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.

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

• Participate in DMM activities including data review and query management, assist with quality database design including documentation, testing, validation, and implementation of clinical data collection tools, CRF and non-CRF, using an electronic data capture (EDC) system and/or other data collection systems, supporting the database set up activities as assigned by Senior Data Manager or Clinical Data Scientist.
• Ensure work carried out in accordance with applicable SOPs and working practices.
• Assist with the required study-specific DMM documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously to support downstream inspection and submission readiness activities.
• Assist with operational excellence in collaboration with other Data Manager’s and CDS for application of standards, data acquisition, proactive data review and query management, data cleaning, e-data processing, data access and visualization, DM metrics reporting, database release, and submission related activities

Qualifications

Must-Have

• Awareness of clinical development and pharmaceuticals as a regulated industry
• Awareness of healthcare regulatory authorities (e.g. FDA, Health Canada)
• Ability to learn clinical data management processes and principles in area of responsibility.
• Demonstrates required verbal and written communication skills including ability to communicate remotely
• Capable to learn technical data systems
• Capable to learn how to use data visualization tools (e.g. Spotfire,  J-Review)
• Awareness of MedDRA/WHO-Drug preferred
• Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
• Bachelor’s degree minimum requirement. Health Sciences experience or Technology degree preferred.
• At least 4 years of experience in Clinical Data Management, performing complete data review activities, in a CRO or a Pharma Company.

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.