Malvern, PA, United States
Manager, Operations, Healthcare, Clinical Research, Pharmaceutical
This new role will be responsible for the execution, and reporting of all clinical trial activities, ensuring adherence to study timelines, budgets, Quality Plans and applicable FDA/ICH/NIH guidelines. The individual in this position will also be responsible for effective management of Clinical Contract Research Organization activities.
Writes and/or reviews protocols, protocol amendments, informed consent forms, annual reports and regulatory submission documents.
Participates in interim reporting requirements to DSMBs and NIH.
Participates in the development of outsourcing strategies, including the selection of CRO’s and other external vendors, and the development of clinical trial budgets.
Manages/monitors clinical study activities and execution by the CRO’s.
Participates in the development of EDC and IWRS specifications for the clinical studies
Accountable for ensuring that all studies are carried out according to the study protocol, SOPs, applicable GCP/ICH guidelines.
Identifies and resolves problems, conflicts and obstacles to the success of projects.
Participates in clinical operations process improvement initiatives to address clinical needs (e.g., development of investigator database, standardized CRF modules, etc).
B.S/B.A. degree in a science-related field
7 years of clinical research experience, including clinical trial execution and reporting
Must have experience in Phases 1-3 with international trial experience
Familiarity with data management, as well as electronic data capture tools and 21CFR11 requirements
Excellent knowledge of ICH/GCP guidelines
Strong medical/scientific writing skills
Experience authoring protocols and clinical sections of clinical documents