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    Site Budget & Contract Specialist

    Innovaderm Research
    3+ years
    Not Disclosed
    Canada
    10 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: Montreal, Canada (with possibility of working from home as per company policies)

    Overview

    Innovaderm is seeking a Site Budget and Contract Specialist to be a key member of the Site Selection and Contracting team. This person will work closely with project teams and the legal/contract department to prepare, negotiate, and execute budgets and contracts (Clinical Trial Agreement – CTA) with investigator sites across Canada and internationally.

    Responsibilities

    Contracts and Budgets Preparation

    • Obtain the minimum and maximum site budget 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, including study information, timelines, and payment information, 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 to ensure the budget remains within Sponsor-approved limits and escalate issues as necessary.
    • Manage contract negotiations with sites, escalating legal language requests to Legal Affairs and Contracts, and the Sponsor as necessary.
    • Track progress with contract/budget negotiations and site activation timelines using CTMS or other tracking systems.
    • Keep the project team informed of progress and any potential delays.
    • Finalize the site contract/budget and obtain necessary signatures.
    • Inform relevant parties of contract execution in a timely manner.
    • Update CTMS, trackers, and ensure proper filing of contracts/budgets and communications.

    Follow Up and Close Out

    • Manage the site contract/budget amendments process during the trial.
    • Perform site budget reconciliation during negotiation and at study closure.
    • Coordinate with Legal Affairs and Contracts for the review and negotiation of confidentiality disclosure agreements with interested sites.
    • Maintain and develop productive, professional relationships with research sites, Sponsors, and project teams.
    • Participate in meetings with Project Managers and/or 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, including 2 years managing site budget negotiations.
    • Good knowledge of Good Clinical Practice (GCP), ICH standards, and applicable regulations.

    Knowledge and Skills

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

    About Innovaderm

    Innovaderm is a Contract Research Organization (CRO) specialized in dermatology, established in 2000. The company has built a solid reputation for the quality of its research and services and continues to grow across North America and Europe.

    Perks

    • Flexible work schedule.
    • Permanent full-time position.
    • Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities).
    • Offices located near public transportation (Sherbrooke metro station or Saint-Laurent metro station).
    • Possibility of working from home in accordance with company policies and public health directives.
    • Ongoing learning and development opportunities.

    Equal Opportunity

    Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. Accommodations are available during the recruitment and selection process for applicants with disabilities, upon request.

    Legal Eligibility

    Only applicants who can legally work in Canada will be considered.

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