Summary
Overview
Work History
Education
Skills
Timeline
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Sandra M. Dukes

Pottstown,PA

Summary

Pharmaceutical professional serving in the industry for 18+ years primarily in the area of Contracts - in both the Clinical and the CRO/Vendor/Sourcing capacities. Well versed at functioning and managing the deliverables and activities regarding the initial set up through the actual contract execution. Experienced with drafting, reviewing & redlining to also handling Master Service Agreements (MSAs), Requests for Information & Proposals (RFIs & RFPs), Work Orders (WOs), Change Orders (COs). Highlight skills include: creating study budgets via Grant Plan/Grant Manager, reviewing language and budget terms (Fair Market Value-FMV) and providing counter-proposals as per fallback provisions, processing site payments based upon contractual budget terms, working with systems such as SAP and ARIBA to that of being the primary contact, overseer, liaison and communicator of information concerning the project agreements in a fast-paced and ever-changing environment.

Overview

21
21
years of professional experience

Work History

Outsourcing Manager

Planet Pharma / Client: Astellas Pharmaceuticals
04.2022 - 03.2023
  • Communicated clearly with the suppliers and stakeholders to ensure all invested in the project are provided accurate contract status information
  • Served as the first line of contact of the Sourcing Category and Leads to process Master Service Agreements (MSAs), Work Orders (WOs), Change Orders (COs) and Amendments for the various Astellas projects
  • Defined clear targets and objectives and communicated this information to the respective team members
  • Worked closely with Clinical, Finance and Legal to obtain required reviews and approvals for the project agreements
  • Used industry practices, customer service skills and analytical abilities to resolve customer concerns and promote achievement of deliverable
  • Developed and maintained relationships with internal/external customers and suppliers
  • Able to work proficiently and meet designated timelines within a fast-paced and deadline-driven environment
  • Knowledge and displayed competency in utilizing ARIBA system
  • Understanding the order and flow of the sourcing process
  • Demonstrate willingness and desire to expand knowledge in learning other facets of the business.
  • Provided oversight of the contracting process
  • Able to work well independently with minimal supervision
  • Being able to re-focus and re-direct priorities as issues are presented
  • Display attention to details
  • Maintained 100% compliancy with the required Astellas SOPs and mandatory trainings
  • Excellent customer service and internal support

Sourcing Operations Manager (SOM)

Alpha Consulting / Client: Merck Pharmaceuticals
03.2021 - 04.2022
  • Provided support in the planning and start up activities of an Observational or Non-Interventional Research Study within CORE
  • Prepared and conducted Kick-off Meetings that highlight and showcase the services and define responsibilities of the SOM role
  • Established the existence of or initiated the process to secure one in place of the Confidentiality Agreements with identified vendors selected for consideration of the assigned project
  • Worked with the Study/Scientific Lead to ensure that activities, which may include preparation of the Request for Proposal (RFP), analyzing bid comparisons and review the scope of work with the corresponding budget are delivered timely
  • Research existence of or process new Confidentiality Agreement (CDA) in order to engage the sharing of information with potential supplier
  • Provided oversight in Fair Market Value analysis and/or different compliance activities
  • Liaised with members of Procurement and the internal CORE team work towards the goal of creating the purchase orders
  • Able to meet expectations concerning expected timeline deliverables
  • Demonstrated a sense of urgency and management of time in order to successfully meet the project goals
  • Excellent oral and written communication skills
  • Ability to demonstrate flexibility in order to meet the shift in project needs
  • Outstanding customer service skills with addressing internal and external business needs
  • Model Team player


Contract Review Manager/Sr. Paralegal

Amring Pharmaceuticals
03.2020 - 07.2020
  • Provided support to and assistance General Counsel
  • Served as the liaison to both internal and external stakeholders concerning licensing matters
  • Conferred with clients and other involved parties to gather and track license information
  • Provided oversight to Confidentiality Agreements and other Corporate documents statuses
  • Served as the main contact for contracting matters as well as overseeing Sourcing needs and managing Vendor Relations
  • Interfaced with leadership team members to gather topics and information for discussion for the monthly Leadership Team Meetings
  • Demonstrated excellent communication skills
  • Maintained compliance to all company mandated trainings and SOPs
  • Served as back-up to Executive Assistant

Outsourcing Manager

Alpha Consulting/ Client: Bristol Myers-Squibb
02.2019 - 02.2020
  • Provided oversight and guidance on the agreements for the vendor services of BMS Clinical Trials
  • Supported the Project Leads on the assigned Clinical Trials by serving as the point contact for all Sourcing and Contracting strategies
  • Provided timely updates to the Project Team regarding outsourcing statuses
  • Facilitated and led Kick-off Meetings that highlight the Outsourcing Manager's responsibilities, services and objectives to the Team as it relates to all pertinent agreements needed for the project
  • Successfully performed all duties and responsibilities providing oversight to all vendor contracts pursuant to FPFV deliverable
  • Demonstrated ability to manage the multiple projects and tasks simultaneously
  • Responsible for troubleshooting potential issues that put the expected timelines at risk
  • Performed research and entries into ARIBA system
  • Verified existence of Master Service Agreement with elected in order to initiate Work Order (WO)
  • Proven ability to work independently as well as within a team environment.

