Senior Data Manager, Clinical Data Management

ROLE SUMMARY
As part of the Clinical Data & Information Sciences (CDIS) group, an integral delivery unit within the Clinical Development & Operations (CD&O) organization, the Senior Data Manager is responsible for timely and high quality data review and query management of clinical data supporting the Pfizer portfolio . The Senior Data Manager develops and maintains key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data.
ROLE 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 (CDS), ensure operational excellence across all deliverables.

• Ensure work carried out in accordance with applicable SOPs and w orking practices.

• Ensure the required study-specific CDIS 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.

QUALIFICATIONS

• Bachelor's degree minimum requirement.
• Minimum 3 years Data Management experience required.
• 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 clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements.
• Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review.
• Familiarity with MedDRA/WHO-Drug.
• Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.).
• Demonstrates strong verbal and written communication skills including ability to communicate remotely.
• 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.
• Experience of project management skill in terms of resource management and timeline and quality control preferred.

Work Location Assignment: Hybrid
Please apply by sending your CV and a motivational letter in English
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
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Equal Employment Opportunity
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Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
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