Manager, Clinical Data Sciences

Premier Research; Bengaluru; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Premier Research is seeking a Manager, Clinical Data Sciences to lead data management in our Clinical Data Sciences team. You will work with biotech, medtech, and pharma partners to drive data strategy, quality, and delivery in life sciences programs.

The role requires advanced expertise in data management, regulatory standards, and supervising a team of data coordinators. You will mentor staff, manage project plans, and ensure timely delivery of database setup, data cleaning, and analysis

Qualifications

• 12+ years mastery in data management, with at least 4–7 years of supervisory/management experience.
• Experience with clinical data management systems, preferably Medidata Rave or Calyx EDC.
• Familiar with all phases of a study, e.g., pre-award, startup, maintenance and lock.
• Knowledge of data mining and the application of data standards.
• End-to-end operational management and delivery ownership.
• Budget management and financial awareness.
• AI initiatives and implementation.

Responsibilities

• Serves as primary Clinical Data Sciences contact in assigned studies and ensures data cleaning is performed consistently.
• Coordinates all tasks within the data science process between team members from database development to database lock.
• Prepares data science plans, data entry guidelines, data science reports and related documents for databases.
• Supports database development activities and coordinates amendments with the database development team.
• Provides leadership and advice to Data Coordinators and trainees on procedures, SOPs, and ICH-GCP.
• Provides and/or coordinates training and mentoring of DCs and trainees.
• Assists with performance assessments, career development, and end-of-probation reviews.
• Onboards, trains, and evaluates new employees to facilitate department integration and utilization targets.
• Supports department management in resource planning, hiring, and achievement of financial goals.
• Directly manages a team of Lead Data Scientists and other Clinical Data Sciences staff as assigned.

Skills

Data management

Leadership

Regulatory knowledge

Data standards

Mentoring/training

Tools

Medidata Rave

Calyx EDC

Job description

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.

What you’ll be doing:

• 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

What we’re looking for:

• 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

• Performance management (goal setting, reviews, continuous feedback)

• Process improvement and driving key initiatives

• Budget management and financial awareness

• AI initiatives and implementation