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, diversity and inclusion, 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 Director 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 Development & 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 lead department and cross-functional strategic initiatives.

　　Excellent written and verbal communication skills and the ability to be clear and concise in a variety of communication settings.

　　Ability to travel domestically as needed.

　　Ability to use and learn system applications, e.g., MS Office, document management systems, etc.

　　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.

　　Adherence to all relevant SOPs, regulatory policies and BI policies and procedures.

　　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.

　　Compensation

　　This position offers a base salary typically between $111,000 and $183,000.  The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements.

　　All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.