Location: Remote, India
Industry: Pharma/Healthcare/Clinical Research
Functional Area: Data Management
Job ID: R0000028183
Application Deadline: 30th October 2024
About PAREXEL: PAREXEL is a leading global biopharmaceutical service provider, dedicated to supporting the development of new drugs and treatments. With a strong presence in the Bio-Tech and Pharmaceutical industries, we offer a range of knowledge-based contract research, medical communications, and consulting services across various therapeutic areas.
Position Overview: As a Clinical Data Analyst II (CDA II), you will work under the guidance of your Line Manager and Subject Matter Experts. This role involves performing clinical data cleaning activities, supporting data processing tasks, and ensuring compliance with corporate quality standards and regulatory requirements.
Key Responsibilities:
Data Validation and Cleaning:
- Lead and manage data cleaning and review activities, including query management and manual/SAS listing reviews.
- Support data processing activities from database setup to database lock, including external vendor data reconciliation.
Data Management Documentation:
- Assist in setting up Data Management documents and ensure compliance with SOPs and ICH/GCP guidelines.
Study Start-Up Activities:
- Conduct user acceptance testing (UAT) on clinical database setups.
- Review protocols and EDC Entry Screens as necessary.
Data Tracking and Entry:
- Track and review Case Report Forms (CRFs) and support data entry as needed.
Quality Management & Compliance:
- Ensure adherence to SOPs and ICH/GCP guidelines.
- Support and lead functional quality control activities on databases and patient data.
Training:
- Maintain compliance with training requirements related to assigned job roles.
- Identify and address training needs based on developmental goals.
Qualifications:
Skills:
- Strong problem-solving abilities and logical reasoning skills.
- Commitment to quality, with meticulous attention to detail.
- Effective time management and prioritization capabilities.
- Ability to collaborate effectively within a team.
- Excellent interpersonal, oral, and written communication skills.
- Quick learner with a proactive approach to knowledge sharing.
- Adaptable to changing environments and assignments.
- Accountability regarding job responsibilities.
Candidate Profile:
- Bachelor’s degree or equivalent medical qualifications; relevant industry experience preferred.
- Familiarity with Microsoft Office and basic computer skills.
- Basic understanding of data management processes and data validation workflows.
- Knowledge of ICH-GCP guidelines and local regulatory requirements.
- Experience with Clinical Data Management Systems (e.g., InForm, Rave, Veeva).
- Basic understanding of clinical study team roles within data management.
- Experience in the clinical research industry is a plus.
- Familiarity with medical terminology and coding dictionaries (e.g., MedDRA, WHODRUG).
Why Join PAREXEL? At PAREXEL, we offer an innovative environment where you can grow your career while making a significant impact in the biopharmaceutical field. If you are passionate about clinical data management and want to contribute to life-changing research, we encourage you to apply.
Application Instructions: Please submit your resume and cover letter through our careers page, referencing Job ID R0000028183.