Ubicación: Madrid, Madrid provincia
Descripción completa del empleo: POSITION TITLE: Clinical Project Manager
DEPARTMENT: Ora Europe
LOCATION: Remote, Spain
Ora Values the Daily Practice of …
Prioritizing Kindness Operational Excellence Cultivating Joy Scientific Rigor At Ora, we are building the future of ophthalmic clinical research.
As the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market.
Over the past 45 years, our expert teams have helped earn more than 85 new product approvals.
Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects.
Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America.
The Role: Ora's Clinical Project Managers (CPM) are critical in driving clinical ophthalmic projects forward utilizing best practices in order to ensure budgets, timelines, and clinical trial requirements are being met on behalf of the sponsor.
This role will work independently to manage cross-functional project teams.
CPM's have active involvement in each assigned project in order to meet milestones, resolve issues and/or conflicts in addition to frequent interactions with the study team including but not limited to clinical trial associates, monitoring, clinical research coordinators, investigators, and senior management.
They are responsible for creating project plans and providing weekly budget and progress reviews for each study in addition to preparing high-quality reports.
What You'll Do: Manage cross-functional project teams derived from the groups within clinical development to deliver high-quality clinical trial(s) in compliance with all regulations and SOPs. Work with functional areas on initiating, planning, executing, controlling, closing, and resourcing clinical trial projects. Act as an operational nexus or focal point for interdepartmental and intradepartmental groups (e.g.
stats, data management, safety, manufacturing, regulatory, vendors), coordinating these different groups in a matrix environment to drive and complete clinical programs. Review protocol, source documents, and CRFs and track them to completion. Create and maintain project timelines for each project and use these timelines to track and manage a project's progress. Create Project Plans (Roles and Responsibility Tables and Communication Plans) and weekly project budget and progress reviews for each study. Review study metrics for performance and quality with the team and management. Prepare high-quality reports (financial, project, etc.)
for management on program status and issues.
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