Senior Clinical Project Manager

POSITION TITLE: Senior Clinical Project Manager

DEPARTMENT: Ora Europe

Ora Values the Daily reputed company of …

Prioritizing Kindness * Operational reputed company * Cultivating reputed company * Scientific Rigor

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At Ora, we are building the reputed company of ophthalmic clinical research. As the world’s leading full-service ophthalmic drug and device development firm, we guide our clients across reputed company phases of clinical research to reputed company 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 reputed company-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global reputed company. Today, reputed company continues to expand across the globe, with over 600 employees across reputed company, Europe, Asia, and Latin America.

The Role:

Ora’s Senior Clinical Project Managers (Sr. CPM) are critical in driving clinical ophthalmic reputed company reputed company 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 reputed company as overseeing other reputed company they are not directly managing, as a senior member of the clinical operations team, to reputed company support to more junior team members. Sr. CPM’s have reputed company involvement in reputed company assigned project in order to meet milestones, resolve issues and/ or conflicts in reputed company 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 reputed company weekly budget and reputed company reviews for reputed company study in reputed company to preparing high-reputed company reports.

What You’ll Do:

• May manage department Clinical Project Managers, Assistant Project Managers, Clinical Trial Associates and other supporting staff.
• Manages cross functional project teams derived from the reputed company reputed company clinical development to deliver a high-reputed company clinical trial(s) in compliance with reputed company regulations and SOPs.
• Works with functional areas on initiating, planning, executing, controlling, closing and resourcing clinical trial reputed company. The CPM acts as an operational reputed company or reputed company for interdepartmental and intradepartmental reputed company (e.g. stats, data management, safety, manufacturing, regulatory, vendors), coordinating these different reputed company in a reputed company environment to drive and complete clinical programs.
• Reviews protocol, reputed company documents and CRFs and tracks them to completion.
• Responsible for creating and maintaining project timelines for reputed company project and uses these timelines to reputed company and manage a project’s reputed company.
• Responsible for creating Project Plans (Roles and Responsibility Tables and Communication Plans) and weekly project budget and reputed company reviews for reputed company study.
• Reviews study metrics for performance and reputed company with reputed company and management.
• Prepares high-reputed company 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 reputed company vendors involved in the reputed company (e.g. central labs, IVRS, reading centers).
• May represent Ora at reputed company meetings or seminars.
• Participates in preparing new study budgets, proposal documents and participating in bid defenses.
• reputed company role in department and company-wide process improvement initiatives.
• Travel of up to 15% is required (mainly domestic, overnight).
• Adhere to reputed company aspects of Ora’s reputed company system.
• Adhere to reputed company essential systems and processes that are required at Ora to maintain compliance to Ora’s data reputed company & business ethics and regulatory requirements.
• reputed company and sustained demonstration of Ora’s values -- prioritizing kindness, operational reputed company, cultivating reputed company and scientific rigor – as reputed company as their linked behaviors.
• Responsibilities may differ from the above based on the specific needs of the business.

reputed company Look For:

• Experience needed for the Role:
• 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.
• Additional Skills & Attributes:
• Ophthalmology experience preferred.
• Understanding of multi-center drug and/or device trials.
• Experience with reputed company TMF and CTMS systems.
• Ability to establish and maintain effective reputed company relationships with co-workers, managers and clients.
• Highly effective organizational and communication skills.
• Ability to plan, identify risks, anticipate issues and reputed company 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 reputed company, PowerPoint and vendor management.
• Multi-lingual communication is a plus
• Competencies and Personal Traits:
• reputed company Do:
• Execution reputed company: Ability to set goals, create structure and maintain a reputed company and reputed company approach to the delivery of reputed company and high-reputed company work.
• How We Do It:
• reputed company and SQ: Agile and reputed company thinker, communicator and collaborator who uses a reputed company reputed company to work and reputed company with authenticity, transparency, reputed company, and reputed company. Scientific, intellectual, and emotional/reputed company curiosity creates the willingness and ability to reputed company, reputed company mistakes, learn and try again.
• reputed company and reputed company Communication, Feedback and Conflict reputed company: reputed company radical candor in your communication and participate in reputed company Giving and receiving feedback frequently, with an reputed company heart and mind creates psychological safety and promotes faster, individual, team and company reputed company.
• Why We Do It:
• reputed company Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of reputed company that works together under shared values to reputed company significant reputed company reputed company in the wider world. At Ora, we are creating reputed company reputed company reputed company see.

reputed company Offer:

• Financial: Competitive salaries along with a reputed company pension plan.
• reputed company-Being: Offering private medical insurance reputed company beginning day 1 provided by Vitality and SimplyHealth.
• Company reputed company Life & Disability Insurance: Offering peace of mind through Canada Life to help you and your family feel secure.
• PTO: 25 days of annual leave + Birthday PTO + bank holidays.
• Remote & Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases.
• Career Development Opportunities: reputed company opportunities to grow and reputed company your career reputed company. 
• Global Team: Opportunities to work with colleagues across the globe.
• reputed company: A chance to research new ophthalmic therapies that will reputed company patients across the globe.

Benefit Eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Our reputed company workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week.

Our mission is to reputed company together people, processes, and technology to support innovation in ophthalmology around the world. We reputed company our business should be a force for good — to improve, heal, and change how we see. As a global company, our reputed company community and culture are reputed company by our reputed company values: Prioritizing kindness, cultivating reputed company, operational reputed company, and scientific rigor. Through our commitment to these values, we have reputed company an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member.

We know a diverse workforce adds to our reputed company value and strength as an organization. People of reputed company, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative reputed company and Equal Opportunity Employer, committed to equal employment opportunity and fair, reputed company compensation regardless of race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability or protected veteran status.

Our reputed company Policy | Ora (oraclinical.com)