Senior Manager, Early Clinical Development, Clinical Pharmacology Studies
Core
Designing and providing clinical oversight for early clinical pharmacology studies to move promising compounds from concept into patients' hands.
Role type
Senior Manager, Early Clinical Development, Clinical Pharmacology Studies
Builds
Clinical study protocols, informed consent documents, clinical study reports, and regulatory submissions (INDs, IBs, DSURs)
Domain
Pharmaceutical / Clinical Pharmacology / Early Drug Development
Required skills
Clinical pharmacology study design, GCP/ICH compliance, medical writing, regulatory document authoring, data integrity management, site initiation training, clinical trend monitoring
Preferred skills
Experience in immunology, cardiovascular, haematology, or oncology therapeutic areas
Technologies
Microsoft Word, Excel, PowerPoint, data review tools
Responsibilities
Develop and refine protocols and ICF documents for governance committees; Collaborate with data management to design eCRFs and Data Review Plans; Author and review clinical study reports and regulatory submissions; Present at site initiation visits and investigator meetings; Monitor clinical trends to ensure participant safety
Seniority
Senior Manager, hands-on IC