DEPARTMENT / UNIT NAME : Medical R&D
JOB SUMMARY :
As a service, product, functional and / or therapeutic area Specialist acting as the primary Sponsor / Client project liaison and advocate is responsible to plan, execute, manage and monitor complex, multinational clinical research project(s), for multiple modalities or in different therapeutic areas.
Develop, implement, monitor and be accountable for project protocols, operational plans, risk management, resources, project tools / materials, documents and timelines, ensuring alignment with corporate, industry, sponsor and regulatory requirements.
Assist the Project Director in the development and execution of quality improvement processes / activities and provide support to Business Development and Research and Development, representing the organization at meetings, events, conferences and presentations as required.
Senior Project Managers are expected to be primarily accountable for the success of the projects they are leading.
AREAS OF RESPONSIBILITY :
Manage the planning, execution, progress and completion of assigned clinical research projects
Working with functional experts ensure all project activities comply with applicable regulations, guidelines, and corporate policies
Maintain operational, financial and regulatory integrity and accountability.
Develop and / or participate in the development of project communications, training, regulatory submissions and / or audits and selection of third party vendors as required.
Define and manage project resource needs and establish contingency plans for key resources.
Review costs and time spent on project on a regular basis to ensure they are in line with the scope of work.
Implement measures to meet financial performance targets for the assigned clinical projects as required
Documents and Tools
Manage a cross-functional team, which can include unit peers and / or subordinates, and subcontractors to ensure the appropriate creation, delivery, maintenance and disposal of all related data, documents, equipment and tools, including protocols, SOPs, informed consent forms, case report forms and instructions.
Prepare investigator updates and other project related reports as required to support the proper conduct and execution throughout the life cycle of assigned projects.
Project Team Performance
Identify, assign and monitor the completion of interdisciplinary project tasks.
Promote effective teamwork among project team members, ensure effective conflict resolution.
Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects.
Ensure that staff allocated to assigned project adheres to professional standards and SOPs established for clinical research.
Lead, motivate and coordinate teams and mentor / coach team members as appropriate.
Delegate effectively and prioritize own and project team members workload.
Client / Sponsor Support
As the project lead, will act as primary liaison throughout the project life cycle ensuring client / sponsor expectations appropriately managed;
addressing and resolving queries / issues, planning and executing all project meetings, assisting with site and patient recruitment strategies and materials, assisting with the development of stakeholder training and by regularly providing sponsor / client with project status and update reports.
Manage project budget and initiate, review and negotiate changes to study budgets with sponsor.
Service / Functional or Therapeutic Specialist
Act as a peer mentor, delivering new CPM orientation, provide peer training, coaching and / or ongoing advice on project and sponsor related issues to peers and subordinates, contribute to performance evaluation process and act as first point of escalation for sponsors and sites on pre-assigned projects.
Assist with development, preparation and / or testing of project proposals, bid defenses, budgets, new product / service template development as required.
Applicants should have a minimum of a college diploma / degree and 3-5 years of relevant experience + substantial on-going training.
The ideal candidate will possess significant and progressive experience in the management of global, multi-centre, investigator-initiated clinical trials.
The successful individual will demonstrate exceptional communication and time management skills. Knowledge of gastroenterology is considered an asset.
WORKING CONDITIONS : Home-based
Accommodations for job applicants with disabilities are available upon request