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    Site Budget & Contract Specialist (Poland)

    Innovaderm Research
    3+ years
    Not Disclosed
    Poland
    11 Nov. 24, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Position: Site Budget and Contract Specialist
    Company: Innovaderm
    Location: Remote (Poland)

    Overview

    Innovaderm is seeking a Site Budget and Contract Specialist to join the Site Selection and Contracting team. This role involves close collaboration with project teams, legal/contract departments, and external partners to prepare, negotiate, and execute budgets and contracts (Clinical Trial Agreements – CTAs) with investigator sites across Canada and internationally.

    Responsibilities

    Contracts and Budgets Preparation

    • Obtain the minimum and maximum site budgets, as prepared by Business Development and approved by the Sponsor.
    • Retrieve the project-specific site CTA template from Legal Affairs and Contracts, approved by the Sponsor.
    • Prepare the contract schedule (study information, timelines, and payment details) in collaboration with the Project Manager.
    • Prepare and send the Sponsor-approved contract and budget to sites for review.

    Contracts and Budgets Negotiations

    • Manage budget negotiations with sites, ensuring that budgets stay within the Sponsor-approved limits; escalate issues as needed.
    • Handle contract negotiations with sites and escalate legal language requests to Legal Affairs and Contracts or the Sponsor.
    • Track progress on contract and budget negotiations, and monitor timelines for site activation using CTMS or other tracking systems.
    • Keep the project team informed of progress and potential delays.
    • Finalize site contracts and budgets, ensuring all necessary signatures are obtained.
    • Inform the appropriate parties of contract execution promptly.
    • Update CTMS and trackers, and ensure proper filing of contracts, budgets, and communications.

    Follow-up and Close-out

    • Manage the site contract/budget amendment process throughout the trial.
    • Perform site budget reconciliation during negotiation and at study closure.
    • Coordinate with Legal Affairs and Contracts for reviewing and negotiating the confidentiality disclosure agreement (CDA) for interested sites.
    • Maintain a productive and professional relationship with research sites, Sponsors, and project teams.
    • Participate in meetings with Project Managers and Sponsors, as required.

    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, with at least 2 years managing site budget negotiations.
    • Good understanding of good clinical practice, ICH standards, and applicable regulations.

    Skills

    • Excellent written and spoken English.
    • Ability to manage multiple projects simultaneously, organize work effectively, and meet deadlines under pressure.
    • Strong judgment and problem-solving skills.
    • Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
    • Customer service experience is an asset.
    • Strong interpersonal and communication skills.

    Work Environment

    At Innovaderm, you will work with brilliant colleagues in a dynamic and collaborative environment. We prioritize innovation, reliability, and responsiveness, and offer ample opportunities for professional growth.

    Perks

    • Permanent full-time position.
    • Flexible work schedule.
    • Vacation benefits.
    • Home-based position.
    • Ongoing learning and development opportunities.

    Work Location

    This position is remote, based in Poland. Flexibility in working hours is required to accommodate team or client meetings across various time zones.

    About Innovaderm

    Innovaderm is a contract research organization (CRO) specializing in dermatology. Since 2000, Innovaderm has earned a solid reputation for delivering high-quality research and services that exceed client expectations. Based in Montreal, we continue to grow and expand across North America and Europe.

    Equal Opportunity

    Innovaderm is committed to providing equitable treatment and equal opportunities. We offer accommodations during the recruitment process for applicants with disabilities, upon request.

    Legal Eligibility

    Innovaderm only accepts applicants who can legally work in Poland.

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