Pfizer - Collegeville, PA
posted 2 days ago
Full-time - Mid Level
Collegeville, PA
Chemical Manufacturing
About the position
Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.
Responsibilities
- Manage own time to meet agreed targets; develop plans for work activities on own projects within a team.
- Serve as Data Manager for one or more clinical trials assuming responsibility for Data Monitoring and Management (DMM) activities.
- Ensure operational excellence in collaboration with partners and colleagues for application of standards and develop data cleaning reports in support of the data review plan.
- Ensure operational excellence across all Data Monitoring and Management (DMM) deliverables.
- Set-up and test data review listings to verify the quality and completeness of data as specified in Data Management Plan by reviewing data attributes populated by general users.
- Ensure lessons learnt during the study are documented and shared with other study teams to facilitate cross-study learning.
- Build good relationships with local and global SMEs from different fields, leverage their expertise in areas such as systems and process and proactively identify issues and work to create solutions.
Requirements
- Bachelor's Degree
- 3+ years' experience
- Demonstrated knowledge of data management processes and principles
- Experience with web based data management systems
- Working knowledge of electronic document management systems
- Knowledge of International Conference on Harmonization and more specifically Good Clinical Practices
- Thorough understanding of the processes associated with clinical study management and regulatory operations
- Ability to manage tasks, time and priorities
- Demonstrated effective verbal and written communication skills and adapt communications to audience.
Nice-to-haves
- Master's degree
- Relevant pharmaceutical industry experience
- Experience using data visualization tools
- Proficient experience using commercial clinical data management systems and/or EDC products
- Awareness of regulatory requirements and relevant data standards.
Benefits
- 401(k) plan with Pfizer Matching Contributions
- Paid vacation
- Paid holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental and vision coverage
