Covance

  • Clinical Operations Specialist

    Job Location(s) IN-Bangalore | IN-Bangalore
    Job Number
    2018-17117
    Job Category
    Clinical Operations
    Position Type
    Full-Time
  • Job Overview

    Work Location: Bangalore

     

    The Clinical & Ancillary Supplies Services (CASS) Specialist I:

    • Support the delivery of the Clinical and Ancillary supplies component of assigned studies within a country or 1 region.
    • Act as contact with study team during clinical and ancillary start-up activities including input to the development of Clinical Trial Supplies Plan or Clinical Trial Supply Flow for a given group of countries in a region.
    • Perform and coordinate label review and country translations according to set procedures for a global study.
    • Responsible for working with project team to ensure the required documents and processes related to supply management are communicated and obtained.
    • Where appropriate be the key contact for importation logistics and document exchange to ensure smooth clinical supply transportation arrangements are agreed and set up.
    • Provide consultancy with regard to clinical & ancillary supply distribution strategy for the assigned country(ies) in a region.
    • Responsible for maintenance of project specific clinical & ancillary supply logistics.
    • Work closely with drug and ancillary supply distribution, IVRS/IRT and label translation vendors during the set up and maintenance of related logistics

     

    Essential Job Duties:                                                                

    • Understand and follow project specific and Covance policies and procedures
    • Support the development of project specific plans for the Clinical and Ancillary supply component of assigned studies
    • Represent Clinical and Ancillary supplies component for country(ies) in the region at client and internal project meetings
    • Liaise with operational project team regarding project issues (i.e., participate in team meetings)
    • Liaise with Sponsor and Covance regulatory regarding clinical supply related submission requirements
    • Attend ongoing training, project specific requirements and as may generally be required
    • Provide milestone information for the country(ies) in the region
    • Review the protocol to confirm if Covance/ other vendor can import all the supplies required.
    • As necessary, provide support to GRS to request import licenses and manage these import licenses as needed for the protocol  
    • Coordinate and track shipments to sites required for each protocol as appropriate in the region
    • As appropriate, manage and communicate with the couriers and brokers in each of the participating countries in the designated region
    • As appropriate, support payment process to the couriers and brokers in each of the participating countries in the designated region
    • As appropriate review commercial invoices and airway bills according to each individual shipment and country
    • Update the Importation Process for each respective country in the region as needed
    • Liaise with all the operational groups (Project Management, Clin Ops, GSS, GRS) at Covance in order to provide status reports for import process
    • Work with GRS on obtaining, understanding and interpreting country-specific requirements and regulations for the importation of CT supplies.
    • Perform administrative tasks required during study start up activities (e.g., word processing, assembly of study documents, mass mailings, filing, faxing/photocopying)
    • Manage the country / regional drug supply vendor activities as applicable
    • Oversee importation logistics and document exchange to ensure smooth clinical supply transportation arrangements are agreed and set up.
    • Develop, review and approve drug supply labels as applicable
    • Coordinate ancillary supply logistics with various vendors or internal team
    • Independently research and evaluate proposal request from clients in all therapeutic areas within agreed timeframes
    • Assist with preparation of materials for formal client/industry presentations and for internal training assignments
    • Conduct QC of documents as required by the process
    • Undertake literature and internet searches as required
    • Mentor other team members
    • Perform other duties as assigned by management

     

    Top 3 reasons you should join us:

     

    1. Energizing purpose: Our work improves lives. Covance has helped pharmaceutical and biotech companies develop 100% of the top 50 prescription drugs in the marketplace today. You will personally contribute every day to advancing healthcare.
    2. Exceptional people: You will join a growing team of people who have a common goal for exceptional service and quality. You will learn from the most talented minds and subject matter experts, in an agile, supportive, and caring environment.
    3. Extraordinary potential: You will work in a most stimulating and a flexible work environment that will help you thrive personally and professionally.

     

    Get to know Covance

    Covance, a $15 billion Fortune 500 company, with operations in over 97 countries, has led the way in improving patient outcomes through visionary data sciences over the last five decades. We have supported 100% of the top 50 drugs in the market and all the oncology medicines approved in 2016. Our team of over 57,000 across the globe is committed to advancing healthcare and bringing new medicines to market sooner. Our unique perspectives, built from decades of scientific expertise and precision delivery, help our clients identify new approaches and anticipate tomorrow’s challenges as they evolve. Driven by a passion for excellence and a relentless commitment to quality, we unlock opportunities that advance innovation and deliver the promise of a healthier world.  Together, with our large pharmaceutical and emerging biotech clients, Covance transforms today's health care challenges into tomorrow's solutions.

     

    Over the years we have been recognised and applauded for our efforts in the creation of personalised medicines and innovative therapies to deliver on the promise of a healthier world. Some of our recent accolades:

    • LabCorp named in FORTUNE Magazine's 2018 list of ‘World’s Most Admired Companies”
    • Frost & Sullivan Best Practice Award – Asia Pacific CRO Growth Excellence Leadership Award
    • IMDiversity – Corporate Diversity Honor Roll
    • Flexjobs – Top 100 Remote Work – Company to Watch
    • Life Science Strategy Group – Rated as the CRO “Making the right moves to be successful in the future”

    To learn more about our exciting opportunities in India, visit www.Covance.com/IndiaCareers

    Education/Qualifications

    Education:

     

    Graduate or Bachelor’s degree in Life Sciences (or Pharma or related health discipline) from an accredited university or college.

    Experience

    Required:

    • Minimum of 2 years relevant clinical research experience in a pharmaceutical company/CRO, including at least 1 year of clinical and ancillary supplies management responsibility.
    • Working knowledge of ICH, FDA, GMP and other applicable regulations/guidelines; familiarity with clinical supply related documents
    • Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe
    • Good organizational and time management skills
    • Excellent communication / writing skills
    • Strong computer skills with an ability to access and leverage technology alternatives
    • Abilities to review/analyze relevant data so as to assist in building evidence-based clinical trial strategies
    • Self-motivation with the ability to work under pressure to meet deadlines
    • Works well independently as well as in a team environment
    • Detail and process oriented
    • Positive attitude and approach
    • Multi-tasking capability
    • Ability to work independently

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