Works collaboratively with manager, peers and/or other team members to identify, recommend, and where appropriate/approved, implement new, creative, innovative learning & development offerings, techniques or others
Develop document management SOPs and Work Instructions for Clinical Operations and other functional areas with GCP responsibilities. Develop and implement paper document quality control scanning and destruction processes for TMF documents
Work with Global Medical Affairs teams to define the supply strategy for IP to support Investigator Initiated Trials (IITs) and collaborative studies in line with the study protocols. Work with Clinical Operations teams to define the supply strategy for clinical study IP in line with the study protocols
Conduct formal and informal presentations and convey complex scientific, reimbursement, and business information fluently to community and institutional based customers. Proficient with, and appropriate utilization of sales operations systems
Prepare and submit all the required submissions to FDA in support of clinical trials and marketing applications. Review and approve all documents used in regulatory submissions (including protocols and reports). Ensure the project team objectives and timelines are supported by regulatory deliverables.
Design risk based approach for validating and maintaining a variety of computer systems most of which are hosted and maintained by service providers. Fill the role of change coordinator during change management activities.
Identify, communicate, and escalate GCP corporate risk and serious non-compliance situations and follow to resolution, acting at all times with an appropriate sense of urgency. Monitor and reinforce timely completion of corrective and preventive actions that are defined to address GCP issues, regardless of the source.
Ensure/verify that collaborators (institutions, tissue banks) have appropriate documentation, process and procedures in place to ensure samples are collected according to ethical and legal standards (both prospective or retrospective sampling).
Responsible for the operational aspects of development and delivery of study protocols, informed consents, study plans, quality initiatives, etc. needed to conduct clinical trials while taking into account country specific requirements.