Εκδήλωση ενδιαφέροντος
Τίτλος Αγγελίας:
1.2.2.3 Διευθυντές έρευνας και ανάπτυξης
Όνομα Εταιρίας:
PFIZER HELLAS ΑΕ
Αριθμός Δημοσίευσης:
18518
Ημερομηνία Δημοσίευσης:
27/11/2025
Είδος Εργασίας:
hybrid
Σύνοψη:
Snr Manager, Asset Lead, Clinical Data and Information Sciences Ath/Th
Εμπειρία:
Mid-level: with 5-10 years of experience
Παροχές:
Private health & life insurance, pension plan, annual bonus, meal allowance, stock options, etc
PFIZER HELLAS ΑΕ
1.2.2.3 Διευθυντές έρευνας και ανάπτυξης
Περιγραφή
Senior Manager, Asset Lead, Clinical Data & Information (Athens or Thessaloniki)
As part of the Clinical Data & Information Sciences (CDIS) 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 may 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 diligence.
Act 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 reporting.
Ensure 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 oversee the design, documentation, testing and implementation of clinical data collection tools, both CRF and non-CRFs using 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 customized 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.
Ειδικές Δεξιότητες
QUALIFICATIONS
Bachelor’s degree required. Degree in scientific field preferred. Master’s degree preferred.
Minimum 8 years Data Management experience required including 3+ years team leadership
Demonstrated successful experience in all relevant clinical data management activities in a Biopharmaceutical or CRO setting
Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review
Proficient experience using commercial clinical data management systems and/or EDC products (e.g. Medidata RAVE, Oracle RDC / Inform, etc)
Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) and data visualization tools (e.g. Spotfire)
Familiarity with MedDRA/WHO-Drug coding
Knowledge of risk-based monitoring principles & associated analytics/metrics
Proven experience in vendor oversight to meet aggressive timelines of high-quality data deliverables
Strong Project and Risk Management
Strong verbal and written communication in English skills; independently and effectively in multi-study, multi-disciplinary atmosphere in a matrix environment
Στοιχεία επικοινωνίας
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