Study and Site Operations Contracts and Payments Head (Remote Position)

Novartis

13d•Remote

About The Position

Overall responsible for the direction and management of the US Study and Site Operations (SSO) Contracts and Payment team. Responsible for the oversight and management of a team of Contracts, CDA and Finance for program and trials who negotiate contracts with clinical investigators participating in Novartis sponsored Phase I-IV studies. Oversee the work product of contracts, CDA and Program Finance managers and is accountable for the timely resolution of contract terms and budget issues. Negotiate Master Clinical Trial Agreements with key research institutions. Actively troubleshoots issues and defines solutions aimed at ensuring study start-up activities are performed timely and of high quality. Participates in and drives initiatives related to the Contracts, CDA and Program Finance Management process. Responsible for work allocation and oversight of milestone data entries contributing to key performance metrics. Works as a partner to Novartis Legal and Intellectual Property and participates in appropriate training with Legal partners. Participates, as the point person, in internal and external audits. Is the main point of contact for general questions related to the contracts management processes. This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 10% travel. LI-#Remote Job Description Key Responsibilities: Provides decisive leadership, vision and develops strategic plans for the team and ensures timely study start-up through investigator contract and budget negotiations/management. Key role in collaborating with US Legal, Ethics Risk and Compliance, Regulatory, QA, inventions and patents department to lead the resolution of complex contractual issues including subject injury, intellectual property, confidentiality, and compensation within the framework of the US legal and compliance requirements. Responsible to support and reporting of Key Performance Indicators to SSO SSU Country Head as they relate to advancing study start up contract metrics for all portfolios. Responsible for the direction and management of contracting for all types of agreements (Confidentiality Agreements, Task Orders, General Services, Agreements, Master Agreements, Site Agreement, Budget Negotiations and Assessments, Fair Market Value) for the US CO including the establishment of this function, training onboarding and oversight of contract and finance associates. Responsible for expanded support function related to contracting process including, establishing and managing a centralized contract Database, and a centralized team to review and establish fair market value for all projects within the department. Core role as compliance liaison: work closely with US compliance officer to ensure compliance with new regulatory and legal requirements, as well as establish best practices, responsible for strategic planning in this area, and proactively identifying areas of risk. Candidate supervises a staff consisting of Contract and Finance Managers as well as support staff and other roles. Candidate manages workload within group to meet anticipated timelines. Works closely with Senior and Executive Operations and Clinical Management teams to ensure timely execution of investigator contracts and streamlined efficient negotiations/management. Lead cross-functional focus groups, task forces and process improvement initiatives as required for the US contracts organization to share best practices with Global SSO and ensure cohesive standard procedures.

Requirements

Bachelor degree in finance, business or related field or equivalent work experience
A minimum of 5+ years’ experience in clinical trial operations, contract management and knowledge of the drug development process
The candidate must have a thorough understanding of clinical trial conduct and regulation.
Strong capability in working in a global/country matrixed environment.
Established track record of leading successful teams, preferably with experience in working with international teams.
Proven Strong leadership skills, strategic thinking skills and matrix management skills.
Strong interpersonal, negotiation and conflict resolution skills
Strong communicator and presenter (oral and written), ability to communicate to Sr. Leaders

Responsibilities

Provides decisive leadership, vision and develops strategic plans for the team and ensures timely study start-up through investigator contract and budget negotiations/management.
Key role in collaborating with US Legal, Ethics Risk and Compliance, Regulatory, QA, inventions and patents department to lead the resolution of complex contractual issues including subject injury, intellectual property, confidentiality, and compensation within the framework of the US legal and compliance requirements.
Responsible to support and reporting of Key Performance Indicators to SSO SSU Country Head as they relate to advancing study start up contract metrics for all portfolios.
Responsible for the direction and management of contracting for all types of agreements (Confidentiality Agreements, Task Orders, General Services, Agreements, Master Agreements, Site Agreement, Budget Negotiations and Assessments, Fair Market Value) for the US CO including the establishment of this function, training onboarding and oversight of contract and finance associates.
Responsible for expanded support function related to contracting process including, establishing and managing a centralized contract Database, and a centralized team to review and establish fair market value for all projects within the department.
Core role as compliance liaison: work closely with US compliance officer to ensure compliance with new regulatory and legal requirements, as well as establish best practices, responsible for strategic planning in this area, and proactively identifying areas of risk.
Candidate supervises a staff consisting of Contract and Finance Managers as well as support staff and other roles.
Candidate manages workload within group to meet anticipated timelines.
Works closely with Senior and Executive Operations and Clinical Management teams to ensure timely execution of investigator contracts and streamlined efficient negotiations/management.
Lead cross-functional focus groups, task forces and process improvement initiatives as required for the US contracts organization to share best practices with Global SSO and ensure cohesive standard procedures.