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Canada Pharmaceutical Research Associates, Inc Full timeJob Title: Clinical Study ManagerAt ICON plc, we're committed to fostering an inclusive environment that drives innovation and excellence. We're seeking a highly skilled Clinical Study Manager to join our team and contribute to our mission to shape the future of clinical development.Key Responsibilities:Lead and coordinate cross-functional study teams to...
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Clinical Study Delivery Specialist
2 months ago
At ICON Strategic Solutions, we are seeking a highly skilled Study Delivery Specialist to join our Global Study Team. As a key member of our team, you will play a critical role in delivering clinical studies to time, cost, and quality, ensuring inspection readiness by overseeing study eTMF completeness.
Key Responsibilities:- Collaborate with the Study Manager and/or Study Delivery Lead on end-to-end operational study delivery activities, from study setup to study archival, focusing on setting up, maintaining, and ensuring completeness of internal systems, databases, tracking tools, and project plans.
- Work cross-functionally with internal and external partners on clinical study management activities, as agreed with the Study Delivery Lead, for in-house and outsourced studies across all phases and therapeutic areas, in accordance with the Study Team Operating Model, current clinical study regulations, and procedures.
- Monitor study conduct and progress, identifying, resolving, and escalating risks/issues that may impact delivery of the study to the necessary quality, timeline, and budget objectives.
- Review key clinical documents, including the Protocol and Informed Consent Forms, and lead the development of study plans (e.g., Monitoring Plan, Vendor Management Plan, Protocol Deviation Management Plan, Risk Management Plan, Communication Plan) for external and internal use in assigned studies.
- Facilitate and maintain interactions and meetings with internal (regulatory, LOC, quality assurance, Monitors meeting) and external partners (CROs and third-party vendors) to ensure the successful delivery of assigned studies.
- Manage vendor relationships and CRO oversight, acting as a primary point of contact, overseeing study-specific deliverables, ensuring continued monitoring, and timely delivery of activities delegated to third parties.
- Oversee country operations, acting as a primary point of contact, tracking recruitment progress, data completeness, and compliance, overseeing local budgets, protocol deviations, risks, regulatory approvals, and import license status.
- Coordinate study-related activities and manage study team communication – meetings (preparation, scheduling, meeting minutes), infospaces, newsletters, action logs, communication plans, team lists.
- Oversee the delivery of clinical supplies, investigational products, and all study materials provided by the client or external service providers and communicate issues/risks to continuity of supplies and propose solutions as appropriate.
- Ensure data oversight to guarantee the study is inspection-ready at all times, including oversight of eTMF completeness (eTMF setup, periodic reviews, following up on missing documents, Safety Reports Dissemination), and assure that all eTMF documents are complete and verified for quality.
- Manage budget oversight – managing Task/Change Orders, expenses, tracking updates, checking consistency between systems and agreements, and escalating issues to the SDL.
- Contribute to the squad as per Study Team Operating Model requirements.
- Graduate/Bachelor's degree in life sciences or other related field.
- At least 1+ years of relevant work experience in a pharmaceutical/scientific environment.
- Scientific background and knowledge of clinical trials (including ICH-GCP) and drug development process is an asset.
- Foundational knowledge of clinical study delivery process, including regulations, operational best practices, industry standards. Well familiar with key systems used in clinical trial delivery. Experience in using Trial Master File industry-accepted standard.
- Strong project management skills (preferably with analytical/financial skills).
- Excellent verbal and written communication.
- Excellent communication and relationship-building skills.
- Good knowledge of, and skills in applying, applicable clinical trial regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
- Ability to manage multiple competing priorities within various clinical studies with good planning, time management, and prioritization skills.
- Ability to think independently, analyze and solve problems systematically and creatively, and to take a risk-based approach.
- Logical/analytical thinking and an inclination to spot patterns and outliers. Quality mindset, critical sense, attention to details, effective training skills.
- Good understanding of the principles of project planning and project management.
- Basic knowledge of project finance and accounting principles in order to understand budget, invoices, cross-charges, and expense reports.
- Very good comprehension of Microsoft Office tools (Excel, PowerPoint, Word, Outlook, etc.). Knowledge of advanced Excel, timelines/budget tracking systems, and clinical trial management systems is an asset.
- Excellent stakeholder management and communication skills (oral and written), outstanding interpersonal skills.
- Results-driven and efficient. Motivated and dynamic personality. Able to evolve in a changing and challenging environment.
- Ability to adjust to work in cross-functional squads in the agile model.
- Role model in line with client core values and expectations. Team spirit and ability to work across cultures and geographies with a high awareness and understanding of cultural differences.
