Senior Data Manager

OPIS, an International Clinical Research Organization (CRO) with 25 years of experience in conducting Phase I-IV clinical studies globally, is currently looking for a skilled Senior Data Manager. At OPIS, we pride ourselves on offering cutting-edge information technology solutions and innovative approaches to a diverse range of projects. Our mission is to provide high-quality clinical research services across different therapeutic areas while maintaining a strong focus on client satisfaction and regulatory compliance.

As the Senior Data Manager at OPIS, you will play a crucial role in ensuring that clinical data management activities align with regulatory guidelines, industry standards, and company protocols. Your responsibilities will include overseeing database design, data cleaning processes, database lock procedures, and mentoring junior staff members. You will serve as the main point of contact for all data-related matters in clinical studies, liaising with sponsors and external stakeholders to ensure seamless communication throughout the project lifecycle.

To excel in this role, you must possess a Bachelor's degree along with a minimum of 7 years of experience in CRO, biotech, or pharma industries (or 3 years in a similar position). Proficiency in CDISC standards, ICH-GCP guidelines, ISO14155 regulations, relational databases, and SAS would be advantageous. Additionally, strong planning, communication, teamwork skills are essential for success in this role. Fluency in English (reading, writing, verbal) is required to effectively communicate with internal and external stakeholders.

At OPIS, we offer a competitive salary along with other benefits and bonuses as part of our commitment to supporting the professional growth of our employees. This position presents an excellent opportunity for experienced professionals looking to advance their careers within a dynamic and rapidly expanding organization like ours. If you are passionate about data management in clinical research settings and eager to contribute to innovative projects on an international scale, we encourage you to apply for the Senior Data Manager position at OPIS today.

• Minimum of 7 years of experience in CRO, biotech, or pharma
• 3 years in a similar role
• Experience with clinical data management
• Bachelor’s degree
• Strong knowledge of ICH-GCP, ISO14155, and data management regulations
• Proficient in Microsoft Office

• Ensure compliance with CDISC standards, regulatory guidelines, and internal SOPs
• Prepare and validate Data Management documents
• Oversee coding of medications and medical terms
• Mentor junior staff

• Data management
• CDISC standards
• Regulatory guidelines
• Database design
• Data cleaning

Seniority Level: Senior Level

• Middle Management
• Executive Level

Job Functions: Data Management

• Clinical Data Management
• Database Design
• Data Cleaning

Industries : Healthcare

• Pharmaceuticals
• Clinical Research