Data Coordinator (Clinical Trials)

Sun Pharmaceuticals, Inc; United States; Remote; USD 70,000 - 90,000; Full time

Job summary

A leading pharmaceutical company seeks a Database Coordinator for Clinical Research in the United States. The role requires a Pharmacy or Science Post-Graduate with at least 5 years of experience in clinical data management. Responsibilities include preparing start-up documents, managing discrepancies, and ensuring timely database lock. Join us to make a lasting impact and grow in a supportive environment.

Benefits

Robust benefits

Opportunities for growth

Qualifications

• At least 5 years of experience in clinical data management in Pharma/CRO industry.

Responsibilities

• Preparation & Review of start-up documents.
• Preparation of Edit Specification Document, Test Plan, and Data Entry Guideline.
• Screen design UAT and Edit checks UAT.
• Discrepancy management and timely completion of database lock.

Skills

Experience in development of data management documents

Development of validation plan

Screen UAT and edit check UAT

Clinical data query management

Education

Pharmacy / Science Post-Graduate

Job description

Overview

Database Coordinator (Clinical Research) – Mumbai

At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you will find yourself becoming better every day through continuous progress. Exhibit self-drive as you take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we thrive together and support each other’s journeys.

Key responsibilities

• Preparation & Review of start-up documents: eCRF completion guidelines, DMP, SAE reconciliation plan, clinical coding plan
• Preparation of Edit Specification Document (ESD), Test Plan and Data Entry Guideline
• Screen design UAT
• Edit checks UAT in CDMS as per ESD
• Discrepancy management
• Support Data Manager in URS review for IWRS
• Ensure timely completion of SAE reconciliation activities
• Ensure timely completion of closeout activities including database lock
• Preparation and update of Master Data Management File to ensure its completeness
• Preparation & Review of Data Management Report

Qualifications

Educational Qualification

Pharmacy / Science Post-Graduate

Experience

At least 5 years of experience in the clinical data management domain in Pharma/CRO industry

Additional Skills

• Experience in development of data management documents, development of validation plan, screen UAT, edit check UAT, clinical data query management, etc.

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Lets create a brighter future together!

Disclaimer

The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.