3 Study Protocols Jobs

The PV Scientist Manager is responsible for contributing to the planning, preparation, writing, and review of non-medical portions of aggregate reports. Collaborating with affiliates and other internal Amgen partners, the PV Scientist Manager ensures timely deliverables. Additionally, reviewing Adverse Events/Serious Adverse Events from clinical trials is part of the role. Under the guidance of the Global PV Sr. Scientist or Lead, the PV Scientist Manager reviews study protocols, statistical analysis plans, and other clinical study-related documents. They provide input on the design of safety data tables, figures, and listings from clinical studies. Participation in the development of safety-related data collection forms, attending study team meetings, and conducting signal detection, evaluation, and management are key responsibilities. The PV Scientist Manager performs data analysis to evaluate safety signals, collaborates with the Global Safety Organization (GSO) on analysis results, and prepares safety assessment reports and other safety documents. They search and review adverse event data and relevant literature for signal detection purposes, participate in Safety Governance processes, and prepare presentations on safety recommendations for decision-making bodies. Assisting in the development of risk management strategies, providing content for risk management plans, updating regional risk management plans, overseeing risk minimization activities, and preparing responses to regulatory inquiries related to risk management plans are critical tasks. Supporting activities related to new drug applications and regulatory filings, contributing to safety-related regulatory strategies, and assisting in developing safety-related regulatory activities are also part of the role. In terms of Inspection Readiness, the PV Scientist Manager undertakes activities as delegated by the QPPV, maintains a state of inspection readiness, and acts as a representative and point of contact for Health Authority Inspections and Internal Process Audits within their role and responsibilities. Contributing to the Global Patient Safety (GPS) team, the PV Scientist Manager assists in developing, improving, and standardizing pharmacovigilance processes and methods. They also participate in teams for implementing new processes and methods within the Therapeutic Area. Basic Qualifications and Experience: - Masters or Bachelor's degree in a relevant field - Minimum of 9+ years of experience The PV Scientist Manager's role encompasses a wide range of responsibilities in pharmacovigilance, risk management, regulatory activities, and inspection readiness, contributing significantly to the safety and effectiveness of pharmaceutical products.,

The Clinical Trial Physician is responsible for providing medical input within the organization as well as to external partners and performing medical review tasks within the context of clinical trials. Furthermore, the Clinical Trial Physician is responsible for undertaking scientific/medical writing tasks within the organization. Role & responsibilities Is responsible for the development of: All study related documents that fall under the Clinical Science Department scope (e.g., Study Protocols, ICFs - in collaboration with other departments e.g., Clinical Operations, Regulatory, as required -, Pharmacy Manuals, Medical Review Plans, etc.), Scientific presentations and manuscripts, Medical training material (i.e. therapeutic area and study protocol training material) Delivers internal and external study protocol and therapeutic area training courses Provides medical expertise and consultation within the Company on key therapeutic areas of the clinical development program Provides guidance to all involved departments on the medical and scientific aspects of the assigned clinical trials/projects. Responds to medical queries from all involved parties in assigned clinical trials (e.g., CRAs, Project Managers, Clinical Operations Managers, Investigators) and collaborates with all concerned staff in maintaining an up-to-date study-specific Q&A log Is available 24/7 to respond to urgent medical/protocol related issues derived from an Investigational Site, as applicable Performs periodic medical review of the data from clinical trials according to the study-specific Medical Review Plan requirements (e.g., review of eligibility, review of efficacy and safety data). Performs real-time medical review on urgent medical and safety issues, as needed Collaborates with and provides medical input to the Data Management staff to ensure the successful development of the study-specific eCRF Attends Investigator Meetings and Conferences, as applicable Complies with the Company's Quality and Information Security Management Systems and applicable national and international legislation, including legislation for data protection and ICH GCP requirements Preferred candidate profile Required Medical Degree (MBBS, MD) Preferred: Clinical experience in the therapeutic area of the assigned study or of the Companys clinical development program - Preferred: 2 years of experience in a CRO or in the pharma industry in a relevant role (Clinical, Medical Information, Medical Affairs or PV) Key competencies Exceptional written and oral use of English In-depth knowledge of medical and drug terminology Good medical judgement and ability to make medical decisions Excellent communication skills Excellent business acumen Initiative taking and team working attitude Excellent Organizational skills Innovative thinking Excellent IT skills Deep understanding of the Clinical Development industry

Company Name: Exemed Pharmaceuticals ( Formulation Business) Designation: Sr. CT QA-Auditor Experience Range: 4-5 years Required Qualification: B. Pharm or M. Pharm (Pharmacology) or Msc in Clinical Research Name of Replacer, Please Specify: New Position Required Skill Set: 1. Must have experience of CT Phase 3 & Phase 4 Audits 2. Ready for travelling 3. Familiar with ICH-GCP guidelines 4. Proficient with MS excel, MS word and Power point 5. Experience with oncology trials is an additional advantage Job Description (Compulsory): 1. Prepare audit agenda, checklist and reports 2. Conduct and oversee audits of investigators site, vendors facilities and systems 3. Review of Site Master File 4. Review trial related documents such Study Protocols, CRFs, ICDs and Patient diary, Investigators Brochures and Patient diaries 5. Participate in regulatory inspections 6. Prepare various reports, intimation letters and arrange meetings as required 7. Communicate identified risks to reporting manager.