Budget Financial Analyst

Fox Chase Cancer Center (FCCC)
04.2018 - 02.2019
  • Responsible for financial and accounting processes related to clinical research activities within Business Operations of the Office of Clinical Research
  • Collaborated with FCCC colleagues to maintain targeted growth and future expectations
  • Developed clinical research budgets for Sponsored and Investigator Initiated trials
  • Actively participated in designated meetings to prepare for the Site Initiation Visits (SIVs)
  • Served as the functional area expert on all Vendor/ Sourcing and Contracting matters
  • Facilitated and led meetings that provided updates to the project in relation to budget matters
  • In charge of the budget negotiations with respective Sponsors or Clinical Research Organizations (CROs)
  • Conducted the review, and approval of the final language and budget terms of Clinical Trial Agreement on behalf of FCCC
  • Maintained compliance of all FCCC required training modules and SOPs
  • Excellent communication skills (oral and written)
  • Computer proficient and demonstrated knowledge of various internal system tools to perform role responsibilities
  • Outstanding team player

Budget/Payment Manager

ExecuPharm/ Client: Boehringer Engelheim (BI)
05.2016 - 10.2017
  • Responsible for reviewing protocols to create the trial budgets for the investigative sites participating in clinical trials
  • Displayed competency and proficiency in use of budget development tool, Grant Manager
  • Utilized Fair Market Value (FMV) standard as the basis to ensure that site budgets are within appropriate parameters
  • Provided oversight to the managing CROs assigned to various trials. Ensured Site Initiation Visits (SIVs) occurred in a timely manner
  • Processed site visit payments utilizing SAP and reviewing other vendor programming systems
  • Maintained 100% compliance with all required BI trainings and SOPs
  • Excellent oral and written communication skills

Sr. Site Contracts Associate

InVentiv Health/ Client: Glaxo Smith-Kline (GSK)
05.2014 - 04.2016
  • Assisted in the development of draft Investigator Study Agreements (ISAs) consistent with the standards set forth by GSK
  • Negotiated contractual language terms and the accompanying budgets with the participating investigative sites
  • Managed and provided oversight to the assigned Contract Research Organizations (CROs) by delivering the standards and expectations for the study
  • Worked closely with the internal and external stakeholders to ensure that the contracts are consistent with company standards and executed timely to ensure SIVs are conducted within the project timelines
  • Populated and maintained a tracking excel report (i.e. contract tracker)
  • Followed-through on all critical inter-departmental escalations to ensure the project deliverables were on target
  • Excellent written and verbal communication skills
  • Proactively engaged with the Study Team to provide contract status updates
  • Organized and lead meetings that would be necessary to address issues and concerns impacting contracts
  • Ability to handle multiple projects and agreements simultaneously with successful outcome
  • Excellent team member and customer service attributes

Contracts Analyst

BakerIT/ Client: Medtronic
07.2012 - 07.2013
  • Prepared draft Clinical Study Agreements (contracts and amendments) along with the assigned budgets
  • Responsible for reviewing language of the contractual and budgetary terms with the investigative sites to ensure that terms are based upon Sponsor standards
  • Conducted review of Informed Consents Forms (ICFs) to ensure that key sections are consistent with verbiage in the Clinical Trial Agreement (i.e. subject Injury and compensation, etc.)
  • Demonstrated the ability to prioritize and manage movement of the various contracts to ensure that finalization meets set expectations.
  • Managed and provided oversight to studies that were assigned to Contract Research Organizations (CROs)
  • Excellent communication and presenting skills
  • Successfully completed all Medtronic mandatory trainings and workshops specific for role
  • Demonstrated proficiency with computer knowledge and functionality
  • Model team player

Contract Paralegal

Coleman Nourian/Client: Actelion Clinical Research
04.2010 - 04.2012
  • Served as an the assistant to Actelion Sr. Counsel
  • Prepared and issued draft Clinical Trial Agreements (CTAs) to the investigative sites
  • Negotiated site budgets based upon the prescribed parameters set forth
  • Maintained spreadsheet and record relating to the contract status (i.e. tracker)
  • Review and negotiated language terms utilizing fallback and alternatives to counter propose
  • Responsible in handling escalation matters
  • Active participant in Study Team meetings and teleconferences to provide clarity and updates regarding the contract matters specific to the project
  • Served as liaison between attorney and site representative regarding contractual matters
  • Demonstrated ability to communicate and manage time effectively
  • Excellent team player and colleague

