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Senior Data Manager

OPIS, Clinical Research Organization (CRO), United Kingdom

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 pride ourselves on providing state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of projects. Our extensive expertise covers all phases of drug-related trials, ensuring that we take care of our Sponsors beyond the therapeutic area by offering accurate clinical investigations for medical and diagnostic devices. With Global Clinical Research Locations worldwide, OPIS provides a full range of integrated clinical research services such as scientific advice, medical writing, trial start-up, monitoring, study management, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture, quality assurance, and training.

We are currently looking for an experienced Senior Data Manager to join our team as the primary point of contact for clinical data-related matters. In this role, you will be responsible for ensuring that data management for clinical studies complies with regulatory guidelines, standards, and company SOPs. Key responsibilities include overseeing database design, data cleaning processes, database lock activities while mentoring junior staff members and driving innovation within the team. The ideal candidate will have a Bachelor’s degree along with a minimum of 7 years of experience in CRO or related industries or at least 3 years in a similar role. Strong knowledge of ICH-GCP, ISO14155 standards is required along with proficiency in relational databases and SAS being a plus.

As part of our team at OPIS, you will enjoy a competitive salary with additional benefits/bonuses along with the opportunity to develop your professional career within an expanding and growing company. If you possess a strong commitment to quality work along with excellent planning skills and teamwork abilities while being fluent in English (reading, writing & verbal), we encourage you to apply for this position. Join us in leading study-specific meetings and providing training to project teams while promoting the use of digital technologies and innovative tools to ensure timely deliverables on various projects across different locations globally.

If you are looking to further your career in the clinical research industry by taking on a challenging yet rewarding role as a Senior Data Manager within an internationally recognized CRO like OPIS that values innovation and excellence in service delivery across various healthcare sectors including pharmaceuticals and medical devices studies – then we would love to hear from you! Apply now to become part of our dynamic team where your skills will be valued and nurtured towards achieving both personal growth as well as contributing significantly towards advancing global healthcare initiatives through cutting-edge clinical research practices.

Key Job Requirements:
  • 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
Key Job Responsibilities:
  • Ensure compliance with CDISC standards, regulatory guidelines, and internal SOPs
  • Prepare and validate Data Management documents
  • Oversee coding of medications and medical terms
  • Act as main liaison with Sponsors and external stakeholders
Skills:
  • Data management
  • Regulatory compliance
  • Clinical database setup
  • Quality control
  • Project management

Seniority Level: Senior Level

  • Middle Management
  • Executive Level

Job Functions: Data Management

  • Clinical Data Management
  • Database Design

Industries : Clinical Research Organization (CRO)

  • Biotechnology
  • Pharmaceuticals

More Clinical Data Management , Database Design jobs in United Kingdom

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