Description
* Participates in strategic discussions regarding the design of clinical programs and in reporting the progress of clinical programs by working collaboratively with the global Core Team and sub-teams.* Negotiates study timelines during project development and manage clinical operation activities to meet enrollment targets according to the projected timeline.
* Utilizes budget software to develop study budgets and manages studies within approved budget guidelines.
* Recommends and administers budgets, schedules and resource requirements for assigned projects.
* Responsible for development and implementation of study protocol(s) in accordance with Good Clinical Practices (GCPs) and current Standard Operating Procedures (SOP(s)).
* Manages clinical operations activities for assigned projects, including but not limited to, the following:
- Prepares/procures of all manner of documents and supplies related to the clinical trial process (e.g Investigator's Brochure, Protocols, Case Report Forms, Informed Consent Documents, etc.)
o Develops the clinical sections for submissions to regulatory bodies (e.g. FDA, EMA, etc.) and IRBs/ECs (e.g. INDs, NDAs, Annual Reports, Pre-meeting Packages, Clinical Study Reports, etc.) for assigned project(s).
o Manages Clinical Operations activities to evaluate and select sites, vendors (e.g. IXRS, lab, reading centers), consultants, CROs, etc. for assigned studies.
o Develops monitoring requirements to assure quality monitoring activities.
o Negotiates and prepares all legal and financial documents (e.g. contracts, budget proposals, confidentiality and indemnification agreements, insurance, etc.).
o Monitors clinical studies to assure they are conducted in compliance with the protocol, Standard Operating Procedures, Good Clinical Practice and appropriate regulatory requirements.
* Manages Clinical Operations activities working with Clinical Science, Biometrics, Drug Safety and other departments to coordinate the review, evaluation, quality, validation and reporting of moderate to complex clinical data.
* Prepares and/or presents written and oral presentations regarding clinical trial progress/results.
* Writes clinical standard operating procedures and provides training to more junior level clinical operations colleagues.
* Maintains up to date extensive knowledge and understanding of Good Clinical Practices, regulations and guidance documents and industry trends/best practices.
* Develops and maintains relationships with key opinion leaders (KOLs) and clinical scientists to support development activities on a global basis.
To find out more about Real please visit www.realstaffing.com