Country Study Manager (Multiple Positions)

Job description

  Job facts

Title: Country Study Manager
Division: Product Develoment Global - Country Clinical Operations
Location: Mississauga - Head Office

Potential for Multiple Positions

Objective:

Provides leadership to one or more Local (Country/Region) Study Team and provides local strategic planning and organization to achieve successful study completion.

Maintains full ownership of the country/countries portion of a study and ensures the effective and efficient delivery of country/regional operational aspects in accordance with the study development plan and ICH/GCP standards, Roche SOPs, local operating guidelines and local regulatory requirements. Ensures the development and maintenance of productive relationships with our customers.

Responsibilities:

1. Leading the local/regional Study Team

·  Establishing and meeting country-level commitment regarding study timelines, patient recruitment, budget
·  Ensure adequate tracking of the relevant information into the dedicated company tools/systems
·  Taking ownership for management of all aspects of the study, in close collaborations with the Medical Manager.

2. Budgeting of the Assigned studies

·  Forecasting and tracking of the budget

3. To manage all operational aspects of studies from feasibility to study close down

·  Conducting Protocol and Site Feasibility
·  Performing / Supporting IRB/IEC submission and contract negotiation
·  Develop risk assessment and quality plans
·  Ensuring all assigned studies are undertaken in accordance to ICH/GCP standards, Roche SOPs and quality standards, local operating guidelines and local regulatory requirements
·  Development of relationships with Investigators and OLs

4. Training & Compliance Leadership

·  Accountable to ensure that the study team is duly trained and qualified
·  Collaborating in the preparation of audits and inspections and ensuring adequate CAPA follow up

·  Who we are

Roche Pharma - Canada has its office in Mississauga, Ontario and employs over 700 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.

Desired profile

Who you are

You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

Qualifications:

The ideal candidate with the following skills and qualifications:

·  Minimum of 4 year University degree or equivalent in a medical/science-related field
·  Minimum of 3 years of experience with: Project Management, Influencing and negotiating to achieve team delivery, Cost and financial awareness and Decision Making
·  Complete knowledge of ICH /GCP, Roche SOPs/ Guidelines and Quality standards related to study management.
·  Detailed knowledge of all operational aspects of Clinical Trial management.
·  The successful incumbent must be legally permitted to travel to the United States for business purposes

Qualified candidates are encouraged to apply before January 19, 2017.

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.

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

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