Objectives and Scope of Position:
- Coordinates business projects within PDMA department
- Proactively collaborates with Global Product Development Medical Affairs Functions throughout the business project
- Collects and analyses project management data and information
- Communicates across functions and departments regarding PDMA projects
Summary of Main Responsibilities
- Cross-functional process review meetings
- Manages Global business process email account
- Organises and leads Team meetings with PDMA representatives
- Acts as one of the main contact persons for inter-departmental communication and communication with external business partners
- Provides feedback to Pharma Affiliates
Documentation and data management
- Collects, reviews and distributes business process documentation and data according to the timelines
- Ensures accurate tracking of key process tools, documents (CSRs, protocols etc.) and data
- Runs, updates trial list outputs and ensures the quality is according to the required standards
- Ensures business process systems (CTMS, AIMS) kept up to date and manages system support requests
- Archives Clinical files and documents in the appropriate filing area
Business Process Overview
- Planning business process implementation phases and execution according to the timelines
- Builds relationship with key internal and external business process stakeholders to ensure PDMA needs and goals are met
- Coordinates regular business project activities( trial lists updates, keeps process trackers up to date, monitors and analyses data deliverables)
- Ensures adherance of high level deliverables according to the timelines
- Guides, coaches and supports junior team members if needed
- Is responsible for acting in line with legal, regulatory and company standards and codes of practice
- Completes all required training modules as a priority
Successful candidates will demonstrate
A collaborative, supportive and engaging approach with people.
A forwards-looking, agile, and action-oriented approach to work.
Strong communication and organizational skills.
You will bring 5 or more years of experience in Biometrics, Operations, Clinical Science or Regulatory functions, within the Pharma industry, with knowledge of:
Clinical trial documentation such as Protocols and Clinical Study Reports.
Clinical trial management systems and trial-level data.
Clinical trial databases and patient-level data.
A Bachelors / Masters level Scientific degree.
Minimum 5 years of experience, working within the Healthcare / Pharma environment.