Site Contracts Lead Job at iconplc

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

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

Investigator Contracts Lead/Site Contracts Lead

Contracting deliverables: Exercise good judgment in balancing the risks to the c...

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
Fluency in written and spoken English is required

Job Responsibility

Contracting deliverables
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
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
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
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

Site Contracts Associate I - FSP

The Site Contract Associate I (“SCA”) is responsible for negotiation with sites,...

Location

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

1-4 years of experience in site contracting or combination with a related field within the CRO industry
Bachelor's degree in a related field (e.g., law, economics, business, social sciences), equivalent training or industry experience
Solid working proficiency of all MS Office Products specifically, Excel, Word, and PowerPoint
Possess strong negotiation, diplomacy, and excellent organizational skills with demonstrated experience handling multiple projects
Excellent interpersonal, verbal and written communication skills
Strong problem-solving skills
Ability to successfully work in a 'virtual' team environment
Must have strong analytical skills with the ability to create or interpret legal language and budgets
Maintain grace under pressure while displaying a high level of professionalism
Align internal and external resources to achieve objectives

Job Responsibility

Draft, review and negotiate all site agreements including but not limited to clinical study agreements, service agreements, team member agreements and other types of related documents like letters, notices, etc
Provide context to comments received from sites in light of local legal and business framework, common practices, and past negotiation experience for the purpose of further review up the decisioning chain
Apply and scrutinize site contract and related documents and their revisions against negotiation and budget parameters (as applicable)
Ensure final documents comply with applicable laws, regulations, and guidelines, including ICH – GCP
Ensure the best interest of both clients and Parexel are met
Serves as key communication liaison between site contracts staff and internal and external customers
Manage the contract execution process, including obtaining required signatures and ensuring timely execution of the document by all parties
Follow record maintenance and archival guidelines to ensure they are met
Develop and maintain positive relationships with clinical trial sites
Develop and maintain a thorough understanding of the clinical trial protocol, budget, and timelines to ensure that contract terms align with the overall trial goals and objectives

Fulltime

Investigator Contracts Lead I

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

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
Partner with Legal, Finance, pCRO and other divisions to identify and implement areas of improvement in the site contracting space
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, and CRO site contracting teams

What we offer

Premium salary
Attractive benefits
Medical care plan: Health, Dental & Vision
Life Assurance
Excellent work environment
Culture of teamwork and collaboration
People who motivate and face challenges together
Innovative technology
Excellent training

Senior Analyst, Site Contracts & Budgets

Parexel FSP is hiring a Senior Analyst, Site Contracts & Budgets in Argentina. T...

Location

Argentina

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Three to five years or experience in the pharmaceutical or biotechnology industry in clinical site contracts and/or outsourcing management
Proficient with Excel and PowerPoint
Excellent verbal, written and interpersonal communication skills in a dynamic and growing organization
Willingness to learn international clinical pharmaceutical standards, ICH/GCP guidelines and regulatory compliance issues
Strong interest in learning more about contracts and budgeting in support of Sponsor clinical trials
Working knowledge of clinical trial functions, including clinical operations, regulatory and drug safety
Ability to prioritize and manage multiple tasks simultaneously
Some limited travel may be required

Job Responsibility

Negotiate and maintain Clinical Trials Agreements (CTA), site budgets, Confidential Disclosure Agreements, Consultant Agreements, and other applicable contracts
As required, oversee CRO or Functional Service Provider in the development of clinical site budgets and partner with clinical operations to ensure budgets are in line with study protocols
Ensures compliance of contracts with Fair Market Value (FMV) principles and guidelines
Track contract progress, complete required follow-ups and coordinate the timely completion of clinical sites contracts
Oversee CRO and Functional Service Provider activities in regards to site CDAs
Collaborate and coordinate with cross-functional teams
R&D, Legal, Compliance, Procurement and Finance in executing contracts
Develop, maintain, and analyze tools and systems (spreadsheets, Smartsheet, databases, etc.) to manage contract lifecycle from initiation through contract execution, and build internal metadata to support accurate reporting
Provide guidance and direction to new clinical operations and/or outsourcing team members and R&D teams on site contracts & budgets processes
Provide accurate progress updates to Clinical Operations teams on all outstanding contracts and budgets

What we offer

Benefits vary by country, but Parexel is passionate about our team’s overall wellness
flexible working options

Fulltime

Investigator Contracts Lead I - FSP

Parexel FSP is looking for multiple Investigator Contracts Lead I (ICL I) in Bra...

Location

Argentina

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

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
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

Job Responsibility

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

Fulltime

Senior Site Contracts Negotiator

We are currently seeking a Senior Site Contracts Negotiator to join our diverse ...

Location

Bulgaria , Sofia, Warsaw, Bucharest

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in law, business, life sciences, or a related field, or equivalent experience
Significant experience in site contracting or clinical vendor contracting within CRO, pharma, or a related industry
Strong understanding of clinical trial agreements, budget structures, and key legal and compliance considerations
Excellent negotiation and communication skills, with the ability to balance site, sponsor, and organisational needs
Highly organised and detail-oriented, with experience managing multiple contracts and timelines across countries
Solution-focused mindset, with the ability to manage escalation situations and contribute to process improvements

Job Responsibility

Leading the negotiation of site contracts and budgets for complex or high-priority clinical studies across multiple countries
Reviewing contract terms to ensure alignment with sponsor requirements, internal policies, and applicable laws and regulations
Serving as a key point of contact for sites on contractual matters, addressing questions and resolving issues in a timely manner
Collaborating with legal, finance, and project teams to ensure consistency of contractual language and budget assumptions
Monitoring contract cycle times and providing input into strategies to reduce timelines and improve efficiency
Supporting the development and refinement of contract templates, playbooks, and negotiation guidelines

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Select Country

Site Contracts Lead

Job Description

Job Responsibility

Requirements

What we offer

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