Covance

  • Start-up Assoc Project Manager

    Job Location(s) PL-Warsaw
    Job Number
    2018-24596
    Job Category
    Clinical Monitoring
    Position Type
    Full-Time
  • Job Overview

    Are you someone with previous regulatory submissions experience looking for developing your career within this area?

    At Covance we are recruiting for a SSU Associate Project Manager to work sponsor dedicated into a top 5 pharmaceutical company.

     

    Responsibilities:

     

    • Assignment of site numbers
    • Identification of patients documents required for translation
    • Assessment of local sourcing availability of drug
    • Start-up timelines estimation
    • Oversight and coordination of CTC tasks during validation (support)
    • Coordination of collection of site documents required for EC/HA submission
    • Local ICF adaptation
    • Review and adaptation of patient recruitment and retention materials
    • Recruitment materials –
    • Cooperation and support of contract/financial team during contracting process
    • Providing update to study team members, i.e. CRM, CRAs, RCPM, CTC regarding current start-up status
    • Local IMP, drug and non-clinical supplies management
    • Coordination of preparation of ITFB

    Education / Qualifications

    • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
    • In lieu of the above requirement, candidates with minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting will be considered
    • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
    • Thorough understanding of the drug development process
    • Fluent in local office language and in English, both written and verbal

    Experience

    • Good organizational and time management skills
    • Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred.
    • Excellent communication skills, oral and written.
    • Self-motivation with the ability to work under pressure to meet deadlines
    • Works well independently as well as in team environment.
    • Detail and process oriented
    • Positive attitude and approach
    • Interact with internal and external customers with high degree of professionalism and discretion
    • Multi-tasking capability.
    • Good computer skills with good working knowledge of a range of computer packages
    • Ability to lead and develop junior staff
    • Flexible and adaptable to a developing work environment

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