Senior Data Manager

Job title:

Senior Data Manager

Company:

OPIS

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.Key Responsibilities:

• Ensure compliance with CDISC standards, regulatory guidelines, and internal SOPs.
• Prepare and validate Data Management documents (CRFs, Data Management Plans, Data Transfer Specifications).
• Design and validate both paper and electronic Case Report Forms (CRF) and clinical databases.
• 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:

• Bachelor’s degree.
• 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, CDISC standards, 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.Please read the information notice on the processing of personal data in the candidates information section of our company website.Who we are:OPIS is an International CRO with 25 years of experience in conducting Phase I-IV, non-interventional and medical devices studies on an international level. We always offer state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of projects.
OPIS extensive expertise covers all phases of drug-related trials, taking care of the Sponsor beyond the therapeutic area, offering also accurate clinical investigations for medical and diagnostic devices. With Global Clinical Research Locations all over the world, OPIS offers a full range of integrated clinical research services as scientific advice, medical writing, trial start-up, monitoring, study management, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture as well as quality assurance and training.Powered by JazzHR

Expected salary

Location

Polska

Job date

Tue, 22 Oct 2024 23:15:46 GMT

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