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Contract and Budget Analyst 
Ref No.: 18-50346
Location: Wilmington, Delaware
Start Date / End Date: 10/01/2018 to 09/16/2019
Job Description:
Job Title: Contract and Budget Analyst 
Job ID: 18-50346
Location: Wilmington, DE
Duration: 12 Months

Job Summary
A managing position p
roviding leadership during the clinical agreement and site level budget negotiation process to ensure ethical, fair and compliant practices are followed when developing, negotiating and executing clinical agreements and investigator budgets. This position necessitates providing leadership, direction, and guidance through process improvement, interactive communication and stakeholder management. This role requires a high level of interactive communication to set clear direction for the study teams and external Institutions. 
Major responsibilities 
 
  • Develop and negotiate investigator budgets based on Fair Market Value. Leverage historical data, negotiation techniques, and address SoC with sites to realize cost savings. 
  • Negotiate agreement language with investigator study sites to reach a shared understanding of deliverables, a timely study start-up and financial obligations. 
  • Be responsible for producing clinical investigator budget appropriate Payment Schedules based on the Protocol and policy and guidelines to provide to Clinical Delivery Team. 
  • Formulate and identify the proper agreement template to initiate negotiations. 
  • Act as point of contact and interface with Legal if necessary to ensure integrity of contracts. 
  • Drive site start-up time by striving to execute CSA within KPI. For each study, maintain the status of all study agreements, budgets, issues, and communications with both internal and external sources. Attend and engage in scheduled project team meetings. 
  • Ensure final contract documents are consistent with agreements reached at negotiations. 
  • Support internal and external audits and litigation activities. 
  • Negotiate appropriate terms and conditions of Informed Consent Forms, Investigator Sponsored Agreements and other Clinical Agreements and associated documents. 
  • Approve Clinical Study Agreements with final signature, according to Delegation of Authority. 
  • Negotiate a variety of common contractual issues related to standard template agreements. 
  • Process amendments to contracts, as necessary, and manage that modification. 
  • Work with study teams to determine priorities for meeting timelines and SIV dates. 
  • Serve as a liaison between the legal and clinical trial teams. 
  • Negotiate master templates with preferred or notable Institutions. 
  • As a subject matter expert, exhibits contract and negotiation expertise to achieve a balance between external business exposure and policies/regulations.
  • As a subject matter expert, demonstrates an understanding of how contractual terms add value to internal and external customers. 
  • As a subject matter expert, possesses detailed and in-depth knowledge of contract precepts, the contracting process and budget development. 
  • Demonstrate a strong understanding of how the contracting and budget processes contribute to Project Management practices (schedule/cost forecasting and risk management). 
  • Demonstrate accurate knowledge of regulations and policies in order to maintain and develop the effectiveness of the Clinical Study Agreement & Grant Management processes. 
  • Ensure compliance with client’s Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment). 
     
Additional Responsibilities May Include 
 
  • Ensure timely customization and completion of the CSA for designated studies. 
  • Participate in training and mentoring of new members of the local Study Delivery Team ensuring compliance with ICH/GCP and Procedural documents. 
  • Ensure that all study documents are ready for final archiving and sign-off completion of the local part of the Trial Master File. 
  • Contribute to process improvements, knowledge transfer and best practice sharing. 
 
Minimum Requirements and Preferred Background
 
  • Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification. 
  • Post-graduate training in contracts administration or work experience as a paralegal in 
    pharmaceutical or health care industry. 
  • Experienced user of FMV tool, specifically MEDIDATA Grant Manager tool. 
  • Five years’ experience in pharmaceutical or health care industry, or seven to ten years of experience as paralegal or contractor administrator in pharmaceutical industry. 
  • Knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP. 
  • Good knowledge of relevant local regulations. Good medical knowledge in relevant Therapeutic Areas. Basic understanding of the drug development process. 
  • Good understanding of Clinical Study Management including monitoring, study drug handling and data management. 
  • Ability to travel nationally as required. 
 
Please note: Manager would also be open to someone with 2-3 years exp. looking for a self-starter, high energy, customer service oriented person who is also adaptable to technology.


Please apply on our company website (www.artechinfo.com) with reference to job ID, or contact me at nisha.samuel@artechinfo.com / 973.967.3540
 
Thanks,
Nisha Samuel
Assistant Manager- Staffing

Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.967.3540 | Fax: 973.998.2599
Email:nisha.samuel@artechinfo.com| Website:
www.artech.com
Artech is the #1 Largest Women-Owned IT Staffing Company in the US!

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