Location: Remote / Mumbai. Bangalore & hyderabad
Parexel is a global clinical research organization (CRO) dedicated to improving world health by providing clinical development solutions. With expertise spanning clinical trials, regulatory affairs, and market access, Parexel plays a crucial role in bringing innovative therapies to market. The company values collaboration, integrity, and excellence, ensuring that each employee contributes to improving patient care and advancing medical research.
Open Positions at Parexel
1. Senior Clinical Database Programmer
Responsibilities:
- Set up, maintain, revise, and close out Electronic Data Capture (EDC) systems.
- Supervise and create database setups for clinical data management systems (CDMS).
- Develop and implement consistency checks for database builds in compliance with CDISC standards.
- Ensure first-time quality in all deliverables.
- Liaise with sponsors, Data Management Leads, and other stakeholders to resolve technical issues.
- Lead and support programming activities related to clinical systems and eClinical technologies.
- Maintain study documentation per regulatory guidelines.
- Provide mentorship and training to junior team members.
- Participate in business development and bid defense meetings.
Qualifications:
- Bachelor’s degree in a relevant science discipline (or equivalent experience).
- Strong knowledge of programming environments like SAS, CDMS, EDC, SQL, VB, or Java.
- Experience working with clinical trial systems (e.g., RAVE, DataLabs, Medrio, Veeva, CTMS, Medical Safety Reporting).
- Understanding of Software Development Life Cycle (SDLC), GCP, and regulatory guidelines (21 CFR Part 11, ICH-GCP).
- Ability to lead teams and work independently in a global environment.
Skills Required:
- Strong collaboration and leadership abilities.
- Excellent problem-solving and decision-making skills.
- Ability to work in an evolving technical environment.
- Proficiency in time management and prioritization.
- Strong oral and written communication skills.
2. Clinical Data Analyst II
Responsibilities:
- Lead and manage clinical data cleaning and review activities.
- Conduct query management and review of protocol deviations.
- Perform data processing activities from setup to database lock.
- Conduct user acceptance testing (UAT) for study database setups.
- Support CRF tracking and data entry processes.
- Develop and maintain Data Management (DM) documents.
- Perform functional Quality Control (QC) activities.
- Mentor and support junior team members.
- Ensure compliance with global regulatory standards.
Qualifications:
- Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
- Prior experience in clinical data management and database programming.
- Understanding of clinical trial regulations, including ICH-GCP and 21 CFR Part 11.
- Experience with data validation and reconciliation processes.
Skills Required:
- Strong data analysis and problem-solving skills.
- Excellent written and verbal communication skills.
- Ability to work in a fast-paced and regulated environment.
- Detail-oriented with a commitment to data quality.
