Clinical Project Manager – Ophthalmology
At SRG, we create meaningful connections that empower individuals and businesses to shape tomorrow’s world.
Working as part of the SRG team, you will work with our client which are Pharmaceutical or Bio-Pharmaceutical companies to ensure work quality and accuracy for our client in the Bio Pharmaceutical Industry.
We are seeking 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 provide weekly budget and progress reviews for each study in addition to preparing high-quality reports.
- Manages cross functional project teams derived from the groups within clinical development to deliver a 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. The CPM 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.
- Reviews protocol, source documents and CRFs and tracks them to completion.
- Responsible for creating and maintaining project timelines for each project and uses these timelines to track and manage a project’s progress.
- Responsible for creating Project Plans (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.
- Ensures review of clinical electronic Trial Master File (eTMF) for completeness.
- Manages and coordinates all vendors involved in the clinical trials (e.g. central labs, IVRS, reading centers).
- Travel of up to 15% is required (mainly domestic, overnight).
- Bachelor's degree in Life Science with at least 5 years of clinical trial experience. Years of experience may be considered in lieu or education.
- Minimum of 1 year of clinical project management experience
ADDITIONAL SKILLS and ATTRIBUTES:
- Ophthalmology experience preferred.
- Understanding of multi-center drug and/or device trials.
- Experience with Veeva TMF and CTMS systems.
- Ability to establish and maintain effective professional relationships with co-workers, managers and clients.
- Highly effective organizational and communication skills.
- Ability to plan, identify risks, anticipate issues and outcomes and respond strategically, tactically and operationally while balancing short-term and long-term company objectives.
- Demonstrated expertise of applicable regulatory requirements and GCP.
- Demonstrated leadership skills and the ability to multitask and to solve problems proactively.
- Proficiency with Excel, PowerPoint and vendor management.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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