Senior Clinical Data Scientist
Pfizer
full-time
Posted on:
Location Type: Hybrid
Location: Thessaloniki • Greece
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Job Level
About the role
- Serves as Clinical Data Scientist and Trial Lead for one or more clinical trials assuming responsibility for all CDIS activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligence.
- May functionally manage a team of Associate Data Managers, Senior Data Managers, be responsible for resource allocation, training and development.
- Works with Asset Leads to establish strategy, timelines, and adequate resourcing of DMs at Asset/Study level.
- Ensures appropriate documentation across the lifespan of the study/asset for all DM deliverables and ensures the required study specific CDIS documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously.
- May likely be involved in development of TA specific standards.
- Provides project management leadership to DM teams – Responsible for managing issues at the study level as they arise and proactively communicating to Asset Lead and Management while serving to provide solutions.
- Acts as the key scientific and technical data management expert; contribute to department level initiatives and ensure effective reporting of study status and metrics to Management.
- Ensures work carried out on behalf of CDIS is in accordance with applicable SOPs and working practices.
- Serves 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.
- May act as data management contact for regulatory inspections/audits in liaison with the appropriate Quality and Safety groups with Pfizer.
Requirements
- Bachelor’s degree required.
- Degree in scientific field preferred.
- Master’s degree preferred.
- Minimum 7 years Data Management experience required, including experience in 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.
- Strong Project and Risk Management.
- CRO and vendor oversight experience preferred.
- Strong verbal and written communication skills.
- Consistent, detail oriented, communicative, dedicated to do a job well done.
- Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements.
- Proficient experience using commercial clinical data management systems and/or EDC products (Medidata RAVE, Oracle RDC, Inform preferred).
- Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) and data visualization tools (e.g. Spotfire, jReview).
- Strong knowledge of MedDRA/WHO-Drug.
- Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.).
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Data ManagementClinical Data ManagementProject ManagementRisk ManagementData Acquisition StandardsClinical Trial PhasesRelational DatabasesData VisualizationMedDRAWHO-Drug
Soft Skills
Team LeadershipCommunicationDetail OrientedProblem SolvingTraining and DevelopmentResource AllocationProactive CommunicationDedicationOrganizational SkillsInterpersonal Skills