The Data Management Project Manager is responsible for developing and implementing project plans for outsourced studies, ensuring that the activities are completed by vendors according to specified quality standards and timelines, and for coordinating ongoing data management activities with vendors to support the flawless execution of a clinical trial, by acting as the primary Data Management (DM) representative to the study management team. The DMPM ensures projects are appropriately resourced and proposes solutions for data management issues that arise during the course of a study.
Minimum of 5 years in the Data Management field, previous work with CROs and Data Management vendors is required, working in a global/cross-cultural setting is preferred
In-depth knowledge and understanding of the drug development process and data management process. Aware of related Pharma Industry SOPs, guidelines and Best Practices
Knowledge of GCP and other regulations. Aware of current global regulatory guidelines relevant to Clinical Data Management.
Technical/Software Skills: Familiarity with Oracle Clinical or other clinical data management system software; General software skills: Lotus Notes, MS Access, MS Word, MS Excel, MS Project
Strong understanding of database programming concepts.
Excellent multi-level, oral and written communication skills and presentation skills.
Ability to manage multiple programs and processes simultaneously.
Proven ability to build relationships and manage expectations with CROs and key Data Management service providers who represent single or multiple functions.
Internal customer management, influence of peers, team effectiveness and enhancement, timeline management, proactive problem solving ability, resource planning, ability to develop trust, shared goals and values.
Exhibits collaborative, conceptual thinking, systems process thinking, accountability to deliverables milestones, conflict resolution (internal and external).
Demonstrates leadership, negotiation and problem-solving
The candidate should be detail oriented, identify issues and assist in problem solving in a timely manner.
Education College Degree