Role Description Für unseren Kunden, ein innovatives und forschendes Pharmaunternehmen mit Sitz in Ingelheim, suchen wir einen Junior CPT Specialist (m/w/d) in Vollzeit! - Durchführung von Chargenreviews - Review der Master Batch Records für den Verpackungsprozess - Durchführung vereinfachter Untersuchungen im Zuge von Marktreklamationen - Erstellung und Durchführung von Mitarbeiterschulungen - Erstellung von Standardarbeitsanweisungen Qualifications - Abgeschlossenes naturwissenschaftliches Studium (Bachelor oder Master) im Bereich Biologie, Industrielle Biotechnologie, Chemie, Pharmazie oder eine abgeschlossene naturwissenschaftliche Ausbildung als BTA, CTA, MTA, Pharmakant (m/w/d) mit mehrjähriger Berufserfahrung - Erfahrung in der pharmazeutischen Industrie von Vorteil - Gute PC-Kenntnisse - Sehr gute Deutsch- sowie gute Englischkenntnisse Benefits - I.d.R. einen unbefristeten Arbeitsvertrag - Sonderzahlungen wie Urlaubs- und Weihnachtsgeld - Ab 25 bis 30 Tage Urlaub pro Jahr - Außertarifliche Zuschläge + Prämie - 37,5 Std./Woche Vollzeittätigkeit - Bezahlung nach GVP-Tarif und auf Grundlage des Tarifvertrages der chemischen Industrie Baden-Württemberg - Schutz- und Arbeitskleidung werden kostenfrei gestellt - Kostenfreie Arbeitsmedizinischer Vorsorgeuntersuchung - Ermäßigter Zugang zu Sport-, Freizeit- und Wellness-Einrichtungen - Besondere Konditionen für den Kauf von Konzertkarten, Sportartikeln, elektronischen Geräten, Reisen und vielem mehr - Vermögenswirksame Leistungen nach der Probezeit

• Drive product development that involves Data and AI (traditional AI, GenAI and Agentic AI), leading the creation of products that are critical to our clients' businesses • Lean on your deep client services experience to drive effective decision-making on complex issues of scope, design, architecture, and process • Deliver timely, tailored communication for various audiences: engineering teams, product managers, marketing partners, and C-level executives • Create, guide, and communicate the holistic (WillowTree, client, 3rd party) project plan and goals to create alignment and drive convergent implementation • Encourage sustainable flow for your team while focusing on key client objectives • Be flexible and adaptive to changing scenarios and environments by applying appropriate project management frameworks to suit the customer and product • Regularly visit your client, usually 1-3 days per month, up to 20% of the time during kickoff or launch periods • Engage directly with clients managing the account details, project scope, and relationship

Role Description The Clinical Trial Manager will support the Company's clinical trial activities. This position reports to the Director of Clinical Operations and will be responsible for management of the day-to-day operations of one or more phase 1-3 clinical trials including trial start-up, conduct, and close-out activities. This position may support unmasked activities. Major Duties & Responsibilities - Trial Management: - Serve as the primary unmasked contact for managing protocol execution, including oversight of the unmasked CRO, other study service providers, and consultants involved in a clinical trial. - Serve as the primary sponsor-side unmasked contact for unmasked investigative site personnel. - Support unmasked drug supply and accountability activities including oversight of IWRS system. - Act as the unmasked liaison between Clinical Operations and Clinical Supply. - Support establishment of study milestones and ensure accurate tracking and reporting of study metrics and timelines to leadership. - Ensure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs. - Assist in preparation and review of clinical trial documentation such as protocol, informed consent, Investigator Brochure, Clinical Monitoring Plan, Project Plan, Case Report Forms, Statistical Analysis Plan, Clinical Study Reports, and other study-level documents. - Ensure the unmasked Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews. - Participate and coordinate resolution of audit findings and ensure audit-ready condition of clinical trial documentation including central clinical files. - Proactively identify, with the support and guidance from Senior Clinical Operations staff, and support development of plans and resolution of project issues and participate in process improvement initiatives as required. - Conduct unmasked study-specific training of CRO study staff, monitors, investigational sites, and service providers. - Perform and manage IP data review process on an ongoing basis. - Perform site visits including site qualification, initiation, monitoring, and close-out visits, as needed. - Oversee outsourced monitoring by reviewing unmasked monitoring reports to ensure quality and resolution of site-related issues. - Ensure tracking and review of protocol deviations and assess impact on study data. - Develop and manage study budget and maintain within financial goals; review and approve clinical invoices against approved budget. - Provide oversight for forecasting of clinical supplies, including study drug and supplies. - Department Management: - May manage and/or oversee work of junior Clinical Operations staff. - May support development and review of Clinical SOPs and other department initiatives. - Travel as needed to sites, conferences, and industry meetings. - Other duties as may be assigned. Qualifications - B.A./B.S. degree. - 6+ years of clinical research experience within the Biotech or similar industry, with at least 2 years directly supporting clinical trial management. - Knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trial management. - Strong clinical study management skills. - Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy, and other business partners. - Proven clinical operational skills to direct protocol execution to ensure timeline, budget, and quality metrics are met. - Excellent communication skills to effectively disseminate information to project team and outside parties. - Experience reviewing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management. - Clinical research knowledge and cross-functional understanding of clinical trial methodology. - Excellent organizational, conflict resolution, prioritization, and negotiation skills. - Proven ability in creative problem-solving and exercising sound judgment. - Team-oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners. - Ability to handle a high volume of highly complex tasks within a given timeline. - Ability to develop Therapeutic Areas knowledge and expertise through internal training and external conference attendance. - Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and Outlook. - Working knowledge of MS Project for development and update of clinical study timelines. Requirements - Travel: 5%. Physical Requirements and Working Conditions - Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word. - Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met. - Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work). Compensation Base salary compensation range: $150,000 - 170,000. Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience. Equal Employment Opportunity 4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial, and local laws. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.

• Serve as a Registered Nurse on our Maine team, supporting family caregivers and ensuring high-quality in-home care delivery • Conduct initial in-home visits prior to the start of caregiving services • Review and implement the Authorized Plan of Care provided by the state’s Assessing Services Agency • Provide on-site supervision to caregivers at least monthly for the first three months of each families’ enrollment in the program, with supervisory visits every 3-6 months thereafter • Maintain accurate clinical documentation and ensure EVV (Electronic Visit Verification) compliance • Continue initial and supervisory home visits for new and existing patients • Train and evaluate caregiver competency and conduct annual performance reviews • Monitor patient health status and coordinate with the service coordination agencies / physicians regarding significant changes • Ensure ongoing compliance with documentation standards and EVV requirements