Job Overview
We are seeking an experienced Senior Clinical Data Manager to lead studies and take responsibility for the development of project documentation, system set-up, data entry and data validation procedures and processes assigned to more junior staff. The successful candidate will have a proven track record of delivering high-quality results, providing instruction to junior team members, and reviewing their output to ensure the highest quality.
Main Responsibilities:
* Assume responsibility for all DM activities (from study start-up to database lock) according to client quality expectations, within project timelines and budgets.
* Act as subject matter expert (SME) for DM activities in relationship meetings with Sponsors.
* Work directly with Sponsors to understand their direct requirements and lead implementation of those requirements.
* Regularly review client-specific processes to ensure they remain optimal for Sponsor and Pharmiweb.
* Mentor junior staff and provide guidance on DM practices.
Requirements:
* 8 years of combined early or late-stage DM experience with minimum 2 years of direct sponsor management and at least 2 years technical mentoring experience.
* Proven experience in handling customer negotiations and managing Scope of Work and budgets.
* Thorough knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations.
* Ability to work in a team environment and collaborate with peers.