Pharm-Olam International

  • Global Site Contract Associate

    Job Locations IN-Bangalore
    ID
    2018-1859
    Category
    Clinical - Admin
  • Overview

    Typically under the direction of a  Global Site Activation Sr. Manager , the  Global Site Contract Associate, assists with overseeing and manageing the contract and budget negotiation at study level, supporting the Local Site Activation Associate(s) and Global Site Budget Analyst(s) assigned during the start up phase.

     

    The Global Site Contract Associate will  work with Client Services, Legal, Business Development and Operations in the production and preparation of accurate, legally binding and effective Agreements that protect the interests of Pharm-Olam.

     

    As part of an ongoing contract management function, the Global Site Contract Associate will revise the text for site contracts after the specific out of scope of work has been identified by the Project Manager/Global Site Activation Manager and approved by the Client.

     

    The Global Site Contract Associate will manage contracts through Pharm-Olam’s internal approval process before these are sent to the Client.

     

    The Global Site Contract Associate will work with Legal  in providing regular review of contract documentation and in the update, review and development of new templates, processes and tools to assist in the contract processes and to ensure contracts are in compliance with Pharm-Olam policies and procedures.

    Responsibilities

    1. Responsible to attend the KOM and cover all aspects related the Clinical Trial Agreement(s) and budget negotiation process as well as discussion and completion of the CTA questionnaire.
    2. Responsible for the development of Clinical Trial Agreement and Budget Plan (CTABP) that must be signed prior 1st site is selected.
    3. Responsible for the coordination of Site Contracts & Budgets: will work alongside the Global Site Activation Manager and Global Site Budget Analyst to  oversee the negotiations of contracts and budgets with sites and internal team (Local Sites Activation Associates) according to the instructions agreed at the study level, and obtains  sponsor  approval on the Country-specific investigator budget draft including negotiation ranges and requirements for escalation.
    4. Responsible to provide sponsor with CTA questionnaire, general CTA template and fall back language.
    5. Responsible to provide Local Site Activation Associate(s) with approved CTA questionnaire, English general CTA template in track-changes and fall back language and incorporate into country templates, when using the Pharm-Olam contract template.
    6. Responsible to incorporate Sponsor changes into the draft Country CTA templates and have it reviewed and approved by the Local Site Activation Associate(s) and to obtain sponsor approval for the draft Country CTA template, when using the Pharm-Olam contract template.
    7. Responsible to review Sponsor template and fall back language provided by the sponsor at study level and share sponsor CTA template with the Local Site Activation Associate(s) for local revision, when using the Sponsor template.
    8. Responsible to get Draft Country CTA templates approved by sponsor, when using the Sponsor template.
    9. Accountable to develop Country-specific Site budget using GrantManager based on study specific procedures and perform an internal review Country specific Site budget from GrantManager.
    10. Responsible  for team training on CTA and Site Budget negotiation with the Global Site Budget Analyst.
    11. Responsible to get the final draft of CTA and site budget approval at site level
    12. Development and ongoing maintenance of templates and tools to assist in the management of the contract processes, e.g. template CDA, CTA .
    13. Participate in client contract negotiation, including group negotiation calls and direct client communication.
    14. Present at internal and/or external meetings Including Bid Defenses: prepare and deliver presentations in collaboration with relevant departments   
    15. Responsible for appropriate issue escalation program to appropriate stakeholder(s)

    Working relationships:

    1. Report directly to Global Site Activtion Sr. Manager at a project level
    2. Liaise extensively with Client Services, BD and Operations
    3. Communicate  with external clients as needed during the contracts negotiation process

    Qualifications

    • Good numerical skills
    • Paralegal certification preferred or equivalent contract review experience
    • Good computer skills with good working knowledge of a range of computer programs including CTMS systems.
    • Strong written and verbal communication skills
    • Some experience in negotiations
    • Good time management skills and attention to detail
    • Technical writing experience a plus
    • Experience working with cross-functional teams a plus
    • In lieu of the above requirements, candidates with 4 years prior experience with pricing and contracts desirable
    • Preferably some experience within the CRO/Pharmaceutical industry with an understanding of clinical trial processes

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed