Asset Lead, Clinical Data Sciences

Asset Lead, Clinical Data Sciences

Location: Assignment: Buenos Aires, Argentina (Complejo LUMINA – Office Park). This role follows a hybrid model. Colleagues are expected to work from the assigned Pfizer office 2–3 days per week, or as required by business needs.

You will bridge evidence-based medical decision support with colleagues and stakeholders to enhance health and treatment outcomes. Whether developing frameworks to ensure our evidence is scientifically robust, providing unbiased and medically essential expertise, or investigating ways to close data gaps, your work will be pivotal in ensuring that accurate, timely, and consistent data reaches clinical teams and other groups. Your dedication will help Pfizer achieve new milestones and assist patients worldwide.

What You Will Achieve

ROLE SUMMARY

As part of the Clinical Data Sciences (CDS) group, an integral delivery unit within the Clinical Development & Operations (CD&O) organization, the Asset Lead is responsible for timely and high quality data management deliverables supporting the Pfizer portfolio. Responsibilities include delivery of asset level information strategies and services for optimal use and reuse of internal and external information that will advance research, development, and commercialization of the Pfizer portfolio and further precision medicine. The Asset Lead is expected to manage large or several smaller assets and may directly or indirectly design, develop, and maintain key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data, oversees application of standards, data review and query management, and is accountable for quality study data set release and consistency in asset/submission data. The Asset Lead have direct reports.

ROLE RESPONSIBILITIES

• As needed, serve as Clinical Data Scientist & Trial Lead for one or more clinical trials assuming responsibility for all CDS activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligence
• Act as the key scientific and technical data management expert; may define and drive the data management strategy and standards for the Therapeutic Areas (TA) as well as RBM standards, tools, data provisioning, and reporting
• Ensure work carried out by or on behalf of CDS is in accordance with applicable SOP’s and working practices.
• Serve as Subject Matter Expert (SME) for and oversees the design, documentation, testing and implementation of clinical data collection tools, both CRF and non-CRFs using and electronic data capture (EDC) system and/or other data collection systems.
• Data Integrity planning and ongoing monitoring of conformance of data quality to plan over multiple assets, through the implementation of customize central data monitoring strategies using appropriate tools and analytics.
• Key data management contact for regulatory inspections/audits in liaison with the appropriate Quality and Safety groups with Pfizer.

Here Is What You Need

• Demonstrated successful experience in all relevant clinical data management activities in a Biopharmaceutical or CRO setting
• Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review
• Strong Project and Risk Management
• Minimum 8 years Data Management experience required including 3+ years team leadership
• Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
• Proficient experience using commercial clinical data management systems and/or EDC products (e.g. Medidata RAVE, Oracle RDC / Inform, etc)
• Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) and data visualization tools (e.g. Spotfire, review)
• Familiarity with Med DRA/WHO-Drug coding
• Knowledge of risk-based monitoring principles and associated analytics/metrics
• Proven experience in vendor oversight to meet aggressive timelines of high quality data deliverables
• Strong verbal and written communication skills; independently and effectively in multi-study, multi-disciplinary atmosphere in an matrix environment
• Bachelor’s degree required. Degree in scientific field preferred. Master’s degree preferred.

EEO (Equal Employment Opportunity) & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.

Medical

Breakthroughs that change patients’ lives

Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.

Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:

“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.

“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.

“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.

Our Values

To fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.

Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.

Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.

Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.

Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.