Manager, Clinical Data Sciences

30 Premier Research Group (India) Private Limited; Bengaluru; On-site; INR 3,000,000 - 6,000,000; Full time

Job summary

Premier Research invites a seasoned Manager, Clinical Data Sciences to lead data management initiatives across studies, ensuring high-quality data and compliant processes. You will coordinate cross-functional teams from data collection to database lock, driving standardization and mentoring junior staff.

The role requires extensive experience in clinical data sciences, strong leadership, and hands-on knowledge of data standards and systems like Medidata Rave or Calyx EDC.

Qualifications

• 12+ years mastery in data management, with 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.

Responsibilities

• Serves as primary Clinical Data Sciences contact in assigned studies and ensures that 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 other documents for databases.
• Supports database development activities and coordinates amendments with the development team.
• Provides leadership and advice to Data Coordinators and trainees on Clinical Data Science procedures and SOPs.
• Provides and/or coordinates training and mentoring of DCs and trainees.

Skills

Data management

Team leadership

Study leadership

Medidata Rave / Calyx EDC

ICH-GCP familiarity

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
• Assesses DC performance and executes 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

Premier Research is more than a company - it's a community furthering research to improve the lives of patients in critical need. We are a diverse staff thinking creatively, challenging ideas, and solving complex problems. Our Values - We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care - mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location. Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning. Introduce yourself to our Talent Team and we will reach out if there is a role that aligns with your experience and interests. Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose. Premier is a place where you can change lives, and feel rewarded and celebrated. We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.