Job Details

  • Title: Contract Manager
  • Code: RCI-9505484
  • Location: East Hanover New Jersey (NJ) 07936
  • Posted Date: 11/08/2019
  • Duration: 5 Months
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  Job Description

Job Purpose :

  • The TM Senior Contract manager (CM) supports clinical research conducted by TM CS&I under the Institute for Biomedical Research (NIBR). 
  • Adhering to comapny guidelines and processes, the CM independently and efficiently negotiates and executes agreements as necessary to support Phase IIa clinical research including but not limited to confidentiality agreements, consulting agreements and clinical trial agreements with clinical trial sites including academic institutions.  
  • The CM also assists with training and onboarding of newly hired/ junior Contract Managers.
Major Activities :
  • Negotiation of clinical agreements as required for TM Phase IIa research (consulting, confidentiality and/or clinical conduct) ensuring that contract terms, budget, and payment schedules are within company approved guidelines, as applicable for each type of agreement.
  • Management of Consulting and Confidentiality Agreements as per departmental guidance including the use of Compliance Navigator for FMV rates for consultants.
  • For clinical trial conduct contracts (Clinical Trial Agreement (CTA) or Clinical Trial Request Form under a Master CTA), working with the clinical trial team (CTT), the CM creates a base budget using Grant Plan to negotiate a fair market value study budget and set negotiating parameters.
  • Works closely with the CTT to ensure that contracts are executed within the study timelines for study start up activities and within budget parameters or receives business approval for exceptional costs.
  • Responsible for negotiating the site contract language using the pre-approved alternative legal language (ACT manual) and in conjunction with NIBR legal and/or IP, Insurance, QA, Data Privacy, Finance, as necessary.
  • Final contracts are quality documents representative of company expectations and high standards.
  • Ensure that correct contract information is entered and current in OMS (TM contract database) including transparent status as contract progresses.
  • Responsible for frequent follow-ups with the other contracting party until contract is executed, and to document all follow up activities or other status changes in OMS. Expectations are for updated statuses at least every 10 days and more frequently as needed.
  • Lifecycle management of ongoing contracts managing amendments etc.
  • Finalize contract and process for signature though DocuSign in accordance with agreed department process.
  • Participates in work streams or other initiatives or collaborations as requested related to improving the contract and/or study start-up process.
  • Trains, onboard, and mentors newly hired or junior Contract Managers.

Key Performance Indicators :

  • Deliver high quality contracts (including budget) to agreed timelines and budget.
  • Accurate and consistent OMS status updates.
  • Successful management and prioritization of assignments to meet deliverables.
  • Successful onboarding and training of newly hired/junior contract manager demonstrated by the new contract manager’s

Education :

Bachelor’s degree in business administration, finance, science, nursing or related field.

Experience/Professional requirement :
  • Previous experience negotiating Confidentiality Agreements and/or involved in clinical study start up activities.
  • Previous experience in clinical trial operations that may have involved supporting contract management as a contract coordinator.
  • High degree of organizational, analytical, influencing and team management skills
  • Computer literacy with document and spreadsheet applications