Ora

• Responsible for assisting the Regulatory submissions team in QC, coordination of document preparation, management, and submissions within (and around) Europe. • Performs the role of a Regulatory Lead for studies primarily within the European region during study start-up until study close out. • Oversees and performs quality control checks on clinical and regulatory documents, including Patient Information Sheet (PIS)/Informed Consent Form (ICF). • Responsible for and contributes to preparation and submission of documents to regulatory authorities and ethics committees, primarily within the Clinical Trial Information System (CTIS) and other submissions portal(s), as required. • Performs quality control checks on study documents that are received from the sponsor and/or prepared by country CRAs to ensure all submission documents meet Ora's submission standards. • Oversees, coordinates and contributes to development of country adapted study documents and ensuring documents are sponsor approved prior to finalisation. • Contributes to the review and revision of standard operating procedures (SOPs), templates, and forms. • Performs data entry for tracking of regulatory submission activities. • Updates tracking logs, databases, and ensure filing of country adapted and sponsor approved study documents are filed in collaborative workspace. • Prepares the clinical trial application within CTIS with supervision; in compliance with forecasted timelines. • Escalates potential issues identified to impact forecasted timelines quickly. • May be required to provide regulatory support in other regions. • Keep up to date with current regulations, guidelines and changes in the industry. • Collaboration with Global Regulatory team and wider stakeholders. • 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.

Role Description Ora’s Clinical Documentation Management Specialists II (CDMS II) is responsible for the management, quality and oversight of the electronic Trial Master File (eTMF) associated with all phases of assigned clinical trials (i.e., set-up through final transfer / archival). CDMS II’s are crucial for ensuring Ora’s clinical teams operate in compliance with SOPs and processes, study sponsor expectations and all applicable regulations. This role will focus on the quality of documents being uploaded to the eTMF and monitoring compliance to the TMF relative to inspection readiness and handle such issues independently and with oversight for escalations as needed. Additionally, our CDMS II’s have the responsibility of preparing documentation required for regulatory agency inspections and internal audits. This role reports directly to the Manager while working in collaboration with various clinical study teams such as Quality Assurance, Chemical Manufacturing Control, and Medical Devices. Ora’s CDMS II’s will train to become Veeva Vault Super Users and be responsible for providing support and training to more junior team members, identify process improvements, handle escalations for documentation resolutions. What You’ll Do - Implement and administer Ora document management systems (Veeva Vault) and related procedures. - Manage documentation to ensure organization and accuracy. - Ensure clinical records are filed in a timely manner. - Perform quality-control (QC) review of clinical and regulatory documents submitted for entry into the eTMF. - Assist with the development of work processes and systems to support document management. - Train towards and actively serve as a Veeva Vault Super-user. - Develop and present training materials to educate trial team staff and CDMS I’s. - Assist the clinical team in the close-out and archiving of clinical documentation and reports. - Process and fulfill document requests from internal and external stakeholders. - Generate/review metrics reports intended as periodic review of study files for completeness. - Identify and classify documents or other electronic content. - Prepare and record changes to eTMF documents. - Assist in the development of document or content classification taxonomies. - Assist in the preparation of support documentation and training materials for end users. - Support assigned TMF corrective action plans. - Clear and sustained demonstration of the Ora Clinical’s Values. - Travel Requirements less than 10%. - Adhere to all aspects of Ora’s quality system. Qualifications - Bachelor’s degree with a minimum of 3 years’ experience with clinical documentation. - 3 years’ experience with record management systems (eTMF) in the clinical research field or equivalent combination of work experience, education, and training. Requirements - Prior experience with Veeva Vault, Montrium, Master Control, Documentum, Box is strongly preferred. - Familiarity with ICH GCP, DIA TMF Reference Model and regulatory guidelines/directives. - Familiarity with eTMF and CTMS software for document management activities. - Prior experience working in a CRO environment. - Familiarity with various aspects of clinical trials and regulatory submissions. - Detailed knowledge of regulatory requirements and ICH/GCP guidelines. - Demonstrated ability to work independently, take initiative, and mentor other team members. - Requires strong attention to detail and document organization skills. - Ability to communicate at multiple levels both internally and externally. - Multi-lingual communication is a plus. Benefits - Comprehensive healthcare options in Medical, Dental and Vision beginning day 1. - Flexible PTO & Unlimited Sick Time. - Competitive salaries along with a 401K plan through Fidelity with company match. - Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave. - Company Paid Life & Disability Insurance. - Remote & Wellness Reimbursement. - Employee Assistance Program. - Continued opportunities to grow and develop your career journey. - Opportunities to work with colleagues across the globe. - A chance to research new ophthalmic therapies that will impact patients across the globe.

