Senior Clinical Data Manager Ii

Join our dynamic team as a Senior Clinical Data Manager II, where you will be responsible for coordinating the Clinical Data Management (CDM) deliverables on assigned clinical studies. You will act as a core member of the Global Study Team and lead studies with less complexities. This role is within our Biopharmaceuticals R&D department, where we are driven by our desire to understand and reveal new insights.
As a Senior Clinical Data Manager II, you will coordinate the Clinical Data Management deliverables on assigned studies, serve as the first line of contact at the study level, and demonstrate leadership in the planning and delivery of CDM deliverables. You will communicate and collaborate effectively with all study team members and oversee day-to-day operational aspects of CDM for assigned studies. You will also mentor junior Clinical Data Management colleagues and perform CDM related ad-hoc requests from Line Manager.
Essential Skills/Experience

University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree
Knowledge of Clinical Data Management and experience in the Biotech/Pharma/CRO industry
Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements
Demonstrated experience of clinical databases, different clinical data management systems and electronic data capture (EDC)
Demonstrate understanding and experience in query management process and reconciliation activities
Ability to work flexibly on simultaneous projects and proactively manage time to meet own deadlines.
Excellent written and verbal communication skills
Ability to work in a global team environment
Excellent organizational and analytical skills and high attention to detail

Desirable

Demonstrated knowledge of clinical and pharmaceutical drug development process
Demonstrated understanding of clinical data system design / development / validation and system interoperability.
Demonstrated ability to work effectively with external partners
Understanding of database structures, programming languages, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting
Knowledge of SQL or SAS software
Experience leading clinical studies as Data Management Lead


#J-18808-Ljbffr