Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. The Clinical Trial Associate (CTA) is responsible for supporting the conduct of clinical trials and handling administrative aspects of clinical trial execution. This role will support completion of all study deliverables, ensuring the highest level of data quality; proactively identifies, communicates, and resolves clinical study operational issues; and participates in process improvement initiatives as required. This role adheres to Clinical Standard Operating Procedures and Good Clinical Practice ICH Guidelines. Key Responsibilities: Perform general administrative tasks to support team members with clinical trial execution, e.g., development and formatting of documents, review and reconciliation of study- specific information, etc. - Assist in maintaining study status updates on a weekly basis. (e.g., IRB approvals, regulatory document collection, patient enrollment, monitoring status, etc.) - Track and prepare study-specific information using databases, spreadsheets, and other tools. - Review and/or approval of study documentation, including essential document packets, study plans, informed consent forms, etc. - Manage clinical and non-clinical supplies, including purchase and shipping. - Help with the development and distribution of site binders. - Set-up and coordinate meetings, take and distribute meeting minutes. - Support protocol and study-specific training with vendors, site personnel, and clinical sites. - Coordinating the movement of laboratory samples between clinical sites and central laboratories and tracking the status of samples and resulting laboratory data. - Ability to work with timelines and complete tasks according to deadline. Problem solving study-related issues; demonstrating resourcefulness and independence; escalation of issues as needed. - Should have knowledge and experience with Trial Master Files (TMF) and experience with electronic TMF systems. (i.e., Veeva) - Will assist/back-up the Clinical Regulatory Operations Specialist for overall quality, maintenance, and completeness of Trial Master Files. - Perform other duties as assigned. Knowledge, Skills, and Abilities - Foundational knowledge of clinical research and/or experience in research setting – not required but a bonus. - Exceptional organizational skills and attention to detail; able to manage multiple priorities and timelines effectively. - Strong written and verbal communication skills; ability to interact professionally within a cross-functional team environment. - Adept at learning new systems and technologies. (i.e., eTMF, CTMS, or similar platforms) - Proficient with standard office software. (Microsoft Office suite; Outlook, Excel, Word, PowerPoint) - Demonstrated ability to work independently and as a team player in a fast-paced environment. - Critical thinking and problem-solving abilities. - Ability to maintain confidentiality and adhere to high ethical standards. Professional Experience/Qualifications: - Bachelor’s degree or equivalent curriculum. (scientific or healthcare discipline preferred) - A minimum of 1 year of related experience is preferred, open to entry level candidates - Solid computer skills in Office, Word Excel, Project, Smartsheet, and other applicable applications. - Ability to work in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands. - Excellent communication and interpersonal skills are essential as the CTA interacts with many people of varying levels of responsibility for clinical trial programs. - Able to collaborate effectively with internal and external study management teams to meet project timelines. - Excellent writing skills to assist with creation of file notes, team communications, and other documents as assigned. The base salary range for this role is $72,500.00 - $90,600.00 Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law. Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Mental/Physical Requirements: Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. Travel Requirements: Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed. Drug Screening Requirements Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at reasonableaccomodations@us.sumitomo-pharma.com. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.

