The Clinical Trial Manager is responsible for the day to day operation of a given clinical study. Responsibilities include:
The development of clinical protocols, Investigator’s Brochures, information/consent forms, training material, case report forms, diary cards, clinical study reports and other clinical documents, as required by the project.
Participation in writing clinical sections in regulatory documents (e.g., BLA or IND).
Manage internal Clinical Research Associates and provide guidance for their overall professional development.
Define project specifications, assisting with the evaluation of potential providers, and monitoring progress on an ongoing basis.
Manage study timelines. Reports on study progress and provides options for handling problems that develop. Appraises line managers of situations as they arise and provides progress updates/summaries as required.
Ensure that all tasks that contribute to the conduct of a clinical study are completed on time and within budget.
Provide input into protocols, case report forms, data management plans, clinical study reports, and regulatory filings.
Design and review informed consent forms and other study related documents in compliance with ICH CGP guidelines.
Maintain paper and electronic filing systems and tracking systems.
Requirements:
A BS and/or MS in life sciences or healthcare discipline with 3-5 years of hands-on clinical operations experience in the biotech/pharmaceutical industry is required.
Additional experience in site monitoring and overseeing CRA’s is required.
Knowledge of good clinical practice (GCP) and FDA and ICH regulations and guidelines.
Good understanding of cross functional areas including data management, medical writing, and biostatistics.