Senior Clinical Project Manager

Ora

About The Position

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 Senior Clinical Project Managers (Sr. 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 as well as overseeing other projects they are not directly managing, as a senior member of the clinical operations team, to provide support to more junior team members. Sr. 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.

Requirements

Bachelors’ degree in Life Science with at least 7 years of clinical trial experience. Years of experience may be considered in lieu of education
Minimum of 3 years of clinical project management experience.
Understanding of multi-center drug and/or device trials.
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.

Nice To Haves

Ophthalmology experience preferred.
Experience with Veeva TMF and CTMS systems.
Multi-lingual communication is a plus

Responsibilities

May manage department Clinical Project Managers, Assistant Project Managers, Clinical Trial Associates and other supporting staff.
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).
May represent Ora at professional meetings or seminars.
Participates in preparing new study budgets, proposal documents and participating in bid defenses.
Active role in department and company-wide process improvement initiatives.
Travel of up to 15% is required (mainly domestic, overnight).
Adhere to all aspects of Ora’s quality system.
Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements.
Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.
Responsibilities may differ from the above based on the specific needs of the business.

Benefits

Well Being: Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1.
Flexible PTO & Unlimited Sick Time: Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays.
Financial: Competitive salaries along with a 401K plan through Fidelity with company match.
Family Support Care: Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave.
Company Paid Life & Disability Insurance: Offering peace of mind to help you and your family feel secure.
Remote & Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases.
Employee Assistance Program: No matter what issues you're facing, New Directions is here to help you and your family.
Career Development Opportunities: Continued opportunities to grow and develop your career journey.
Global Team: Opportunities to work with colleagues across the globe.
Impact: A chance to research new ophthalmic therapies that will impact patients across the globe.