• The Senior/Project Manager plans, directs, coordinates, and delivers activities for designated clinical-study projects to ensure that project objectives of quality, scope, cost, and time are accomplished. • PM will either manage regional trials (moderate complexity) and/or supportive role in managing complex global trials. • Serve as primary point-of-contact and primary escalation point to the client • Coordinate and oversees all functional services including external vendors to the established timeline and budget • Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate. • Ensure functional areas are fully aware of the study scope and are managing the scope for their functional areas accordingly. • Manage the financial health of assigned studies, including oversight of the project profitability, billable project hours, and compliance with on time, accurate billing and forecasting to support business objectives. • Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and quality • Ensure Quality management for assigned projects, including eTMF Inspection readiness, implementation of quality notification incident forms and / or corrective and preventative action plans to address any quality findings. • Maintain integrated collaboration with all functional operations in the delivery of the program and review as necessary of other study documentation • Establish tracking metrics to monitor trial and team progress towards project goals • Prepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise • Lead both internal and client meetings and set expectations for the project team • Communicate effectively with client and Precision management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues • Ensure study specific training is implemented in collaboration with functional areas and ensure study specific training compliance for the duration of the project • Support business development and marketing activities as appropriate, including travel to Bid Defence meetings as required • Perform other duties as assigned by management • Remain compliant with organisational training, time-reporting and any other administrative duties as required • Provides on-going feedback for functional team members including annual performance reviews • Ability to travel domestically and internationally including overnight stays

• Preparing and coordinating regulatory submissions to Health Canada, Research Ethics Boards (REBs), and Institutional Review Boards (IRBs). • Completing and maintaining Clinical Trial Site Information (CTSI) documentation. • Managing regulatory documents and study files to ensure compliance and inspection readiness. • Supporting multiple clinical studies simultaneously (typically 15+ active protocols). • Processing clinical trial invoices accurately and efficiently. • Tracking study documentation, regulatory milestones, and operational deliverables. • Working cross-functionally with clinical operations, regulatory, and study teams to ensure timely study execution. • Maintaining accurate records within study systems and databases. • Supporting study start-up, maintenance, and closeout activities while ensuring adherence to sponsor processes and regulatory requirements.

• Manages staff, providing coaching, mentorship and work direction • Conducts regular performance appraisals and career discussions with staff. Facilitates employee career development. Interviews, recruits and selects staff. • Manages and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company. • Ensures all staff CVs, training records, position profiles and experience profiles are complete and up-to-date. Ensures timeliness and accuracy of timesheets and expense reports. • Supports allocation activities per the local resourcing process. Supports activities of project leads/functional leads to optimize the operational running of projects. Raises appropriately any issues which may impact project deliverables. • Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact on clinical operations. Identifies training gaps and ensures that training requirements are met. May contribute to development of training programs, where appropriate. • Assures adherence to good ethical and regulatory standards. • Alerts management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required. • Handles and reviews systems (e.g. Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status. • Evaluates work of staff, including conducting PAVs (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable. • Participates in process improvement/development initiatives. • Ensures understanding and facilitation of the risk-based monitoring approach. • May provide input into bids and contribute to the procurement of new business where required. • Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required. • May lead or contribute to initiatives that enhance the department's performance or lead to process improvement across the company.

• Function as a member of the study-specific project team for simple systems, including understanding the systems, providing support related training of the systems and is responsible for the completion of all support related project deliverables. • Assist functional area leads and senior peers in identifying and evaluating fundamental issues on projects. • Gather information regarding potential or actual risks/issues and provide detailed information to management to ensure risks/issues are surfaced and mitigated. • For simple systems, perform study specific informal testing, create and review study specific system support guidelines for accuracy and completeness. • Prepare, coordinate and deliver meeting materials and communications per timeline milestones. Attend meetings and communications with sponsors, vendors and cross-functional team members. • Serve as a support escalation contact for simple systems for study-specific questions/issues