.POSITION TITLE: Associate Clinical Project Manager DEPARTMENT: Ora Europe LOCATION: Remote, UK, Spain, Italy or Poland 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.
The Role: Ora's Associate Clinical Project Managers (Associate 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 and with oversight as needed to manage cross-functional project teams.
Associate CPM's have active involvement in each assigned project to meet milestones, resolve issues and/or conflicts, and have 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, with direction, and providing weekly budget and progress reviews for each study in addition to preparing high-quality reports.
What You'll Do: Independently and with oversight as needed manages 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.
Works with functional areas on initiating, planning, executing, controlling, closing, and resourcing clinical trial projects.
Acts 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.
Independently and with oversight as needed, reviews protocol, source documents, and CRFs and tracks them to completion.
With oversight, responsible for creating and maintaining project timelines and using these timelines to track and manage a project's progress.
Responsible for creating Project Plans, with direction from senior leadership (Roles and Responsibility Tables and Communication Plans) and weekly project budget and progress reviews for each study.
Reviews study metrics for performance and quality with the team and management.
Prepares high-quality reports (financial, project, etc.)
for management on program status and issues