Senior Associate, Senior Data Manager, Clinical Data Sciences

Posted 23 Days Ago
Be an Early Applicant
Buenos Aires, Ciudad Autónoma de Buenos Aires, ARG
In-Office
Senior level
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
We’re in relentless pursuit of breakthroughs that change patients’ lives.
The Role
Lead data management for clinical trials: design and test databases/EDC, maintain Data Management Plan, manage queries and data review, coach junior DMs, report DM metrics, ensure submission readiness and SOP compliance, and drive continuous improvement.
Summary Generated by Built In
Application Instructions: Please submit your resume in English when applying.
Work 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.
Use Your Power for Purpose
Our mission is straightforward: support healthcare decisions that ensure the safe and effective use of medications. Whether you are developing the framework to ensure our evidence is scientifically robust, providing unbiased and medically essential expertise, or exploring ways to bridge data gaps, your role is vital. By ensuring our evidence is sound and offering necessary medical insights, we strive to improve patient care and treatment efficacy.
What You Will Achieve
In this role, you will:
  • Serve as Lead Data Manager for one or more clinical trials assuming responsibility for CDS activities including selection and application of data acquisition standards, database design (including specification documentation and testing of clinical data collection tools, both CRF and non-CRF, using an EDC system and/or other data collection systems), development and maintenance of the Data Management Plan, data review and query management, data access and visualization, Data Management metrics reporting, database release, and submission related activities.
  • Independently lead the daily DM activities and allocate study DM resource in the appropriate way.
  • Coach junior Data Managers in the study and perform peer review of study DM's deliverables for quality control.
  • Be responsible to achieve the study DM milestone on time with good quality.
  • In collaboration with the Clinical Data Scientist, ensure operational excellence across all CDS deliverables.
  • Ensure work carried out in accordance with applicable SOPs and working practices.
  • Ensure the required study-specific CDS documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously to support downstream inspection and submission readiness activities.
  • Ensure operational excellence in collaboration with 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.
  • Ensure lessons learnt during the course of the study are documented and shared with other study teams to facilitate cross study learning.
  • Be capable to contribute on the DM related continuous improvement activities

Here Is What You Need (Minimum Requirements)
  • Demonstrated knowledge of clinical development process including knowledge and understanding of the principles of GCP
  • Demonstrated knowledge of data management processes and principles in area of responsibility.
  • Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review
  • Demonstrates strong verbal and written communication skills including ability to communicate remotely
  • Minimum 3 years Data Management experience required
  • Working 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. , Inform preferred)
  • Experience using data visualization tools (e.g. Spotfire, J-Review) preferred
  • Familiarity with MedDRA/WHO-Drug
  • Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
  • Bachelor's degree minimum requirement.
  • Experience of project management skill in terms of resource management and timeline and quality control preferred.

Bonus Points If You Have (Preferred Requirements)
  • 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
  • Strong analytical and problem-solving skills
  • Ability to work collaboratively in a team environment
  • Excellent organizational and time management skills
  • Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

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.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Medical

Skills Required

  • Knowledge of clinical development process including GCP
  • Knowledge of data management processes and principles
  • Working knowledge of all phases of clinical trials and protocol review
  • Strong verbal and written communication skills including remote communication
  • Minimum 3 years Data Management experience
  • Working knowledge of clinical research regulations (FDA, ICH, GCP, GCDMP)
  • Proficient experience using commercial clinical data management systems and/or EDC (e.g., Inform)
  • Experience using data visualization tools (e.g., Spotfire, J-Review)
  • Familiarity with MedDRA and WHO-Drug coding
  • Proficiency with Microsoft Office Suite (Outlook, Word, Excel)
  • Bachelor's degree
  • Project management skills (resource management, timelines, quality control)
  • Master's degree
  • Relevant pharmaceutical industry experience
  • Awareness of regulatory requirements and relevant data standards
  • Strong analytical and problem-solving skills
  • Ability to work collaboratively in a team environment
  • Excellent organizational and time management skills
  • Experience using AI tools (e.g., ChatGPT, Microsoft Copilot) responsibly

What the Team is Saying

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Pfizer

Pfizer Compensation & Benefits Highlights

  • Healthcare Strength Multiple U.S. medical plan options include telehealth, comprehensive mental‑health support, fertility/family‑building benefits, transgender‑inclusive coverage, and certain Pfizer medications at no cost. A Wellbeing Wallet and wellness resources broaden the health and wellbeing offering.
  • Retirement Support A 401(k) with company matching is paired with an additional Pfizer Retirement Savings Contribution, alongside company‑paid life and disability insurance. One‑on‑one financial planning support is provided through Fidelity.
  • Leave & Time Off Breadth Paid time off spans vacation, holidays, and personal days, with additional caregiver and medical leave. U.S. parental leave commonly includes 12 weeks paid with options for additional unpaid bonding time and a return‑to‑work transition.

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The Company
HQ: New York, NY
121,990 Employees
Year Founded: 1848

What We Do

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.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.

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Pfizer Offices

Hybrid Workspace

Employees engage in a combination of remote and on-site work.

Typical time on-site: 2.5 days a week
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