• Develop strong site relationships and ensures continuity of site relationships through all phases of the trial. • Performs, with oversight, clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. • Gain in-depth understanding of the study protocol and related procedures. • Coordinate & manage various tasks in collaboration with other internal roles to achieve Site Readiness. • Participate & provide input on site selection and validation activities. • Perform remote and on-site monitoring & oversight activities using various tools to ensure: • Data generated at site are complete, accurate and unbiased • Subjects’ right, safety and well-being are protected. • Conducts site visits including but not limited to evaluation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. • Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out. • Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. • Identify, assess and resolve site performance, quality or compliance problems and escalates as appropriate in collaboration with Clinical Research Lead and CRA line manager. • Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. • Supports audit/inspection activities as needed. • Travel Requirements up to 75%. • Adhere to all aspects of Ora’s quality system. • Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.

• Develop strong site relationships and ensures continuity of site relationships through all phases of the trial. • Performs, with oversight, clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. • Gain in-depth understanding of the study protocol and related procedures. • Coordinate & manage various tasks in collaboration with other internal roles to achieve Site Readiness. • Participate & provide input on site selection and validation activities. • Perform remote and on-site monitoring & oversight activities using various tools to ensure: • Data generated at site are complete, accurate and unbiased. • Subjects’ right, safety and well-being are protected. • Conducts site visits including but not limited to evaluation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. • Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out. • Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. • Identify, assess and resolve site performance, quality or compliance problems and escalates as appropriate in collaboration with Clinical Research Lead and CRA line manager. • Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. • Supports audit/inspection activities as needed. • Travel Requirements up to 75%. • 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.

• Develop strong site relationships and ensures continuity of site relationships through all phases of the trial. • Performs, with oversight, clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. • Gain in-depth understanding of the study protocol and related procedures. • Coordinate & manage various tasks in collaboration with other internal roles to achieve Site Readiness. • Participate & provide input on site selection and validation activities. • Perform remote and on-site monitoring & oversight activities using various tools to ensure: • Data generated at site are complete, accurate and unbiased. • Subjects’ right, safety and well-being are protected. • Conducts site visits including but not limited to evaluation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. • Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out. • Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. • Identify, assess and resolve site performance, quality or compliance problems and escalates as appropriate in collaboration with Clinical Research Lead and CRA line manager. • Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. • Supports audit/inspection activities as needed. • Travel Requirements up to 75%.

• Develop strong site relationships and ensures continuity of site relationships through all phases of the trial. • Performs, with oversight, clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. • Gain in-depth understanding of the study protocol and related procedures. • Coordinate & manage various tasks in collaboration with other internal roles to achieve Site Readiness. • Participate & provide input on site selection and validation activities. • Perform remote and on-site monitoring & oversight activities using various tools to ensure: • Data generated at site are complete, accurate and unbiased • Subjects’ right, safety and well-being are protected • Conducts site visits including but not limited to evaluation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. • Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out. • Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. • Identify, assess and resolve site performance, quality or compliance problems and escalates as appropriate in collaboration with Clinical Research Lead and CRA line manager. • Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. • Supports audit/inspection activities as needed. • Travel Requirements up to 75%. • 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.

• 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. • 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.

• 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. • 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. • Clear and sustained demonstration of Ora’s values.

• 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.

• 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. • Provide support to more junior team members. • Responsible for creating project plans and provide weekly budget and progress reviews for each study. • Prepare high-quality reports. • Ensures review of clinical electronic Trial Master File (eTMF) for completeness. • Manages and coordinates all vendors involved in the clinical trials. • Active role in department and company-wide process improvement initiatives.