Clinical Trial Contract Manager (On-site/Hybrid)

Description

This role will be considered an "On-site/Hybrid" role, which means working from the Ridgefield, Connecticut site 2-3 times per week typically. 
 

The Clinical Trial Contract Manager is responsible for the preparation, negotiation, and administration of a variety of agreements assigned CDA/CTA contract development and negotiations. This role is responsible for the management of the day-to-day operations and oversight with third party contracting negotiator(s) as well as for supporting management goals and objectives of the department.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities

• Prepares, negotiates, and executes a variety of agreements (e.g., master services agreements, confidentiality agreements, Clinical trial agreements, etc.)
• Reviews contract language and prepares responses to negotiate contract modifications.
• Supports AD in more complex agreements.
• Maintains contract files and systems.
• Supports the implementation of contracting-specific and trial metrics and tools to report on, provide visibility into, and analyze performance and deliverables.
• Collaboration of third-party contracting negotiator (s) for successful support management of US clinical programs.
• Effectively uses evaluation tools and provide oversight over CRO/third party contracting negotiator (s) performance on trial negotiations to address performance issues and ensure high quality deliverables within planned timelines.
• Maintains a focused continuous improvement culture by identifying and executing strategies and priorities to enable the Contracting group to deliver value and enhance overall operational effectiveness.
• Actively remains current with industry standards, trends, and competitive intelligence on contracting best practices.
• Maintains close working relationship with all Clinical Operations as well as Legal, Ethics & Compliance and Clinical Development & Medical Affairs (CDMA).
• Manages the day-to-day operations and assists with oversight with CRO/third party contracting negotiator (s).
• Represents Contracting group for projects and working groups.
• Ensures commitment to customer-centric behaviors provides visibility to trial teams and broader Clinical Operations into ongoing work through up-to-date tracking.
• Maintains high degree of responsiveness to both internal and external requests.
• Resolves issues by working collaboratively across Clinical Operations and other groups within BI.
• Assists in delivering appropriate training for the Contracting group in partnership with the Training and Compliance group.

Requirements

• Bachelor’s degree from an accredited institution (preferred major/focus: Business/Health Sciences)
• Minimum of five (5) years of relevant experience in contract development and negotiations (preferably in regulated pharmaceuticals or healthcare industry or clinical operations).
• Extensive working knowledge and experience in contract environment, contract negotiation, investigator budgets and or/clinical finance and /or CRO management.
• Track record in setting priorities, organization and problem-solving skills which support and enable sound decision making.
• Excellent customer service skills and high attention to detail.
• Demonstrated analytical skills and critical thinking to resolve issues in a variety of complex situations requiring new solutions.
• Experience initiating and leading department and cross-functional strategic initiatives.
• Demonstrated experience in the regulated pharmaceutical or healthcare industry.
• Thorough understanding of all phases of drug development (I-IV).
• Understanding of federal regulations pertaining to IND and NDA regulations.

Eligibility Requirements:

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.

Desired Skills, Experience and Abilities

This position offers a base salary typically between $115,000 and $181,000.  The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements.  For an overview of our benefits please click here.