Why Patients Need You
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.
What You Will Achieve
It is our mission to strengthen the oversight of our clinical data through stronger ownership, control, and visibility. You will play an important role in processing, reviewing and receiving clinical data and records and from therapeutic groups as well as internal and outside investigators. You will ensure that accurate, timely, and consistent data reaches the clinical teams and other groups. You will be relied on for data management plans, including data preparation and validation activities, among others.
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As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing important deliverables on time. Your innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams.
It is your commitment and hard work that will help make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- Contributesto the development and assists with the implementation of the TMF specifications, such as process and system changes.
- Leadsthe set-up of the TMF Study Specific Document List (SSDL) and monitors completeness and quality of TMF content for all assigned clinical trials until study close out.
- Ensures documentation flow is within projected timelines and determines course of actionsto prevent and remediate timeline delays.
- Ensures consistent use of standardized processes and technologies across clinical trials and programs. • Serves as point of contact for internal and external audits ofstudy TMF-related queries.
- Actively identifies continuousimprovement opportunitiesto enhance operational efficienciesthrough process and metrics analysis.
- Providessupport and guidance to the study teamsto drive performance against metric targets.
- Applieslessonslearned to continuousimprovement of documentation management practices acrossstudy teams.
- Provides education, feedback and support to study teamsin order to build knowledge and awareness of good document management practices and TMF for clinical trials. • Ensuresthat the program documentation supportsthe regulatory package requirements.
Qualifications
Must-Have
- 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-Have
- 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
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
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