Country Study Specialist- 1 Year Contract
F. Hoffmann-La Roche Ltd
8d ago

Title : Country Study Specialist -1 Year Contract

Department : Country Clinical Operations

Location : Mississauga Campus

Objectives :

The Country Study Specialist (CSS) is responsible for providing project co-ordination and operational solutions to support Country Study Managers (CSMs) and to provide clinical trial oversight to local study teams to enable effective trial management.

Responsibilities :

  • Provide essential operational co-ordination and support to Country Study Managers (CSMs) and Local Study Teams (LSTs)
  • Proactive contribution to study start-up and patient recruitment strategies and activities to support efficient trial management
  • Study communication via development and distribution of affiliate newsletters for investigators and LSTs
  • Support CSM by ensuring that Monitors have site recruitment plans, site activations are happening according to timelines and non-
  • productive sites are closed

  • Responsible for the co-ordination and oversight of local affiliate study level audit / inspection audit action plan activities
  • Coordinate country communication plan, budget and payment plan based on country financial plan
  • Ensure collection of site level documents to support country ethics approval and health authority processes
  • Provide required local customs documentation to meet country requirements for importation / exportation
  • Provide proactive project co-ordination and study oversight actively involving respective internal and external LST members
  • Ensure that monitoring reports are being submitted by Clinical Research Organization (CRO) and escalate to CSM as needed;
  • Review monitoring reports in conjunction with CSM as required

    Qualifications :

  • 4 years University Degree or Equivalent in a life sciences or nursing preferred.
  • 3 years’ work experience demonstrating knowledge and understanding of clinical trials
  • Previous experience managing projects is desirable.
  • Experience working as part of a team with a proven ability to make an active contribution to the team's performance and teamwork
  • Able to prioritize and manage multiple tasks with high flexibility
  • Proven project management skills to work with a variety of different systems and stakeholders and deliver commitments on time and with quality
  • Self-motivated and displays initiative / resourcefulness
  • Ability to work independently with limited supervision
  • Strong attention to detail
  • Demonstrated computer literacy, usage of MS Office software, web-based systems and databases.
  • Ability to communicate clearly and accurately in both written and spoken English
  • The successful incumbent must be legally permitted to travel to the United States for business purposes
  • Qualified applicants are encouraged to submit cover letter and resume no later than September 28, 2018.

    This position is not eligible for relocation support.

    This position is open to applicants legally authorized to work in Canada.

    NOTE : All employment is conditional upon the completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks.

    Roche is an equal opportunity employer and prohibits unlawful discrimination based upon any legally protected ground. Roche will make a good faith effort to accommodate the individual needs of applicants with disabilities in our recruitment process

    AGENCY NOTICE : Please note that Roche Canada does not accept unsolicited resumes from recruiters or employment agencies.

    In the absence of a signed Services Agreement with agency / recruiter, Roche Canada will not consider or agree to payment of any referral compensation or recruiter fee.

    In the event a recruiter or agency submits a resume or candidate without a previously signed agreement, Roche Canada explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

    Roche is an equal opportunity employer.

    Research & Development, Research & Development >

    Clinical Development

  • Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche's truly innovative culture.
  • Roche is an equal opportunity employer.

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