Posted:
9/24/2024, 2:46:30 AM
Location(s):
Macedonia and Thrace, Greece ⋅ Municipal Unit of Psychiko, Attica, Greece ⋅ Pylaia Municipal Unit, Macedonia and Thrace, Greece ⋅ Attica, Greece
Experience Level(s):
Senior
Field(s):
Data & Analytics
Workplace Type:
Remote
As part of the Clinical Data Sciences (CDS) group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Data Manager is responsible for timely and high quality data review and query management of clinical data supporting the Pfizer portfolio. The 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, 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.
QUALIFICATIONS
Bachelor's degree in relevant field.
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 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.
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.).
Experience of project management skills in terms of resource management and timeline and quality control preferred.
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
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
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!
Website: https://www.pfizer.com/
Headquarter Location: New York, New York, United States
Employee Count: 10001+
Year Founded: 1849
IPO Status: Public
Last Funding Type: Post-IPO Debt
Industries: Biotechnology ⋅ Health Care ⋅ Medical ⋅ Pharmaceutical ⋅ Precision Medicine