Senior Associate, Senior Data Manager, Clinical Data Sciences
Pfizer
Senior Associate, Senior Data Manager, Clinical Data Sciences
Job Description
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 PurposeOur 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 AchieveIn 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 activitiesHere Is What You Need (Minimum Requirements)Demonstrated knowledge of clinical development process including knowledge and understanding of the principles of GCPDemonstrated 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 reviewDemonstrates strong verbal and written communication skills including ability to communicate remotelyMinimum 3 years Data Management experience requiredWorking knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirementsProficient 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) preferredFamiliarity with MedDRA/WHO-DrugProficiency 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 degreeRelevant pharmaceutical industry experienceExperience using data visualization toolsProficient experience using commercial clinical data management systems and/or EDC productsAwareness of regulatory requirements and relevant data standardsStrong analytical and problem-solving skillsAbility to work collaboratively in a team environmentExcellent organizational and time management skillsExperience 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 useEEO (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
Locations
- Argentina - Buenos Aires
Skills Required
- clinical development process including knowledgeintermediate
- data management processesintermediate
- all phases of clinical trialsintermediate
- clinical researchintermediate
- data visualization toolsintermediate
- MedDRA/WHO-Drugintermediate
- use of Microsoft Office Suite of toolsintermediate
- common AI toolsintermediate
Required Qualifications
- Demonstrated knowledge of clinical development process including knowledge and understanding of the principles of GCP (experience)
- Demonstrated knowledge of data management processes and principles in area of responsibility. (experience)
- Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review (experience)
- Demonstrates strong verbal and written communication skills including ability to communicate remotely (experience)
- Minimum 3 years Data Management experience required (experience, 3 years)
- Working knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements (experience)
- Proficient experience using commercial clinical data management systems and/or EDC products (e.g. , Inform preferred) (experience)
- Experience using data visualization tools (e.g. Spotfire, J-Review) preferred (experience)
- Familiarity with MedDRA/WHO-Drug (experience)
- Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) (experience)
- Bachelor’s degree minimum requirement. (degree)
- Experience of project management skill in terms of resource management and timeline and quality control preferred. (experience)
- Demonstrated knowledge of clinical development process including knowledge and understanding of the principles of GCP (experience)
- Demonstrated knowledge of data management processes and principles in area of responsibility. (experience)
- Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review (experience)
- Demonstrates strong verbal and written communication skills including ability to communicate remotely (experience)
- Working knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements (experience)
- Proficient experience using commercial clinical data management systems and/or EDC products (e.g. , Inform preferred) (experience)
- Experience using data visualization tools (e.g. Spotfire, J-Review) preferred (experience)
- Familiarity with MedDRA/WHO-Drug (experience)
- Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) (experience)
- Experience of project management skill in terms of resource management and timeline and quality control preferred. (experience)
Preferred Qualifications
- Master's degree (degree)
- Relevant pharmaceutical industry experience (experience)
- Experience using data visualization tools (experience)
- Proficient experience using commercial clinical data management systems and/or EDC products (experience)
- Awareness of regulatory requirements and relevant data standards (experience)
- Strong analytical and problem-solving skills (experience)
- Ability to work collaboratively in a team environment (experience)
- Excellent organizational and time management skills (experience)
- 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 (experience)
- Relevant pharmaceutical industry experience (experience)
- Experience using data visualization tools (experience)
- Proficient experience using commercial clinical data management systems and/or EDC products (experience)
- Awareness of regulatory requirements and relevant data standards (experience)
- Strong analytical and problem-solving skills (experience)
- Ability to work collaboratively in a team environment (experience)
- Excellent organizational and time management skills (experience)
- 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 (experience)
Responsibilities
- 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
- 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
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