Real World Evidence (RWE) generation is a critical strategy enterprise wide. Non-Interventional Study (NIS) and Low Interventional Study (LIS) RWD collection, evidence generation and outcomes & analytics are key to filling unmet data needs and informing medical strategy. The Medical Evidence Generation Study Assistant is part of the team for RWE studies, and is responsible for supporting the Study Manager (SM) for assigned studies to ensure compliance with ICH-GCP, SOPs, and regulatory regulations. The role collaborates directly with SM and as required with other team members and supports them in the efficient execution of clinical studies. The role is part of the Medical Evidence Generation Operations Team within Worldwide Medical and Safety (WMS) and is primarily responsible for operational planning and project management for Global Medical Epidemiology led studies (https://e.g., CT-24 GSOP and CT-34 GSOP) to ensure consistency and compliance in process adherence.
The major duties and responsibilities will include but are not limited to the following
Provides study level operational support to the Core Study Team from study start up to close out and submission with general direction:
- Management of Study Team shared spaces
- Support vendor management compliance under applicable SOPs in preparation for contract execution
- Non-interventional Study Master File (NISMF) maintenance and compliance
- Data entry on Study Management Platform
- Support and follow up on metrics under the surveillance of SM
- Study Management system(s) compliance and maintenance
- Tracking of study level information; follow up with functional lines as needed
- Liaising with cross functional study team members:
- Execute the completion of study level forms and data entry into various clinical operations applications and systems
- Quality Control (QC) of essential clinical study documents
- Provides logistical/operational support to Study Management for Investigator Meetings
- Provides status updates on key tasks and activities to the Study Manager and contribute to Team Meetings
- Works proactively to prioritize multiple study tasks in support of study systems and processes
- Uses established procedures and methodologies to ensure the completion of assigned tasks according to timelines and to required quality standards
- Supports short term Operational Special Project requests (https://e.g. workstreams, initiatives, projects)
- Manages own time to meet agreed targets; develops plans for short-term work activities on own projects (timelines, work plans, deliverables)
- (https://B.S or https://B.A) with 0 to 2 years’ experience
- Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research
- Science background
- Effective verbal and written English communication skills
- Ability to work independently but also as part of a larger team
- Ability to multitask and manage multiple competing priorities
- Self-motivated and ability to organize tasks to ensure timelines are met and deliverables are of high quality
- Basic Knowledge of drug development process
- Attention to detail evident in a disciplined approach to document review, adherence to SOPs, metrics, etc.
- Good problem solving & decision-making skills: Ability to work in ambiguous situations within the team Seek input from others when faced with a difficult situation; Make sound decisions within the scope of responsibility; Focus on resolving problem
- Administrative and technical capabilities are required.
- Knowledge of IT systems/software for database maintenance and document management.
- Proficient in Microsoft office applications (Outlook, Word, PowerPoint, Excel, TEAMS)
- Demonstrated effectiveness working in a multidisciplinary, matrix team situation, and demonstrated ability to manage change and diversity.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.