Pharm-Olam International

  • Site Activation Officer

    Job Locations PL-Warsaw
    ID
    2018-1861
    Category
    Regulatory
  • Overview

    About Pharm-Olam International:

     

    Pharm-Olam International is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package.

     

    Summary:

     

    As a Site Activation Officer together with Clinical Operations Manager you will be responsible for assisting in all related site activation activities at a regional level in Poland and Baltic countries.

    The Site Activation Officer can use different tools in CTMS during the Site Activation Lifecycle and will be responsible  to keep the Site Activation Milestones on track during the course of the study(s) therereby ensuring that expectations are met while identifying and mitigating the start up risks.

    Responsibilities

    Regulatory Authority (RA) submission/approval activities:

    • Advise the Global Regulatory Manager in the preparation, compilation, submission and maintenance of regulatory documentation required by regulatory agencies a for clinical trials and marketing applications
    • Prepare, compile and submit regulatory documentation
    • Prepare, compile answers for questions raised by the Regulatory Agency and submit the answers

    Independent Ethics Committee (IEC)/ Independent Review Board (IRB) submission/approval activities:

    • Advise the Global Regulatory Manager in the preparation, compilation, submission and maintenance of ethical requirements documentation required by Independent Ethics Committee (IEC)/ Independent Review Board (IRB) for clinical trials and marketing applications
    • Prepare, compile and submit regulatory documentation
    • Prepare, compile answers for questions raised by the Ethics Committee (IEC)/ Independent Review Board (IRB) and submit the answers

    Clinical Trial Agreement and Budget negotiation activities with sites:

    • To review and negotiate Clinical Trial agreements and budgets with sites
    • Stay connected with Investigator sites, Internal personnel, Global Site Contract Manager and Global Site Activation Manager regarding the status of contracts and contract related documents
    • Prepare and oversee preparation and contractual documents and correspondence
    • Facilitate the indemnification process between the study sponsor and the site
    • Responsible to arrange legal translation of the Final country CTA template
    • Responsible for internal review of the Country specific Site budget from GrantManager
    • Reponsible to include Site-level details in each final country CTA template and site budget
    • Responsible for sending the Site-specific CTA and site budget to site and start negotiation; ensure site changes are translated
    • Responsible for obtaining the final/draft CTA and site budget for submission where required
    • Responsible to obtain Site signature as well as Sponsor/Pharm-Olam signature if applicable

    Essential Document collection activities: Submisission of Essential Documents for an Investigator site and to authorize the shipment of Investigational Product to the site:

    • Responsible for preparation of Site Specific Essential Document Package (at site level) and sending to sites
    • Responsible for collection and first review of Essential Documents
    • Responsible to provide the Global Essential Document Reviewer with the collected documents for independent review
    • Responsible to follow up with the sites all the discrepancies noted by the Global Essential Document Reviewer until resolution to authorize the shipment of Investigational Product to the site

    Working Relationships: 

    • Report directly to Clinical Operations Manager
    • Collaborate with the Global Regulatory Manager/Global Site Activation Manager
    • Collaborate with  Clinical Research Associates if needed
    • Collaborate with Clinical Trial Administrators, Global Site Budget Analyst, Support Services and Quality Assurance personnel
    • Collaborate with local office management and Information Technology
    • Liaise with national regulatory agencies and competent authorities
    • Liaise with Ethics Committee (IEC)/ Independent Review Board (IRB) websites/plataforms and/or contact Ethics Committee (IEC)/
    • Liaise with sub-contractors

    Qualifications

    • Four Year college curriculum, Legal Degree or BS/BA degree or higher university degree in life sciences, nursing or medical or biological science background or equivalent will be prefered; 
    • Generally 3-5 years experience in regulatory affairs in the pharmaceutical or biotechnology industry; preferably working with IEC/IRB
    • Generally 3-5 years experience maintaining project documentation specific to essential documents, collection and review per ICH/GCP requirements prior to Investigational Product release to the sites in the pharmaceutical or biotechnology industry
    • Generally 3-5 years experience with CTA and budget negotiations in the pharmaceutical or biotechnology industry
    • A basic knowledge of European and CEE regulatory submission and reporting requirements and guidelines.
    • A basic knowledge of European and CEE Ethics Committee (IEC)/ Independent Review Board (IRB) and reporting requirements and guidelines.
    • Basic understanding of the drug development process.
    • Ability to pay close attention to detail.
    • Strong organizational, planning, strategizing, managing, monitoring, scheduling, numerical and critiquing skills
    • Excellent written and verbal communication skills to clearly and concisely present information
    • Excellent interpersonal skills and strong team player; ability to coordinate and collaborate above, across and within complex projects in a fast-paced, deadline oriented, and changing environment
    • Excellent negotiation skills with ability to challenge without alienating internal and external stakeholders
    • Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment
    • Ability to exercise independent judgment taking calculated risks when making decisions
    • Ability to establish and maintain effective relationships with co-workers, managers and sponsors
    • Strong computer skills with an ability to understand access and leverage technology alternatives
    • Proficient in use of Microsoft Word, Excel and PowerPoint
    • Experience in CRO, pharmaceutical or other relevant area
    • Occasional travel.

    For Consideration

     

    Pharm-Olam International, LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

    This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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