Mallinckrodt Pharmaceuticals एक वैश्विक जैव-फार्मास्युटिकल कंपनी है, जो जटिल स्वास्थ्य स्थितियों वाले रोगियों के लिए दवाओं के विकास और आपूर्ति पर केंद्रित है। इसके फार्मास्युटिकल पोर्टफोलियो में दर्द प्रबंधन और ऑटोइम्यून विकारों से संबंधित उपचार शामिल हैं। कंपनी का कार्य अधूरी चिकित्सा आवश्यकताओं को पूरा करने और रोगी देखभाल में सहयोग देने पर केंद्रित है। 1867 में स्थापित यह कंपनी स्वास्थ्य सेवा, विनिर्माण और फार्मास्युटिकल क्षेत्रों में कार्य करती है।
Associate Clinical Trial Manager (Hybrid - Malvern, PA)
Supports cross-functional clinical research studies by coordinating vendors, sites, data, budgets, timelines, and regulatory compliance.
विवरण
- Support the Clinical Trial Manager in leading cross-functional study teams
- Oversee study start-up, execution, close-out, and vendor activities
- Manage assigned budgets, timelines, risks, quality standards, and deliverables
- Maintain the study Trial Master File (TMF)
- Assist with selecting, contracting, and overseeing CROs and clinical trial vendors
- Coordinate activities with CROs, laboratories, and other external providers
- Track vendor performance, costs, timelines, deliverables, and quality
- Create study execution and risk management plans
- Contribute to protocol, informed consent, study manual, monitoring plan, and regulatory document development
- Help select investigative sites and monitor GCP and ICH compliance
- Conduct EDC and IRT user acceptance testing and review EDC metrics
- Support investigator meetings, CRA training, IRB approvals, investigational product shipments, enrollment tracking, and recruitment planning
- Oversee clinical monitoring, site issue resolution, data queries, SAE reconciliation, and study conduct matters
- Manage or oversee close-out activities and timely TMF archiving
- Mentor Clinical Trial Associates assigned to clinical trials
आवश्यकताएँ
- Bachelor's degree in biology, allied health, nursing, or a related life science; an advanced degree is preferred
- At least three years of relevant clinical study execution experience
- Detailed understanding of clinical drug development processes
- Experience applying GCP, ICH, and FDA requirements
- Strong knowledge of clinical research processes and regulatory standards
- Understanding of human anatomy, subject protection, regulatory requirements, study design, and study execution
- Proficiency in study management, project planning, trial execution, timeline and milestone tracking, risk identification, and data review
- Strong written and verbal communication skills
- Ability to prepare summaries, correspondence, presentations, reports, and training materials
- Proficiency with word processing, spreadsheet, and database software, including Microsoft Word and Excel
- Strong attention to detail and accuracy
- Comfort working in a standard office environment and commuting daily to the assigned office
- Willingness to travel for business approximately 25%
लाभ
- Competitive pay and benefits through the employer's Total Rewards package
- Business travel opportunities of approximately 25%