To independently perform and coordinate clinical data management activities for assigned clinical studies, ensuring accurate, complete, consistent, and GCP/regulatory‑compliant clinical trial data.
Responsibilities
Accountable for executing assigned clinical data management activities in accordance with study requirements, timelines, SOPs, and regulatory guidelines.
Accountable for performing data review, validation, and cleaning activities to ensure data accuracy, completeness, and consistency.
Accountable for raising, tracking, and facilitating timely resolution of data queries with investigative sites and internal stakeholders.
Accountable for monitoring CRF/eCRF completion, query status, and data discrepancies to support study milestones.
Accountable for supporting CRF/eCRF review, database testing, and User Acceptance Testing (UAT) activities as assigned.
Requirements
Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, Health Sciences, or a related discipline.
Responsible for providing data management services for clinical trials, ensuring on‑time and accurate deliverables, and supporting global clients across time zones.
Responsibilities
Provide data management guidance to internal project team members and customers
Communicate with internal project team members and customers on all aspects of data management activities
Author data management documents
Perform user acceptance testing on data management deliverables
Facilitate and verify data clarifications and data changes
Requirements
BA/BS degree in a relevant field (Medicine, Statistics, Computer Science) or equivalent work experience
The Associate Director, Medical Affairs will serve as a liaison to the medical/scientific community, responsible for establishing, developing, and maintaining relationships with prominent experts in pediatric neurology and epilepsy within the West Coast territory.
Internship program providing learning experience, mentoring and work experience in clinical trials, supporting regulatory, finance and supply functions.
Responsibilities
Prepare, collate, distribute and archive clinical documents
Support clinical supply and non-clinical supply management
Maintain tracking and reporting tools
Update clinical trial databases (CTMS) and trackers
Coordinate labeling requirements and translation change requests
Requirements
B.A./B.S. (Life Science preferred) or equivalent healthcare experience
Salary range is $170k to $235k and based on experience
Responsibilities
Build, maintain, and manage professional relationships with Key External Experts (KEEs) to organize networks at state levels.
Ensure the appropriate dissemination of clinical and scientific information regarding marketed and pipeline compounds in a timely, ethical and health care provider (HCP)-focused manner.
Implement clinical and educational strategies in collaboration with other company colleagues for designated HCPs/KEEs.
Organize medical and scientific training sessions, conferences and symposiums in medical centers and during scientific congresses.
Contribute to an efficient organization of medical communication activities for the marketed drug.