Freelance / Contractual, CRA with experience in Dermatology, Spain The Contractual Clinical Research Associate (cCRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. This role will be perfect for you if: - You are an experienced CRA with a demonstrated ability to work autonomously to meet quality standards and deadlines - Focusing on dermatology and developing an expertise in this therapeutic area is interesting to you - You enjoy working for a mid-sized CRO where your contributions are noticed and valued RESPONSIBILITIES The cCRA will: - Conducts site qualification, initiation, monitoring, and close-out visits for research sites according to the monitoring plan, Indero and sponsor SOPs, ICH/CGP guidelines and applicable regulations - Participates in investigators’ meetings - Prepares site visit reports and follow-up letters to the investigator - Builds productive relationships with investigators and site staff to achieve study objectives, including patient recruitment targets - Performs source data verification, ensures on-site study drug storage, dispensing, and accountability, data collection, and regulatory document collection is adequate - Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training Requirements Education - B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience Experience - 3 years of experience in conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry - At least 1 year of experience in dermatology Knowledge and skills - Good knowledge of ICH/GCP standards and applicable regulatory requirements - Strong verbal and written communication skills in English - Ability to prioritize different assignments and work under pressure while maintaining attention to detail and meeting timelines - Excellent judgement and problem-solving skills - Travel to research sites approximately 65% of the time - Excellent knowledge of Microsoft Office (i.e., Word, Excel, PowerPoint) - Experience in dermatology is an asset Our company The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. Recruitment process: what to expect - As part of the recruitment process for this position you will meet various team members at Indero - The first interview will be conducted by Teams (30 minutes) and the second via video conference (1 hour) About Indero A Global Clinical Leader In Dermatology! Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint. Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in Spain. Description de poste null Profil recherché null Notre entreprise null

Clinical Supervisor Part-Time | Fee-for-Service | Clinical Residency Program Lead. Mentor. Elevate Clinical Excellence. At Backpack Health, we’re building the next generation of exceptional behavioral health clinicians. We are seeking a Clinical Supervisor to provide high-quality supervision, mentorship, and training to residents and pre-licensed clinicians in our Clinical Residency Program. This is a part-time, fee-for-service leadership role ideal for a seasoned clinician who is passionate about developing others while staying actively engaged in clinical practice. Reporting to the Manager of the Residency Program, you will play a vital role in promoting clinical excellence, ensuring compliance with state licensure and CARF standards, and strengthening continuity of care across both in-person and telehealth services. You’ll also maintain a small caseload to model best practices and stay grounded in direct care. What You’ll Do 🧠 Clinical Supervision - Provide weekly individual and group supervision aligned with state and accreditation standards - Review and approve treatment plans, progress notes, and clinical documentation - Ensure ethical, high-quality, evidence-based care delivery 💬 Direct Clinical Care - Maintain a small, active caseload - Model person-centered, culturally responsive, evidence-based therapy - Demonstrate documentation excellence and quality assurance standards 🎓 Training & Professional Development - Co-lead resident orientation, workshops, and ongoing training sessions - Support clinicians in developing professional identity, confidence, and ethical decision-making - Foster clinical skill-building and readiness for independent licensure 📋 Documentation & Compliance - Monitor and approve resident documentation for timeliness, accuracy, and Medicaid compliance - Maintain supervision logs and training records aligned with state and CARF standards - Participate in audit readiness and quality improvement initiatives 📊 Performance Evaluation - Conduct competency-based evaluations - Develop and track individualized development plans - Provide structured, strengths-based feedback 🤝 Collaboration & Leadership - Partner with Residency Program leadership, Clinical Operations, and Quality & Compliance teams - Support cross-functional alignment and program consistency - Contribute to systems-level clinical innovation and operational excellence What You Bring - Advanced clinical degree (LCSW-C or LCPC) with unrestricted licensure in Maryland - Willingness to pursue additional cross-licensure - 4+ years of post-master’s clinical experience - 2+ years of leadership experience - Experience in virtual healthcare strategy or systems-level behavioral health transformation - Demonstrated success launching tech-enabled or digital clinical initiatives (e.g., supervision platforms, outcome dashboards, clinical content systems) - Strong knowledge of compliance, Medicaid documentation standards, and accreditation processes - Experience using data to drive performance improvement - A systems-oriented mindset with the ability to scale innovation Why Join Backpack Health? 📚 Growth & Education - CEU reimbursement - Leadership development opportunities - Advancement pathways 💜 Supportive & Collaborative Culture - Mission-driven team of clinicians and operators - Innovative, forward-thinking environment - Strong clinical community and mentorship culture 💰 Competitive Benefits - Medical, Dental & Vision Insurance - 401(k) with 3% Company Match - Paid Holidays & Generous PTO Backpack Health is an Equal Opportunity Employer. We believe that the strength of our care depends on the diversity and well-being of our team. We celebrate differences in age, color, disability, ethnicity, gender identity or expression, national origin, physical and mental ability, race, religion, sexual orientation, veteran status, and other traits that make each person unique. We welcome and encourage diverse candidates to apply for any position for which they are qualified and to bring their unique perspectives, experiences, and talents to our team.

