Investigator Contracts Lead I

Investigator Contracts Lead - FSP (Site Contracts Lead)

Key Accountabilities: Contracting deliverables. Exercise good judgment in balanc...

Location

Australia

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities
Knowledge of the principles, concepts and theories in applicable business discipline
Experience in drafting and negotiation of Clinical Trial Agreements with clinical trial sites in a global operation preferred
Bachelor's Degree or equivalent and 5+ years of experience in clinical development operations or clinical trial outsourcing OR Juris Doctorate or equivalent and 2+ years of experience in clinical development operations or clinical trial outsourcing
Balance of general business, compliance, finance, legal, and drug development experience
Precise communications and presentation skills
Ability to plan, identify and mitigate risks to site contacting timelines
Ability to lead by influence rather than positional power to accomplish critical deliverables
Success in working in a highly matrix based organization
Fluency in written and spoken English is required

Job Responsibility

Lead study level site contracting activities, direct other ICL and act as primary study point of contract for site contracting issues and timelines on assigned studies
Partner with Legal and other divisions to manage escalations in the site budgeting and contracting space
Partner with Legal, Finance, pCRO and other divisions to identify and implement areas of improvement in the site contracting space
Applies acquired job skills and procedures to complete substantive assignments, projects and tasks of moderate scope and complexity in applicable discipline
Lead and develop relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interface
Collaborates with invoicing specialists and/or invoice service provider to ensure alignment with Investigative Site contracting and compensation requirements
Interacts with clinical site contracts & legal contacts, client and partner legal team, study management, site payments team, peer site contracting colleagues, CRO site contracting teams
Contributes to design, development and implementation of major business initiatives or special projects

At Parexel FSP, people make a difference. We have a key mission: to prevent and ...

Location

Spain

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

At least 3 years of experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities
Experience in drafting and negotiation of Clinical Trial Agreements with clinical trial sites in a global operation is preferred
Balance of general business, compliance, finance, legal, and drug development experience
Precise communications and presentation skills
Ability to plan, identify and mitigate risks to site contacting timelines
Ability to lead by influence rather than positional power to accomplish critical deliverables
Success in working in a highly matrix-based organization
Fluency in written and spoken English is required
Bachelor’s Degree or equivalent and 5+ years of experience in clinical development operations or clinical trial outsourcing OR Juris Doctorate or equivalent and 2+ years of experience in clinical development operations or clinical trial outsourcing

Job Responsibility

Responsible for direct site facing contract and budget negotiations through contract execution with assigned clinical investigator sites including initial agreements and amendments and oversight of other contracting professionals on assigned studies
Managing the Per-Subject Cost (PSC) process for assigned studies
Managing escalation and resolution for budget and non-legal term issues from other ICL or preferred Contract Research Organizations (pCRO)
Collaborating with other lines to plan site contracting timelines though start up
Exercise good judgment in balancing the risks to the sponsor in making budget and contractual decisions against the impacts to client clinical trial timelines
Follow processes to develop, negotiate, track, and execute global clinical study agreements with institutions and investigators participating in sponsored clinical trials
Work with partners to develop and oversee the global site budget process
Work with clinical trial sites and directly negotiate cost, business and contractual terms and conditions with investigators/institutions, making changes to contract templates within the Legal division approved parameters
Lead study level site contracting activities and act as primary study point of contact for site contracting issues and timelines on assigned studies
Partner with Legal and other divisions to manage escalations in the site budgeting and contracting space

Site Contracts Lead - FSP

The Investigator Contracts Lead is responsible for direct site facing contract a...

Location

Canada

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities
Knowledge of the principles, concepts and theories in applicable business discipline
Experience in drafting and negotiation of Clinical Trial Agreements with clinical trial sites in a global operation preferred
Bachelor’s Degree or equivalent and 5+ years of experience in clinical development operations or clinical trial outsourcing OR Juris Doctorate or equivalent and 2+ years of experience in clinical development operations or clinical trial outsourcing
Balance of general business, compliance, finance, legal, and drug development experience
Precise communications and presentation skills
Ability to plan, identify and mitigate risks to site contacting timelines
Ability to lead by influence rather than positional power to accomplish critical deliverables
Success in working in a highly matrix based organization
Fluency in written and spoken English is required

Job Responsibility

The Investigator Contracts Lead is responsible for direct site facing contract and budget negotiations through contract execution with assigned clinical investigator sites including initial agreements and amendments and oversight of other contracting professionals on assigned studies
Managing the Per-Subject Cost (PSC) process for assigned studies
Managing escalation and resolution for budget and non-legal term issues from other ICL or preferred Contract Research Organizations (pCRO)
Collaborating with other lines to plan site contracting timelines though start up
Contracting deliverables
Exercise good judgment in balancing the risks to the client in making budget and contractual decisions against the impacts to client clinical trial timelines
Follow client processes to develop, negotiate, track and execute global clinical study agreements with institutions and investigators participating in sponsored clinical trials
Work with partners to develop and oversee the global site budget process
Work with clinical trial sites and directly negotiate cost, business and contractual terms and conditions with investigators/institutions, making changes to contract templates within the Legal division approved parameters
Lead study level site contracting activities, direct other ICL and act as primary study point of contract for site contracting issues and timelines on assigned studies

Fulltime