8 Study Protocols Jobs

Role Overview: You will be responsible for collecting and entering clinical trial data from various sources, ensuring that it complies with study protocols and regulatory standards. Additionally, you will review the data for discrepancies, missing values, and inconsistencies, perform data cleaning, and uphold data quality standards. You will also be tasked with identifying, escalating, and resolving data queries in collaboration with clinical teams and study sites. Key Responsibilities: - Collect and enter clinical trial data from various sources - Ensure data complies with study protocols and regulatory standards - Review data for discrepancies, missing values, and inconsistencies - Perform...

As a Deputy Manager at Syngene International Ltd., your main responsibility will be handling QMS documentations like CC, CAPA, and Investigations, as well as managing EDMS documents, study protocols, and qualification protocols. You will be in charge of performing activities related to Engineering & maintenance at Biologics Unit 03 while ensuring GMP compliance and error-free operations. It will be crucial for you to follow all EHS requirements at the workplace to ensure individual and plant safety. - Complete all assigned mandatory trainings related to data integrity, health, and safety measures on time - Ensure compliance to quality systems and current good manufacturing practices - Develo...

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...

As an Associate Statistician at our organization, your role will involve assisting in conducting statistical analysis for clinical trials. You will be responsible for performing data cleaning and validation, as well as generating summary tables, figures, and listings. Additionally, you will collaborate with cross-functional teams to ensure data quality and integrity, contribute to the interpretation of study results, and stay updated with relevant regulations and industry best practices. Your qualifications should include a Bachelor's degree in Statistics, Biostatistics, or a related field. You will have the opportunity to work under the guidance of senior statisticians, conduct statistical ...

Role Overview: We are seeking a Study Director with proven experience in Safety Pharmacology to lead end-to-end studies in compliance with GLP and regulatory guidelines. The candidate should have prior CRO experience and be fully capable of independently designing study protocols, executing studies, and delivering comprehensive reports to clients. Key Responsibilities: Protocol Design: Develop scientifically sound and regulatory-compliant protocols for CNS, CVS, respiratory safety pharmacology studies, and hERG assay. Study Conduct: Oversee and ensure accurate execution of studies, coordinating with technical staff and laboratory teams. Data Analysis & Interpretation: Review raw data, perfor...

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...

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...

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. R...