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Senior Data Manager

1 month ago

Batu Pahat, Johor, Malaysia OPIS Full time
Senior Data Manager

5 days ago Be among the first 25 applicants

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:
  • 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 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.

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.

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