Danielle Adams-Chell Email & Phone Number

Trenton, Nj, Us

Princeton, Nj

• Coordinates and authors documents needed for regulatory submissions (e.g., Phase 1/2 Clinical Study Reports, briefing documents, CTD summary documents, responses to Health Authorities, Investigator Brochures), ensuring the coordination and integration of the scientific, medical, and regulatory input from development members.• Participates in relevant document sub team(s) and ensures effective planning and management of timelines for all components of assigned documents.• Complies with internal and external processes and guidelines while managing the review process, resolves issues, errors, or inconsistencies on an ongoing basis, with pertinent team members to ensure timely completion and high quality of assigned documents.• Reviews and edits documents as required.• As required, coordinates writing of responses to Health Authority questions.• Analyzes and interprets clinical data from a broad range of therapeutic areas.

Princeton, Nj

• Drives the successful and timely execution of a clinical protocol from study startup to final clinical study report within established budget and timelines using strong protocol project management and organizational skills• Serves as primary operational contact for the protocol and coordinates the development of protocol level documents and plans • Leads a global team of individuals effectively that are assigned to the protocol and coordinates interaction among groups involved in the data collection, review, and analysis of the assigned study (or studies)• Collaborates with data manager, statistician and regional monitor project liaison to develop the case report form, data management plan, monitoring plan or other data review documents in accordance with applicable project standards • Monitors the progress of the study (or studies) and addresses and manages obstacles and interacts with senior members of the clinical team for resolution of more complex issues• Establishes and maintains effective communication with Investigators/staff and regional monitors; answers routine study related questions independently and documents substantive contacts concisely and in accordance with standard operating procedures• Assists in the preparation of Investigators Brochure, Annual Report updates, and clinical study reports • Promotes teamwork within and across departments; understands impact of issues noted in one study to the overall project; shares experiences and best practices• Demonstrates computer literacy and is able to function independently within an environment that relies heavily on technology for information and communication

Princeton, Nj