Contracts Associate and Budget Specialist at Pharmaceutical Research Associates, Inc. in Raleigh, North Carolina

Posted in Accounting 11 days ago.





Job Description:

Pharmaceutical Research Associates, Inc.

Contracts Associate and Budget Specialist

US-Remote


Job ID: 2021-84147
Type: US
# of Openings: 1
Category: Clinical Trial Management

Vertex Pharmaceuticals

Overview

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Who Are You?

You are an experience professional with a passion for clinical contract development and negotiation. You are organized, but flexible and adaptable to unexpected changes. You can easily envision the bigger picture, without losing sight of the day-to-day tasks. You can provide excellent leadership to not only your project teams, but also to clients. You are excited and enthusiastic. You motivate your teams to do great work and collaborate easily with your clients. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.

Still here? Good. Because if this is you, we’d really like to meet you.



Responsibilities

What will you be doing?

The Contracts Assocciate will be Responsible for the development and analysis of contractual relationships including investigator grants including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials. Provide support to the clinical team in the pricing, planning, execution and control of grants and contracts.

GENERAL POSITION SUMMARY:

The Site Contracting Rep works directly with clinical sites and legal on the negotiation of the Clinical Trial Agreement (CTA) and budget.

What do you need to have?

  • Ensures the successful negotiation and on-going management of clinical trial agreements with investigative sites.
  • Works cross functionally with Clinical Operations and Project Management in support of timely site start up for the conduct of clinical trials including accurate forecast of contract execution timelines.
  • Collaborates with the Functional Manager who will partner with other compliance departments to ensure country specific laws and regulations are followed to minimize risk in clinical trials.
  • Communicates and explains legal/ budgetary issues to internal and external parties per department guidelines.
  • Reviews and evaluates client requested contract changes and based upon department guidelines escalates deviations as appropriate.
  • In partnership with CTA Lead and others as necessary, evaluates priorities and quickly readjusts priorities with the changing needs of business and the client.
  • Identifies and proactively raises issues to the CTA Lead or CM, as appropriate, prior to their becoming critical or creates risk.
  • Appraises contracts for completeness and accuracy and ensures adherence to department guidelines; corrects documents and files changes to contracts.
  • Participates in client meetings for the purpose of expediting the contract signing process as directed.
  • Creates and maintains files for each contract.
  • Tracks all site interaction in data base in a timely and accurate manner and ensures that status updates are fully descriptive.

GENERAL RESPONSIBILITIES AND REQUIRED SKILLS

  • Refer to key responsibilities section below
  • Strong communication (written and verbal) skills to be able to interact with internal Vertex groups as well as external groups
  • Strong analytical capabilities
  • Intermediate presentation skills
  • Ability to work in a matrix, cross-functional team
  • Ability to understand, clearly articulate and defend company budget decisions and rationales
  • Thorough understanding of clinical trial budgeting process and ability to summarize high-level feedback
  • Ability to quickly ascertain and relay the needs of Investigative Sites/Site Staff and their Institutional requirements
  • Ability to quickly identify, communicate about and propose solutions for any site issues that may arise

KEY RESPONSIBILITIES:

  • Serve as primary point of contact with Investigative Sites for budget negotiations
  • Serve as primary point of contact between Legal and Investigative Site for the CTA language negotiations
  • Adhere to CBM policies and procedures for CTA and budget negotiations
  • Escalate budgets, as required, for fair market value assessments
  • Document all budget and contract activities in a tracking database and maintain milestone data
  • Liaise with Legal, Study Management, CBM and CRO (if applicable) to address and resolve site queries
  • Attend and contribute to study related meetings, as required
  • Keep Site Contracting Manager and study team members aware of urgent issues and status updates that may adversely impact study start up timelines
  • Manage site relationships to high standards of excellence



Qualifications

PREFERRED EDUCATION AND EXPERIENCE:

  • S. or Advanced Degree (or equivalent degree/experience in the opinion of the Hiring Manager)
  • Minimum of 5 years of relevant work experience


Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

PI149856472
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