8 Job openings found

• Deliver timely consistent, accurate and reproducible coding of clinical trial data using industry standardcoding dictionaries (MedDRA, WhoDrug) in line with global and therapeutic area guidelines.• In collaboration with Global Data Manager, develop trial coding specifications in line with trial requirementsdefining coding elements, dictionary versions and review timelines.• Complete and ...

Sub-Family DescriptionProvides medical, scientific, and therapeutic expertise on pharmacovigilance services.Participates in all aspects of the Medical Safety activities as per scope of work, such as performing medical reviewand clarification of trial-related Adverse Events including review of analysis of similar events, medical evaluation ofpost-marketing adverse drug reactions, review medical inputs for ...

Minimum Requirements:• Bachelor’s degree in statistics, biostatistics, mathematics, computer science or lifesciences required.• A programming experience in industry recommended.• For US positions: US military experience will be considered towards industryexperience.• Demonstrated proficiency in using SAS, R or other programming languages toproduce derived analysis datasets and TFLs.• Understanding of clinical data ...

Job Responsibilities: Site monitoring, source verification, query resolution & ensuring protocol compliance Visit investigator sites for initiation, monitoring & close-out activities Support eTMF, CTMS, EDC documentation and trial coordination Track patient recruitment, AE/SAE reporting, IP accountability, and site communications Required Qualification: B.Pharm / M.Pharm / MSc Clinical Research / Life Sciences 1–3 years CRA experience in CRO ...

Job Responsibilities: Maintain QMS documentation, SOPs, training records & audit readiness Conduct internal audits for clinical, BE & pharmacovigilance operations Support vendor audits, gap assessments, CAPA tracking, compliance reviews Ensure adherence to ICH GCP, regulatory guidelines & quality standards Required Qualification: B.Pharm/M.Pharm/MSc in Life Sciences 1–3 years experience in QA within CRO/BE/Clinical Trial setup Understanding of QMS, risk ...

  Review of CRF Design against Protocol and Sponsor Specifications (SSPs). · Audit of database against the CRF to ensure compliance to Protocol, Regulatory requirements, In-house SOPs and SSPs. · Conduct audit of Clinical Data Management, Biostat and Programming, Consumer Research, and Software Development activities and communicate audit observations to the respective department. ...

Their role combines administrative and clinical responsibilities to ensure the efficient and effective delivery of patient care. This role involves supervising and supporting clinical staff, optimizing workflow and resource allocation, and collaborating with other departments to achieve departmental and organizational goals. Responsibilities: Provide leadership, guidance, and direction to clinical staff, fostering a positive ...

Role: • Preparation and review of Electronic Common Technical Document (eCTD), PSUR. PADER or RMP in compliance with EU and US standards and protocols. • Write, edit clinical study protocols. clinical study reports, summary documents, investigator brochures, portions of regulatory briefing documents and development safety update reports. • Drafting and revising pre-clinical summaries. • ...