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COVANCE DENMARK - is recruiting for Global Site Services Specialist/ S - Oferta z Jobs.pl

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COVANCE DENMARK - is recruiting for Global Site Services Specialist/ S

Nr ref.: /JOBS.pl

  • COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.

    You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance's impressive history of company stability and growth. We've achieved these results by fostering a work environment that encourages, develops and leverages our team's capabilities. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.

    We are currently recruiting for Global Site Services Specialist/ Start Up Specialist in Denmark.

    About the job:

    - Develop project specific plans for the GSS component of assigned studies
    - Liaise with operational project team regarding project issues (i.e., participate in team meetings)
    - Collect, review, approve process and track regulatory & investigator documents required for study site activation in accordance with Covance SOPs, sponsor SOPs, GCP ICH guidelines and the Investigator Package Plan
    - Review and approve core English patient informed consents for compliance to international requirements and protocol as applicable
    - Review and approve core Country patient informed consents for compliance to country requirements and protocol as applicable
    - Review and approve investigative site specific patient informed consents for required elements
    - Resolve informed consent and contractual language issues by exercising advanced judgment when interacting with study sites
    - Negotiate contracts and budgets with investigative sites within parameters provided by Sponsor
    - Liaise with Sponsor and Covance regulatory regarding document submission requirements
    - Maintain and update document tracking, site address and contact information in the Site Information
    - Assess impact of changes in study personnel and document amendments on regulatory documents (including Informed Consent) and process/review/approve new documents according to GCP/ICH guidelines
    - Assess impact of study amendments on Informed Consent and other study documents and revise and review/approve accordingly
    - Prepare new investigator submission packages to Local and/ ot Central IRB /IEC
    - Attend ongoing training in GCP, project specific requirements and as may generally be required
    - Provide milestone information for incorporation into weekly analysis sheets
    - Monitor performance of GSS team with regard to project timelines
    - Perform administrative tasks required during study start up activities (e.g., word processing, assembly of study documents, mass mailings, filing, faxing/photocopying)
    - Manage set up and maintenance of investigative site files
    - Understand and follow project specific and GSS policies and procedures
    - Manage the drug supply vendor activities as applicable
    - Develop, review and approve drug supply labels as applicable
    - Independently research and evaluate proposal request from clients in all therapeutic areas within agreed timeframes
    - Assume responsibility for the preparation and dissemination of documents according to the feasibility processes in place
    - Create surveys to probe "thought leaders" and Experience d researchers and clinicians in the field for expert feedback
    - Assist with preparation of materials for formal client/industry presentations and for internal training assignments
    - Apply basic understanding of data spreadsheets and tables
    - Assist with entering data into spreadsheets when required
    - Review and audit data tables and spreadsheets for feasibility assessments
    - Conduct follow-up calls/telephone interviews with Investigators/Study Coordinators to solicit in-depth information related to feasibility and obtain further detailed information regarding potential proposals
    - Prepare internal feasibility reports by summarizing information obtained during previous feasibility assessments, historical Covance study Experience , and Investigator self-reported data
    - Establish, conduct and maintain relevant QC processes in regards Feasibility Assessments
    - Conduct QC of feasibility documents as required by the process
    - Undertake literature and internet searches as required
    - Act as point person for global feasibility studies as assigned: maintain open communication with global colleagues, provide feasibility study Investigator packet, collect data from appropriate regions and generate the formal report
    - Mentor other GSS team members
    - Effectively manage multiple feasibility projects of varying levels of complexity within agreed turnaround cycles.

    About You:

    - University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 2 years work Experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.
    - Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents; previous interaction with operational project teams and investigative sites
    - 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


    EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.

    Regional, DNK

    Regional, Denmark


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