Clinical Operations Lead ____ Mississauga, ON, Canada (Hybrid) ___ Contract

Provides operational expertise and leadership to one or more cross-functional global Study Management Teams (SMTs)
Ensures the timely and efficient delivery of all operational aspects of one or more studies through all phases (phase 1b-IV) and stages (start-up conduct and close-down) in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.


Main Responsibilities and Accountabilities:
Drives study timelines budget risk and operational study plans while ensuring quality and compliance
Oversight of country operations activities (managed by country COLs on the study and the CRO on outsourced studies)
Set up maintain oversight of and close any vendors that the study requires to run smoothly. Track study budget and approve invoices.
Provides the day-to-day operational management of CROs and vendors (e.g. Central Labs IxRS etc.) to ensure delivery against contracted scope of work
Responsible for leading identification and selection of vendors; ensuring appropriate cross-functional input is incorporated into the scope of work
Responsible for assessing feasibility of and driving execution/adherence to protocol amendments or changes to clinical studies across functions
Establishes study milestones and ensures accurate tracking and reporting of study metrics such as initial recruitment projections
Leads the creation of the study level patient recruitment plan and retention strategies Provides operational input and insight into all study related documentation (including protocol and informed consent form) and processes
Analyzes the feasibility data across countries with input from the affiliates and makes recommendations to the Study Lead for the strategic country and site distribution and patient numbers
Designs drug assumption and supply chain process in partnership with Drug Supplies affiliates and GSL
Oversees the forecasting and management of non-clinical supplies to ensure sites have supplies to run clinical study
Chairs operations team meeting and organizes investigator meetings monitor training CRO kick-off meetings
Actively partner with Data Management and Clinical Science to oversee eCRF completion and data quality issues
Ensures the completion and finalization of any corrective and preventative action plans resulting from site audits in conjunction with CCO etc. as necessary

Coordinates responses to study questions or issues from Health Authorities

Provides operational input into the development and tracking of SMT goal

Creates team culture and promotes team spirit
Ensures study adherence to ICH/GCP and SOPs


What is expected of everyone in PDG:

Portfolio Delivery: Take responsibility and accountability for portfolio delivery actively partnering and influencing stakeholders fostering collaborative relationships and contributing to overall success and patient care advancement.
Compliance: Know and adhere to respective compliance requirements including training and execute all work in a compliant manner. Updates knowledge on related regulatory requirements ensures adherence and compliance with local regulations and internal procedures.
Administrative Tasks: Perform administrative tasks in a timely fashion while following guidelines laid out in policy manuals (e.g. expense reporting travel guidelines time reporting).
Office Presence: Maintain office presence in line with local guidelines.

Financial Stewardship: Demonstrate responsible stewardship of spend and resources.

Data Quality: Ensure accurate and timely input and updates of respective data contributing to overall data integrity and quality.
Execution of Plans: Ensure plans are executed to impact or progress PDG Strategy and Outcomes.
Adhere to Roche Operating Principles and R&D Excellence Performance Expectations


Qualifications and Experience
University Degree or equivalent preferably in a medical/science-related field.

Strong understanding of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practices (ICH-GCP).

Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in a Global environment and/or including monitoring or leading affiliate teams working with vendors and/or CROs drug supply management and planning operational activities to achieve database lock.
Experience of project managing operational aspects of a clinical study including development and management of timelines and budgets.
Good knowledge of ICH GCP
Proven ability to successfully achieve results within a multi-cultural and geographically diverse team.
Experience of working as part of a large team and leading small study or functional teams with a proven ability to be an active member of the team and motivate and lead a small team to deliver against commitments.
Well-developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization.
Strong attention to detail
Proficient computer skills



Competencies:
Planning & Organizing: Proactively establishes efficient action plans sets priorities timelines and leverages resources to achieve goals.
Customer Focus & Loyalty: Exceeds internal and external customer expectations building strong trusting relationships.
Communication: Conveys information clearly concisely and engagingly; actively listens.
Building Partnerships: Develops strong strategic relationships with key external accounts and internal stakeholders to achieve business objectives.
Initiating Action: Takes prompt proactive steps to accomplish work goals and achieve results beyond what is required.
Work Standards: Sets and maintains high performance standards assuming responsibility and accountability for successful task completion.
Earning Trust: Acts with integrity follows through on commitments and treats others and their ideas with respect.
Decision Making: Effectively identifies and analyzes problems using quantitative and qualitative information making timely and optimal decisions consistent with facts and constraints.
Adaptability: Maintains effectiveness and adjusts positively to significant changes in work responsibilities environment and culture.
Influencing: Uses effective strategies to gain acceptance of ideas and commitment to actions that support work outcomes.
Innovation: Creates novel measurable solutions for customers; experiments with new approaches to problem-solving and seizes unique opportunities.
Technical/Professional Knowledge: Possesses a satisfactory level of technical and professional skill in relevant areas stays current with developments and leverages expertise for results.

Note: This is a Hybrid role. The ideal candidate will work at the Mississauga Campus three (3) times every week

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