Senior Data Manager

OPIS s.r.l.; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

An established industry player is looking for a Senior Data Manager to lead clinical data management efforts. In this fully remote role, you will serve as the primary contact for data-related matters, ensuring compliance with regulatory standards and driving innovation. Your responsibilities will include database design, data cleaning, and mentoring junior staff while managing key interactions with sponsors and stakeholders. This position offers a competitive salary and opportunities for professional growth in a dynamic environment. If you are passionate about data management and want to make a significant impact in clinical studies, this is the perfect opportunity for you.

Qualifications

• Minimum of 7 years in CRO, biotech, or pharma.
• Strong knowledge of ICH-GCP and data management regulations.

Responsibilities

• Ensure compliance with CDISC standards and regulatory guidelines.
• Lead database design, data cleaning, and oversee database lock.

Skills

Data Management

Regulatory Compliance

Project Management

Communication Skills

Teamwork

Education

Bachelor's Degree in Life Sciences or related field

Tools

SAS

Microsoft Office

Job description

We are seeking an experienced Senior Data Manager to serve as the primary point of contact for clinical data-related matters. You will ensure that data management for clinical studies complies with regulatory guidelines, standards, and company SOPs. The Senior Data Manager will lead key activities, including database design, data cleaning, and database lock, while mentoring junior staff and driving innovation.
This is a fully home based role in one of the countries where OPIS has its affiliate office.

Key Responsibilities:

• Ensure compliance with CDISC standards, regulatory guidelines, and internal SOPs.
• Prepare and validate Data Management documents (Data Management Plans, Data Validation Documents, Data Transfer Specifications).
• Design paper Case Report Forms (CRFs) and validate electronic CRFs.
• Define study specification for clinical databases setup and validate.
• Manage database changes, perform data cleaning, and oversee coding of medications and medical terms.
• Oversee database lock and freeze prior to data analysis.
• Perform quality control and participate in study audits/inspections.
• Act as the main liaison with Sponsors and external stakeholders on data management activities.
• Lead study-specific meetings and provide training to the project team.
• Mentor junior staff and promote the use of digital technologies and innovative tools.
• Track project milestones to ensure timely deliverables.

Qualifications:

• Minimum of 7 years of experience in CRO, biotech, or pharma, or 3 years in a similar role.
• Strong knowledge of ICH-GCP, ISO14155, and data management regulations.
• Knowledge of relational databases and SAS (a plus).
• Proficient in Microsoft Office.
• Strong commitment to quality, with excellent planning, communication, and teamwork skills.
• Fluent in English (reading, writing, and verbal).

What We Offer:

We offer a competitive salary with other benefits/bonuses and opportunity to develop your professional career with an expanding and growing company.