussions with the client and cross functional team members, creating site assessment surveys, overseeing creation of optimal site profile and site list development, reviewing data from sites, determining parameters for tiering sites and providing PSV recommendations. • Conducts data mining of internal and external databases to develop robust strategies for conducting clinical trials and makes recommendations for geographical placement (country/site mix). • Oversees all feasibility service offerings and works with team members to identify risks and develop mitigation plans, oversees project finances, and provides cost estimates for OOS work. • Serves as the feasibility lead for Strategic and/or Alliance Partners. • Leads cross functional teams to coordinate Trial Optimization efforts and is accountable for final report deliverable and presentation to the client. • Serves as functional bidder for all multiple service and stand-alone RFPs; prepares/oversees preparation of the budget and text for proposals for which strategic feasibility is included. • Develops innovative tools for enhancing strategy and participates in initiatives to create efficient and effective ways of conducting feasibility assessments and identifying the best sites for studies. • Leads/participates in intra and inter-departmental meetings, presenting information on strategic feasibility offerings, demonstrating continued value-add of the department and providing training on best practices, processes and tools.
  • Ppd
    Senior Feasibility Specialist
    Ppd Apr 2013 - Mar 2014
    Wilmington, North Carolina Area
    Leads the gathering and consolidation of key information from investigators, in determining whether the patient population and investigator availability will support PPD in its ability to perform a given clinical trial.• Manages the feasibility process within Feasibility Services to ensure consistency and quality of data• Ensures all applicable privacy legislation and PPD Privacy Policy and relevant SOPs/WPDs are followed• Provides expertise and guidance in the management of complex feasibility assessments• Coordinates the execution of feasibility studies• Assists with preparing formal feasibility reports (including any required narratives) for client presentations• Assists with identifying potential protocol enrollment risks as well as appropriate country and site selection• Participates, as requested, in clinical intelligence gathering initiatives• Supports an accurate and comprehensive database of investigators• Assists clinical management to expedite feasibility, site selection and study start up• Participates in process improvement initiatives for Feasibility Services.• Provides guidance and mentoring to junior team members, as appropriate.• Supervises and provides work direction for temporary staff as necessary.• Undertakes training and mentoring of new and junior team members in feasibility processes and conduct.• Provides oversight and guidance to Feasibility Services team during the conduct of complex feasibility assessments.• Assists with additional department objectives and process improvement initiatives.
  • Ppd
    Feasibility Specialist
    Ppd Oct 2010 - Mar 2013
    Wilmington, North Carolina Area
    • Perform analytical and administrative responsibilities to support thesuccessful completion of feasibility and site identification deliverables.• Manage the oversight of feasibility activities and coordinate with global country representatives to encourage successful completion of feasibility activity and identify potential risks or concerns • Coordinate the execution of feasibility studies and site prioritization activity and interact with global clinical and project management teams• Contribute to the delivery of feasibility reports and site recommendations which are provided as client deliverables, and also serve to assist PPD in understanding potential therapeutic and delivery enrollment challenges and to win new business• Participate, as requested, in clinical intelligence gathering initiatives as alternatives to survey-driven feasibility assessments• Assist Clinical Management to expedite feasibility, site selection and study start-up;• Ensure all privacy legislation and policies are followed• Participate in process improvement initiatives for Feasibility & Site Identification
  • Ppd
    Research Coordination Specialist
    Ppd Apr 2009 - Oct 2010
    Wilmington, North Carolina Area
    •Recipient of PPD Peak Performance Team Award: January 2010•Review regulatory documents for proper content in accordance with FDA, ICH/GCPs, PPD and client company appropriate SOPs prior to submission to the Project Manager, central IRB, Regulatory Affairs and/or the client•Develop and maintain assigned data points within the CTMS database according to the established conventions and tools for the project, within specified timelines•Develop study-specific training materials such as templates, study file notebooks, site support and training materials•Train and mentor clinical administration team members regarding the regulatory document review process•Implementing and maintaining a Learning Management System (LMS)•Collaborate with other functional groups to assist them with any process or study questions•Correspond regularly with investigators, team members and sponsors on various project related issues•Coordinates between project staff, investigators, and sponsor to help ensure all project tasks meet deadlines •Accountable for meeting applicable project timelines in accordance with the contract•Mentor the research and project teams in the preparation and execution of all clinical administration functions
  • Ppd
    Project Assistant
    Ppd Nov 2007 - Apr 2009
    Wilmington, North Carolina Area

Heather Worthington, Mba Skills

Ctms Clinical Trials Clinical Research Cro Gcp Regulatory Affairs Ich Gcp Sop Pharmaceutical Industry Management Fda Edc Clinical Development Clinical Monitoring Oracle Clinical Therapeutic Areas Microsoft Office Clinical Data Management Customer Service Budgets Cross Functional Team Leadership

Heather Worthington, Mba Education Details

Frequently Asked Questions about Heather Worthington, Mba

What company does Heather Worthington, Mba work for?

Heather Worthington, Mba works for Ppd

What is Heather Worthington, Mba's role at the current company?

Heather Worthington, Mba's current role is Director, Feasibility Strategy at PPD.

What is Heather Worthington, Mba's email address?

Heather Worthington, Mba's email address is he****@****ail.com

What schools did Heather Worthington, Mba attend?

Heather Worthington, Mba attended East Carolina University - College Of Business, University Of North Carolina At Wilmington.

What skills is Heather Worthington, Mba known for?

Heather Worthington, Mba has skills like Ctms, Clinical Trials, Clinical Research, Cro, Gcp, Regulatory Affairs, Ich Gcp, Sop, Pharmaceutical Industry, Management, Fda, Edc.

Who are Heather Worthington, Mba's colleagues?

Heather Worthington, Mba's colleagues are Maud Meunier, Chris Seaton, Lisa Hitchcock, Dana Weaver, Kimberly Schofield, Thomas Wells, Angela Macdonald.

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