Senior Clinical Data Scientist at Bioforum the Data Masters

Minimum requirements:

Bachelor’s degree or above in a biomedical or science discipline and equivalent experience is required.

Minimum experience:

At least 4 years of proven experience in a clinical research environment (Specifically data management field). 

Minimum requirement/skills:

• Knowledge of the clinical trial process flow
• Knowledge of data management principal, processes, and Electronic Data Capture (EDC) systems
• Knowledge of medical terminology, pharmacology, anatomy and/or physiology
• Knowledge of Good Clinical Practices and relevant regulatory guidelines

Minimum requirement/competencies:

• Proficient in English
• Ability to exercise excellent attention to detail
• Ability to take initiative and work independently
• Ability to establish and maintain effective working relationships with co-workers and managers
• Excellent interpersonal and communication skills, both verbal and written
• Strong problem-solving skills
• Good organizational, planning and time management skills (Administrative skills)
• Excellent computer skills
• Proficient in Microsoft Office products.

Responsibilities:

• Responsible for performing activities that are in compliance with applicable Business Practices, Standard Operating Procedures and Working Instructions and performing other duties as assigned by management
• Collaborate with Project Managers in study documents and deliveries, leading other data managers in the process
• Review study specific protocols and assist in the design of CRF utilizing company and/or sponsor data standards as applicable, collaborating with Project Managers and Head of Data Operations 
• Collaborate in Data Management Plan creation  
• Understand and comply with all applicable sections of Data Management Plan
• May lead the process in defining study specific Data Checks (automated and manual) 
• Leading/hands on study data review for a study including clinical database and external data according to Project Manager guidance and the study scope of work
• Lead data validation efforts prior to go live and as applicable during study
• Develop and maintain good communication and working relationships with CDM team
• Stand in as back-up to the Project Manager
• Responsible for resource planning on assigned projects
• Ensure clinical trial data completeness, integrity, and consistency 
• Oversight on DM activities meet the requirements set by scope of work and budget.
• Lead Quality Control procedures
• Ensure all study documents are saved under the relevant study files
• Supervise, Mentor and Train other Data management employees
• Contribute to departmental SOP development 
• Provide support on CDM Initiatives and Process improvements