Contracts Administrator

Carrera Agency/Client: Abbott Vascular
07.2009 - 11.2009
  • Responsible for reviewing and negotiating language terms of the Clinical Trial Agreements for the sites selected for the study
  • Participated in weekly/bi-weekly legal departmental meetings to provide contract updates
  • Liaised with internal colleagues regarding the processes and procedures governed by Abbott Legal department
  • Provided, supported and assisted Corporate Counsel on various independent projects, as directed
  • Maintained 100% compliance of all mandated trainings and SOPs
  • Demonstrated excellent verbal and written communication skills
  • Successfully completed and performed various administrative tasks with minimal direction and supervision.
  • General computer competency

Contracts & Grants Analyst

RPS, Inc./Client: Johnson & Johnson (J&J)
02.2009 - 06.2009
  • Drafted, negotiated and finalized the Clinical Trial Agreements (CTAs) utilizing the parameters as set forth by Sponsor guidelines
  • Created and prepared draft budgets by reviewing the Time and Events Schedule using the oracle databases (Grant Plan/Grant Manager)
  • Interfaced with legal to ensure contract language modifications are within the accepted terms of Sponsor
  • Worked closely with the Study Teams to ensure that specific site budgets are within prescribed & approved budgetary terms
  • Attended regular team meetings and teleconferences to highlight progress of the site contract status information
  • Displayed ability to perform duties independently with minimal supervision
  • Excellent communication skills- verbal and written
  • Compliant of all company SOPs and trainings
  • Outstanding support and team player

Contract Negotiator

ClinForce/Client: Roche Pharmaceuticals
04.2007 - 11.2008
  • Liaised with different departments to coordinate information and data gathering for contract development
  • Responsible for issuing draft Clinical Trial Agreements (CTAs) as prepared for the various investigative sites
  • Negotiated specific site budgets based upon the prescribed parameters set forth
  • Maintained and updated internal excel document relating to contract status information
  • Attended Study Team meetings to provide contract status updates
  • Displayed ability to successfully perform responsibilities independently as well as within group/team environment
  • Able to work under strict time guidelines
  • Outstanding communicating skills
  • Reduced grievances and arbitration needs by educating frontline managers on techniques for enhancing interactions between labor and leadership.

Associate Clinical Agreement Manager

AstraZeneca Pharmaceuticals
01.2002 - 04.2007
  • Responsible for the drafting and finalizing of Confidential Disclosure Agreements (CDAs) ensuring that the final terms are consistent with Sponsor standards
  • Prepared and issued draft Clinical Study Agreements (CSAs) and budgets to the participating sites
  • Created study budgets utilizing AZP3 and other Grant Plan
  • Reviewed the proposed redlines to language and budget terms as submitted by the respective site for Sponsor counter review and feedback
  • Demonstrated ability to handle and manage 75-80 agreements at a given time
  • Participated in Departmental and Study Team meeting sharing best practices and offering ways and solutions to typical business needs
  • Possess ability to work efficiently as well as effectively to provide quality support and meet time deliverables.
  • Excellent customer service qualities
  • Active listener and attentive to the needs of the Study Team as the progress of the contract status impacts deliverables
  • Successfully managing multiple tasks and assignments simultaneously

Education

Bachelor of Science - Paralegal Studies

Widener University - Legal Education Institute
Wilmington, DE
08.2002

Skills

  • Contract Development, Review and Management
  • Customer Relationship Management (Internal/External Stakeholders)
  • Verbal and Written Communication
  • Time Management
  • Administration and Status Reporting
  • Negotiation
  • Timelines and Milestones
  • Detail-oriented

Timeline

Outsourcing Manager

Planet Pharma / Client: Astellas Pharmaceuticals
04.2022 - 03.2023

Sourcing Operations Manager (SOM)

Alpha Consulting / Client: Merck Pharmaceuticals
03.2021 - 04.2022

Contract Review Manager/Sr. Paralegal

Amring Pharmaceuticals
03.2020 - 07.2020

Outsourcing Manager

Alpha Consulting/ Client: Bristol Myers-Squibb
02.2019 - 02.2020

Budget Financial Analyst

Fox Chase Cancer Center (FCCC)
04.2018 - 02.2019

Budget/Payment Manager

ExecuPharm/ Client: Boehringer Engelheim (BI)
05.2016 - 10.2017

Sr. Site Contracts Associate

InVentiv Health/ Client: Glaxo Smith-Kline (GSK)
05.2014 - 04.2016

Contracts Analyst

BakerIT/ Client: Medtronic
07.2012 - 07.2013

Contract Paralegal

Coleman Nourian/Client: Actelion Clinical Research
04.2010 - 04.2012

Contracts Administrator

Carrera Agency/Client: Abbott Vascular
07.2009 - 11.2009

Contracts & Grants Analyst

RPS, Inc./Client: Johnson & Johnson (J&J)
02.2009 - 06.2009

Contract Negotiator

ClinForce/Client: Roche Pharmaceuticals
04.2007 - 11.2008

Associate Clinical Agreement Manager

AstraZeneca Pharmaceuticals
01.2002 - 04.2007

Bachelor of Science - Paralegal Studies

Widener University - Legal Education Institute

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Sandra M. Dukes