Provides technical knowledge and support of clinical trials applications, regulatory requirements for study start up and clinical trials application maintenance for both internal customers and external clients related to investigational drugs biologicals and medical devices.
Primary job responsibilities include the preparation and coordination of global regulatory submissions to support the initiation of clinical trials for investigational drugs. Supports business development efforts. May participate in project teams, leads specific regulatory tasks, and serves as regulatory lead on multiple projects. Manages internal resources and projects to completion.
Duties and Responsibilities (including but not limited to) vary with specific position:
* Training of applicable NA CSU staff on TMF procedures, systems and archiving expectations (paper and/or electronic) - in collaboration with Global Record Management Team.
* Responsible for the functional management of NA CSU Local Study File staff, indexing staff and other personnel as assigned.
* Develop KPIs to measure TMF quality and completeness and share metrics with key stakeholdersPerform and document regular quality control checks to ensure continual document filing as planned for clinical trials in the NACSU.
* Implement local filing processes and ensure adherence to quality documents (related to local study files) as needed and ensure local Canadian and US library reference is up to date in collaboration with Global record Management team.
* Ensure completion of applicable accession checklist on time for archiving deadlines (in collaboration with Global Record Management team timelines and Clinical Study Team), and documents are shipped to final archiving location.
* Alert and escalate filing deviations/risks accordingly to CSU Management.
* Facilitate audit and inspection (including Pre-Approval Inspection) activities.
Education and Work Experience:
* Must have a high level of understanding of information technology, and computer expertise (e.g., eTMF, demonstrated proficiency with MS Office applications, scanning, etc.)
* Clinical trial related experience with strong background in filing is a must. Possess strong organizational skills, training, coaching, and communication skills.
* Ability to understand and develop performance.
* Bachelor's degree (or equivalent).
* Must have 5 years of experience in a Pharmaceutical research environment.
* Preferred: Experience in Leading teams, project management
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.