Serves as primary Clinical Data Sciences contact in assigned studies and ensures that data cleaning is performed in a consistent way between team members
Coordinates all tasks within the data science process between different team members from database development to database lock
Prepares data science plans, data entry guidelines, data science reports and other documents required for preparing and completing databases
Supports database development activities and coordinates database amendments in collaboration with the database development team
Provides leadership and advice to Data Coordinators (DCs) and trainees on Clinical Data Science procedures, SOPs, ICH-GCP
Provides and/or co-ordinates training and mentoring of DCs and trainees
Helps to assess DC performance and execute annual appraisals, monitors career development, and performs end-of-probationary-period reviews
Onboards, trains, and evaluates new employees to facilitate integration into the department and to reach target utilization in a timely manner
Supports department management in resource planning and allocation; hiring and management of data management staff; and achievement of department financial goals
Directly manages a team of Lead Data Scientists and other Clinical Data Sciences staff as assigned
Requirements
12+ years mastery in data management experience, with at least 4 - 7 years of supervisory/management experience. Minimum of 3 years of experience in leading studies.
Experience working across clinical data management systems and in-depth knowledge of at least one, preferably Medidata Rave or Calyx EDC
Familiar with all phases of a study, e.g., pre-award, study startup/database setup, maintenance and lock
Knowledge of data mining and the application of data standards
End-to-end operational management and delivery ownership
Premier Research is looking for a Manager, Clinical Data Sciences to join our Clinical Data Sciences team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
Premierresearch · Bangalore, India