Clinical Supervisor Part-Time | Fee-for-Service | Clinical Residency Program Lead. Mentor. Elevate Clinical Excellence. At Backpack Health, we’re building the next generation of exceptional behavioral health clinicians. We are seeking a Clinical Supervisor to provide high-quality supervision, mentorship, and training to residents and pre-licensed clinicians in our Clinical Residency Program. This is a part-time, fee-for-service leadership role ideal for a seasoned clinician who is passionate about developing others while staying actively engaged in clinical practice. Reporting to the Manager of the Residency Program, you will play a vital role in promoting clinical excellence, ensuring compliance with state licensure and CARF standards, and strengthening continuity of care across both in-person and telehealth services. You’ll also maintain a small caseload to model best practices and stay grounded in direct care. What You’ll Do 🧠 Clinical Supervision - Provide weekly individual and group supervision aligned with state and accreditation standards - Review and approve treatment plans, progress notes, and clinical documentation - Ensure ethical, high-quality, evidence-based care delivery 💬 Direct Clinical Care - Maintain a small, active caseload - Model person-centered, culturally responsive, evidence-based therapy - Demonstrate documentation excellence and quality assurance standards 🎓 Training & Professional Development - Co-lead resident orientation, workshops, and ongoing training sessions - Support clinicians in developing professional identity, confidence, and ethical decision-making - Foster clinical skill-building and readiness for independent licensure 📋 Documentation & Compliance - Monitor and approve resident documentation for timeliness, accuracy, and Medicaid compliance - Maintain supervision logs and training records aligned with state and CARF standards - Participate in audit readiness and quality improvement initiatives 📊 Performance Evaluation - Conduct competency-based evaluations - Develop and track individualized development plans - Provide structured, strengths-based feedback 🤝 Collaboration & Leadership - Partner with Residency Program leadership, Clinical Operations, and Quality & Compliance teams - Support cross-functional alignment and program consistency - Contribute to systems-level clinical innovation and operational excellence What You Bring - Advanced clinical degree (LCSW-C or LCPC) with unrestricted licensure in Michigan - Willingness to pursue additional cross-licensure - 4+ years of post-master’s clinical experience - 2+ years of leadership experience - Experience in virtual healthcare strategy or systems-level behavioral health transformation - Demonstrated success launching tech-enabled or digital clinical initiatives (e.g., supervision platforms, outcome dashboards, clinical content systems) - Strong knowledge of compliance, Medicaid documentation standards, and accreditation processes - Experience using data to drive performance improvement - A systems-oriented mindset with the ability to scale innovation Why Join Backpack Health? 📚 Growth & Education - CEU reimbursement - Leadership development opportunities - Advancement pathways 💜 Supportive & Collaborative Culture - Mission-driven team of clinicians and operators - Innovative, forward-thinking environment - Strong clinical community and mentorship culture 💰 Competitive Benefits - Medical, Dental & Vision Insurance (full-time employees only) - 401(k) with 3% Company Match - Paid Holidays & Generous PTO Backpack Health is an Equal Opportunity Employer. We believe that the strength of our care depends on the diversity and well-being of our team. We celebrate differences in age, color, disability, ethnicity, gender identity or expression, national origin, physical and mental ability, race, religion, sexual orientation, veteran status, and other traits that make each person unique. We welcome and encourage diverse candidates to apply for any position for which they are qualified and to bring their unique perspectives, experiences, and talents to our team.