Senior Manager, Asset Lead, Clinical Data Sciences, Clinical Data Sciences (Buenos Aires)

Senior Manager, Asset Lead, Clinical Data Sciences, Clinical Data Sciences (Buenos Aires)

01 ago
|
Pfizer, S.A. De
|
Buenos Aires

01 ago

Pfizer, S.A. De

Buenos Aires

Senior Manager, Asset Lead, Clinical Data Sciences, Clinical Data Sciences
We're in relentless pursuit of breakthroughs that change patients' lives.
We innovate every day to make the world a healthier place.
To fully realize Pfizer's purpose – Breakthroughs that change patients' lives – 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.
Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.
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.
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 diligenceAct 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 reportingEnsure 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 settingWorking knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol reviewStrong Project and Risk ManagementMinimum 8 years Data Management experience required including 3+ yearsteam leadershipKnowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirementsProficient 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 codingKnowledge of risk-based monitoring principles and associated analytics/metricsProven experience in vendor oversight to meet aggressive timelines of high quality data deliverablesStrong verbal and written communication skills; independently and effectively in multi-study, multi-disciplinary atmosphere in an matrix environmentBachelor'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.
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 .
#J-*****-Ljbffr

📌 Senior Manager, Asset Lead, Clinical Data Sciences, Clinical Data Sciences (Buenos Aires)
🏢 Pfizer, S.A. De
📍 Buenos Aires

Postulate a este anuncio

Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.

Suscribete a esta alerta:

Recibe por email las nuevas ofertas de trabajo para: senior manager, asset lead, clinical data sciences, clinical data sciences (buenos aires) / buenos aires

Suscribete a esta alerta:

Recibe por email las nuevas ofertas de trabajo para: senior manager, asset lead, clinical data sciences, clinical data sciences (buenos aires) / buenos aires