34 Protocol Designing Jobs - Page 2

Requirement An advanced degree, including Ph.D., M.D., or PharmD/Masters degree with relevant experience in an appropriate discipline (e.g., economics, epidemiology, health administration, health services, medicine, pharmacoeconomics, psychology, statistics, or other relevant sciences) will generally be required, although significant previous training and experience in designing and conducting research and disseminating the results in the areas of health economics, health outcomes, disease management, and/or population health may substitute for the formal degree requirement. Strong comprehension and communication skills including the ability to translate and disseminate complex scientific in...

Ensure all aspects of department shipments to and from sites locally and internationally comply with applicable regulations, courier specifications and study parameters. Resolve shipping problems related to customs, FDA, dangerous goods or couriers. Ensure on-line shipping program is maintained within laboratory policy and procedural guidelines and users are trained. Assist with strategic initiatives at a local level. Essential Functions Assist with executing identified global initiatives at a local level within timelines Liaise with internal / external clients in relation to shipping regulations and logistics initiatives Advise Project Management on correct shipping materials and documentat...

Role & responsibilities *Feasibility assessment/ new product evaluation *Literature review and BA/BE study designing *BE Study Monitoring *Preparation of documents for regulatory submission (i.e BENOC, Import license application etc.) *Establishment and maintenance of study documents *Document preparation for dossier submission (i.e clinical overview, non-clinical overview, summery tables etc.) *Review of BE study documents i.e protocol, reports, ICF etc. *Preparation/review of medical write up * Coordination for serious adverse event reporting and safety update to Regulatory agency Preferred candidate profile M.Pharm (Pharmacology) with 1-5 Yrs with relevant experience Interested candidates...

Job Overview Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice. Essential Functions Advise Project Management on correct shipping materials and documentation to order for global studies Coordinate any special arrangements with couriers Gather data from PM about kit contents, site lists, etc , during protocol design Prepare commercial invoices, letters of instruction, and letters to airport police, and oversee pre-printed air bills to supply to sites to ensure specimens will be shipped in compliance with each county s regulations and each courier s specifications Operate all courier systems to prepare package address labels, invoices and other associated documen...

Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice. Essential Functions Advise Project Management on correct shipping materials and documentation to order for global studies Coordinate any special arrangements with couriers Gather data from PM about kit contents, site lists, etc , during protocol design Prepare commercial invoices, letters of instruction, and letters to airport police, and oversee pre-printed air bills to supply to sites to ensure specimens will be shipped in compliance with each county s regulations and each courier s specifications Operate all courier systems to prepare package address labels, invoices and other associated documentation correc...

Job description Remote & Full-time Opportunity for professionals with direct experience of min 2 years in disclosures. Job Description Summary The Clinical Trials Disclosure Specialist II position is responsible for the overall coordination and development of multiple disclosures deliverables, including but not limited to compliant registry authoring and maintenance of information on public registries, document redaction, and/or plain language authoring, ensuring adherence to relevant industry guidelines and client styles and formatting in accordance with all agreed upon timelines. Job Description Essential Functions: Independently performs/coordinates all activities for registration, mainte...

Role & responsibilities *Feasibility assessment/ new product evaluation *Literature review and BA/BE study designing *BE Study Monitoring *Preparation of documents for regulatory submission (i.e BENOC, Import license application etc.) *Establishment and maintenance of study documents *Document preparation for dossier submission (i.e clinical overview, non-clinical overview, summery tables etc.) *Review of BE study documents i.e protocol, reports, ICF etc. *Preparation/review of medical write up *Coordination for serious adverse event reporting and safety update to Regulatory agency Preferred candidate profile M. Pharm (Pharmacology) with 2-6 Yrs of Relevant Experience Interested candidates c...

Job Title: Senior Biostatistician Location: Bengaluru, KA Link to Apply: https://e.lilly/3DZ4ljx Purpose: The Clinical Project Statistician develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, veterinarians, and/or medical colleagues. The Clinical Project Statistician is responsible for working with research associates and scientists to establish a reporting database and for analyzing data for these types of studies. Key Responsibilities: The job tasks listed below outline the scope of the position. The application of these tasks may vary, based upon current business needs. Statistical Trial Design and Analysis ...

Senior Medical Writer in Clinical Research @ Vimta Labs Ltd, Hyd Experience: 10-15 years in Medical writing field in Clinical Research BA/BE studies CTC : As per market standards Report to: Principal Investigator Clinical Primary Responsibilities: 1. Ensures that Good Clinical Practices (GCP) and NDCT (New Drugs and Clinical Trials Rules) are followed. 2. Writing and developing BA/BE and clinical trail protocols. 3. To perform literature search and preparation of feasibility. 4. Preparation of study specific informed consent forms (ICFs), case report forms (CRFs) and blood sample forms. 5. Preparation of clinical study reports (CSRs), DBE/summary tables, CS-BE tables and module 2.7.1 (M 2.7....