Covance

  • Start-up Country Mgr

    Job Location(s) DE-Munich
    Job Number
    2018-26693
    Job Category
    Clinical Study Start Up
    Position Type
    Full-Time
  • Job Overview

    The Manager, Start-up Operations is accountable for delivering on-time, high quality study start-up and maintenance activities within a country, or country cluster, as well as for central/local IEC/IRB submission, document collection, update of relevant systems and filing. This role will lead a start-up team within a country or a cluster of countries that will work to activate study sites and ensure the filing of documentation into the eTMF system and completion of CTMS from the start to the end of the start-up period, including maintenance throughout the cycle of the study. The Manager, Start-up Operations will also have direct line management responsibility for the start-up operations team in their country or a cluster of countries and oversight of all country-level client deliverables and timelines of start-up at the country and site levels. The Manager, Start-up Operations will act as a local point of contact for activities around start-up deliverables in the country. The Manager, Start-up Operations will have operational detailed oversight, ensuring right commitments and right timelines are met. The Manager, Start-up Operations will be the first line of escalation for performance issues and quality concerns and will have the necessary overview to confirm country start-up stays on track. This role will serve as the local Subject Matter Experts (SME) for start-up processes including timelines, training and development of the start-up team at the local level and on local regulations

     

    • Has accountability for quality, performance and GCP compliance for start-up operations staff
    • Has accountability for delivery of all country level start-up deliverables and timelines
    • Has accountability for legal and regulatory requirement compliance for study activation and may include maintenance
    • Has line management responsibility for all start-up staff in country or in cluster of countries
    • Has recruitment, allocations, coaching, trainings and talent development responsibility for Start up operational (SU Ops) staff
    • Is responsible for resource and utilization management of start-up operations staff
    • May act as local contact for business development/client relations, works closely with strategic clients and ensures client satisfaction
    • Can be involved in local vendor management (sub-CRO and suppliers)

    Education / Qualifications

    Recommended:

    Level of education preferred (if required or experience level which may be substituted for level of education).

    Professional degree/designations/certifications/licenses legally required (i.e. RN, MD, VDM etc.).  

    Required:

    • University/college degree – life sciences preferred or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
    • In lieu of this required educational background the following relevant work history may be considered:
      • Minimum of three (3) years supervisory experience in a health care or clinical research setting and
      • Minimum of seven (7) years relevant clinical research experience in a pharmaceutical company/CRO

    Preferred:

    • Masters or other advanced degree

    Experience

    Minimum Required:

    * More than 5 years of experience in clinical development or regulatory process.

    * In depth experience of applying strong knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines. Expert knowledge of investigator start-up documents; previous interaction with operational project teams and investigative sites.

    * In depth experience of issue escalation and resolution.

    * Credible role model in effective communication and problem solving.

    * Proven strengths managing relationships and negotiating solutions while maintaining a level of approachability with colleagues both internal and external to the organization.

     

    Relevant supervisory experience

    • Demonstrated ability to lead by example and to encourage team members to seek solutions
    • Proven interpersonal skills
    • Demonstrated ability to successfully participate as a member of a project team
    • Demonstrated ability to successfully manage multiple competing priorities
    • Advanced planning and organizational skills
    • Advanced verbal, written and presentation skills

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