Clinical Trial Contract Manager
- Compensation
- Not disclosed
- Location
- Not listed
- Work setup
- Not specified
- Seniority
- Not specified
- Employment
- Contract
- Experience
- Not specified
- Category
- Legal
- Posted
Skills
Must have
- Bachelor’s degree from an accredited institution (preferred major/focus: Business/Health Sciences or other related education)
- 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 site operations.
- 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.
- General understanding of drug development.
- Understanding of federal regulations pertaining to IND and NDA regulations.
- Adherence to all relevant SOPs, regulatory policies and BI policies and procedures.
Full description
Description
The Clinical Trial Contract Manager is responsible for leading the negotiation, execution, and management of clinical trial agreements and site budgets that support the successful delivery of U.S. clinical studies. This role partners cross-functionally with Clinical Operations, Legal, Ethics & Compliance, and external stakeholders to drive efficient contracting processes, ensure high-quality outcomes, and support continuous improvement across clinical development programs.
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
- Review and negotiate site budget in adherence with defined parameters and processes.
- 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.
- 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 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).
- 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.