• Develop statistical methodologies, protocols, and sample size calculations for pre-market and post-market clinical studies. • Plan methods to collect data and develop or review case report forms to ensure compatibility with plan design. • Evaluate reliability and validity of source information, apply weightings to raw data, and organize results in form appropriate to software requirements. • Designs clinical trials, analyzes study data to validate device safety and efficacy, and creates Statistical Analysis Plans (SAPs). • Perform advanced statistical analyses using appropriate methodologies. • Interpret results and provide strategic insights. • Review clinical literature and analyze Real-World Evidence (RWE) to set performance goals. • Write reports summarizing trial outcome statistics, indicating sources of data and limits on reliability and usability, for in-house, regulatory and publication target audiences. • Prepare statistical reports for regulatory submissions (FDA, CE Mark, other regulatory authorities like TUV) and address regulatory inquiries. • Performs analysis and generates visual/tabular data for scientific presentations and publications. • Collaborate with cross-functional team members (clinical affairs, data management, pre-clinical and R&D engineers) to define endpoints, analyze safety reporting, and prepare for submissions.to ensure data integrity and accurate analyses. • Develop statistical tables and data summaries as needed. • Review project database structures, edit checks and data management coding conventions. • Ensure compliance with industry standards and guidelines. • May attend relevant scientific and/or medical meetings. • Support publication of study findings.

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.

Role Description ADTRAV is seeking a Travel Coordinator to support Leisure Travel Agents and management with different aspects of the reservation and reporting process for a dedicated client account. The Travel Coordinator will act as a main point of contact for the client and ensure we are meeting client expectations. - Provide support to the Leisure Agents to ensure ADTRAV meets the service levels expected by our client. - Oversee email inbox for team and ensure emails are responded to promptly and professionally. - Assist in answering the main phone line for team during business hours. - Conduct welcome calls for new orders. - Assign clients to agents as received and update tasks for new consults scheduled and update the CRM stage accordingly. - Monitor SLA requirements and work with agents to update files and CRM. - Schedule military travels to include air, hotel, and dinner reservations. - Ensure travel details are entered correctly by agents and do research in Sabre to handle customer service issues. - Assist with training agents on client processes, procedures, and SLA requirements. - Meet all KPIs as required for the position. - Create, maintain, and generate daily, weekly, and monthly reports for management and client contacts (e.g., KPI, SLA). - Utilize a variety of tools and applications, including Sabre, HubSpot, Smartsheet, Confluence, Jira, Microsoft Office, and internal systems, to support daily responsibilities. - Become knowledgeable in ADTRAV's industry and customer base. - Participate in ongoing training to continuously build knowledge and skills in the industry. - Represent ADTRAV by embracing the company values and maintaining effective working relationships with employees, partners, vendors, and clients. - Adhere to company policies and procedures. - Other duties as assigned. Qualifications - High school diploma or equivalent required. - At least 1-2 years of experience in a support/administrative role. - At least one year experience in the leisure/Corporate travel industry and with Sabre GDS required. - Strong computer and typing skills, which includes the ability to navigate quickly between programs and using shortcut keys. - Demonstrated experience learning and using technology, and ability to use multiple applications and monitors at one time. - Strong customer service orientation with proven ability to establish and develop relationships. - Proficient with Microsoft Office suite (Outlook, Word, Excel, Teams). - Experience using a CRM to enter and track activities preferred. - Excellent English written and verbal communication skills. - Highly proficient in business writing and able to format emails and communication with proper grammar and spelling. - Strong attention to detail with emphasis on accuracy and quality. - Highly self-motivated and able to manage multiple tasks in a fast-paced environment and with minimal supervision. - Able to respond quickly in a dynamic and changing environment. - Strong analytical and critical thinking skills. - Excellent time-management and organizational skills, with a proven ability to meet deadlines and work well under pressure. - Ability to communicate ideas and concepts clearly and concisely, while also being open to receiving feedback and direction as needed. - Able to present a professional and positive demeanor with internal and external customers/clients and work cooperatively. - Ability to work remotely and meet the company home-office requirements. - Able to sit and work at a computer for extended periods of time, without leaving the work area. - Able to work a schedule that falls between Monday-Friday, 7am-7pm CT, as well as after hours, weekends, and holidays as needed. - Able to maintain confidentiality of company and client information. - Able to successfully pass a credit, criminal, and/or employment reference background check. Requirements - The pay range for this position is $22-25/hour, depending on qualifications. Benefits - ADTRAV offers a competitive benefits package that includes medical, dental, vision, life, disability, Flexible Spending Accounts, 401(k), and PTO.

Sr. Clinical Trial Coordinator - FSP Client Dedicated Location: Romania Full time Remote As part of our global team, you’ll have the opportunity to provide administrative and technical support to the Project Team. As a Senior Clinical Trial Coordinator, you'll coordinate and facilitate project activities and may serve as a study lead, acting as a cross-functional liaison for the project team. You will act as a buddy during the onboarding phase and provide training to new staff as needed. Additionally, you will support departmental and cross-functional initiatives for process improvements and enhancements. What You’ll Do: • According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix. • Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system. • Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads and line manager as appropriate. • Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers including but not limited to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system. • Provides system support (i.e. GoBalto & eTMF). • Supports RBM activities. • Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members. • Supports scheduling and organization of client and/or internal meetings with completion of related meeting minutes. • Reviews and tracks local regulatory documents. • Transmits documents to client and centralized IRB/IEC. • Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation. • Maintains vendor trackers. • Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites. • Assists with study-specific translation materials and translation QC upon request. • May attend Kick off meeting and take notes when required. Education and Experience Requirements: • High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification. • Bachelor's degree preferred with education in medical or biological sciences or discipline associated with clinical research preferred • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: • Ability to work in a team or independently as required • Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively • Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency • Strong customer focus • Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines • Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout • Excellent English language and grammar skills and proficient local language skills as needed • Good presentation skills • Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems • Ability to successfully complete PPD clinical training program • Self-motivated, positive attitude with effective strong interpersonal skills