Key Facts

Remote From:

Full time

Mid-level (2-5 years)

English

Hard Skills

Clinical Trial Management Systems Contract Management Digital File Management Budget Management Contract Management Contract Management Intellectual Property Project Coordination Tracking Systems (Geolocation) Project Management +1 more

Other Skills

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Microsoft Office
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Customer Service
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Collaboration
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Communication
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Time Management
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Relationship Management
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Problem Solving

Roles & Responsibilities

Bachelor's degree in a field relevant to clinical research or equivalent experience
Minimum of 3 years of clinical research experience in the biotechnology, pharmaceutical or CRO industry, including 2 years of experience managing site budget negotiation
Good knowledge of Good Clinical Practice, ICH standards and applicable regulations
Excellent English written and spoken skills; strong interpersonal skills and proficiency in Microsoft Office Suite

Requirements:

Prepare contracts and budgets: obtain minimum and maximum site budgets prepared by Business Development and approved by the Sponsor; obtain the project-specific site CTA template from Legal Affairs and Contracts approved by the Sponsor; prepare the contract schedule in collaboration with the Project Manager; prepare and send Sponsor-approved contract and budget to sites for review
Negotiate contracts and budgets: manage budget negotiation within Sponsor-approved limits and escalate issues as necessary; manage contract negotiation with sites and escalate legal language requests to Legal Affairs and Contracts and to the Sponsor; keep track of progress with contract/budget negotiation and timelines using CTMS or other tracking system; finalize the site contract/budget and obtain necessary signatures
Follow-up, updates and close-out: inform appropriate parties of contract execution in a timely manner; update CTMS, all necessary trackers, and ensure proper filing of the contract/budget and communications; manage site contract/budget amendments process during the course of the trial; perform site budget reconciliation during the negotiation process and at study closure; coordinate review and negotiation of confidentiality disclosure agreements with Legal Affairs as needed
Relationship management and coordination: maintain and develop productive and professional relationships with research sites, Sponsor and project teams; participate in meetings with Project Managers and/or Sponsor as required

Innovaderm Research Inc.

Pharmaceuticals

About Innovaderm Research Inc.

As a CRO (Clinical Research Organization) specialized in dermatology, we provide scientific guidance, accurate results and customer satisfaction. Our unique service offering combines specialized Contract Research Services, knowledge of dermatology sites in North America and Europe reach and the extended capabilities of a large clinical research site. The design and conduct of Phase 1 to Phase IV studies in Dermatology is our core expertise. Our specialized services include: • Study Design and Protocol Development • Submission to Regulatory Agencies and Central Ethics Committees • Regulatory Consulting • Trial Master Files Management • Project Management • Investigator / Site Selection • Patient Recruitment • Clinical Monitoring • Medical Monitoring • Pharmacovigilance • Data Management • Biostatistical Analysis • Clinical Study Report • Medical Writing / Publication Since 2000, Innovaderm has built a strong reputation for the quality of its research and the care offered to its study participants, its clients and its sites, often exceeding our client’s timeline expectations.

Company type: SME

Industry: Pharmaceuticals

Founded: 2018

Company size: 201 - 500

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Job description

Description

The Site Budget and Contract Specialist is a key member of the Site Selection and Contracting team. This person works closely with project teams as well as the legal / contract department in the preparation, negotiation and execution of budgets and contracts (clinical trial agreement – CTA) with investigator sites across EU, North America and other countries.

This role will be perfect for you if:

You can easily achieve consensus while maintaining positive working relationships with external partners
Your team can count on you to get things done
You have an ease to work with numbers (standardized budgets)

RESPONSIBILITIES

Contracts and budgets preparation

Obtains the minimum and maximum site budget prepared by Business Development and approved by the Sponsor.
Obtains the project-specific site CTA template from Legal Affairs and Contracts approved by the Sponsor.
Prepares the contract schedule (study information, timelines and payment information) in collaboration with the Project Manager.
Prepares and sends the Sponsor-approved contract and budget to sites for review.

Contracts and budgets negotiations

Manages budget negotiation with the sites to ensure budget remains within the Sponsor-approved limits and escalate issues as necessary
Manages contract negotiation with sites and escalates legal language requests to Legal Affairs and Contracts and to the Sponsor, as necessary
Keeps track of progress with contract/budget negotiation and timelines for site activation using CTMS or other tracking system
Keeps project team informed of progress and of any potential delays
Finalizes the site contract/budget and obtains the necessary signatures
Informs the appropriate parties of contract execution in a timely manner
Updates CTMS, all necessary trackers, and ensures proper filing of the contract/budget and communications

Follow up and close out

Manages the site contract / budget amendments process during the course of the trial
Performs site budget reconciliation during the negotiation process and at study closure
May coordinate, with Legal Affairs and Contracts, the review and negotiation of the confidentiality disclosure agreement of the interested sites
Maintains and develops a productive and professional relationship with research sites, Sponsor and project teams
Participates in meetings with Project Managers and / or Sponsor as required

Requirements

IDEAL PROFILE

Education 

Bachelor's degree in a field relevant to clinical research or equivalent experience.

Experience 

Minimum of 3 years of clinical research experience in the biotechnology, pharmaceutical or CRO industry, including 2 years of experience managing site budget negotiation
Good knowledge of good clinical practice, ICH standards and applicable regulations

Knowledge and skills

Excellent English written and spoken skills.
Strong ability to carry out different projects simultaneously, to organize their work effectively, and to work under pressure in accordance with deadlines.
Good judgment and problem-solving skills.
Excellent knowledge of the Microsoft Office suite (i.e., Word, Excel, PowerPoint, Outlook).
Experience in customer service is an asset
Strong interpersonal skills.

Our company

The work environment

At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

In this position, you will be eligible for the following perks:

Flexible work schedule
Permanent full-time position
Company benefits package
Ongoing learning and development

About Indero

Indero is a CRO specialized in dermatology and rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in Spain.