Clinical Research Coordinator independently managing key aspects of clinical trials. Overseeing data management and ensuring compliance with study protocols and regulations.
About the role
- Associate Clinical Research Director providing medical expertise to clinical studies and supporting development activities in a global biopharmaceutical company. Collaborating with stakeholders to ensure optimal study execution.
Responsibilities
- Provide medical expertise to the clinical studies (except select Exploratory Pharmacology studies) and/or registries (eg: protocol, Key Results, Clinical Study Report)
- Support other clinical development activities (e.g. pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment)
- Contribute to the Extended synopsis and Protocol for their project
- Contribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authorities
- Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators
- Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data
- Develop the abbreviated protocol
- Develop the final protocol and protocol amendments
- Medical support to clinical operation team during the clinical feasibility
- Review and provide clinical input across different study documents written subject information, CRF, e-diary, monitoring plan
- Medical support to clinical operations team on study plans: CMP/MRP, DR & DS review
- Review/approve study-related documents (eg vendor specifications for centralized services, CRF, CRF completion guidance, patient diary, etc)
- Participate in the elaboration of training material and presentations at the investigator meetings
- Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety, stat outputs of blinded data, …) with operational support, bio stat and GSO
- Answer to medical questions raised by EC/IRBs, sites
- Support CRD trial master file documents readiness and availability, and mandatory trainings linked to the clinical function
- Collaborate and communicate appropriately with all function stakeholders to ensure optimal study execution in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs), including but not limited to: ü feasibility managers for feasibility preparation and validation of feasibility results ü Medical Writers to develop, review and finalize WSIs, study protocols and reports ü Clinical Scientists, Medical review team and Coding ü Pharmacovigilance (GSO, CME) ü CTOMs, Biostatisticians ü CSU medical advisors for the best knowledge of the study, compound, protocol ü TA Experts, senior CRDS, global clinical lead, GPHs and medical affairs ü CROs ü Regulatory affairs
- Collaborates with other CRDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. He/she raises study or project-level issues to the global project head and clinical lead
- Provide operational expertise to project clinical sub team, as needed
Requirements
- Medical Doctor (MD) preferred: Pediatrician, Neurologist, Hematologist
- English fluent (spoken and written)
- At least 3 years in pharmaceutical industry or CRO, previous experience in clinical development
- Understanding of pharmaceutical product development and life cycle management gained through preferably ~3 year of development and / or medical / clinical experience
- Good Scientific and medical expertise
- Good knowledge / expertise in clinical development and methodology of clinical studies
- Fluency in written and spoken English
Benefits
- Copperate with strong, independent technology group and experience digital & innovative ways of working
- Be viewed as a trusted partner, shared goals and quality work
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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