Data Manager

hace 6 días

Barcelona, Barcelona, España Optimapharm d.o.o. A tiempo completo
About Optimapharm d.o.o.

Optimapharm d.o.o. is a leading, mid-sized, full-service Contract Research Organization (CRO) working across Europe and North America to deliver new therapies to improve and save patients' lives.

We are a company that prioritizes our people and consistently exceeds our clients' expectations.

With 27 strategically located offices, we operate in 40+ countries, giving us unrivaled access to patients and investigators in all countries in Europe and North America.

Our in-depth expertise and long-standing experience, combined with a flexible and collaborative approach, allow us to optimize design and planning; through our strong track record of delivery excellence and committed and stable project teams, we have secured a high level of repeat business over the years.

Job Summary

We are seeking a highly skilled Data Manager to join our Data Management team in Spain.

The ideal candidate will have a strong background in data management, excellent technical knowledge, and experience working with clinical research organizations, pharmaceutical companies, or biotech companies.

The Data Manager will be responsible for working on ongoing clinical studies to ensure results are consistent with expectations and quality control procedures are followed.

Key Responsibilities
  • Working on ongoing clinical studies to assure results are consistent with expectations, and quality control procedures are followed
  • Participating in the creation and review of key data management documents, including CRF Specifications, Case Report Forms, Data Transfer Agreements/Specifications, Data Management Plans, Data Cleaning Plans, and eCRF Completion Guidelines
  • Preparing reports, listings, resource allocation forecasts, and other documents
  • Writing specifications for the set-up and modification of electronic data capture systems and other clinical databases
  • Working with vendor System Administrators/Programmers to develop, test, and validate all project-specific programming (if required)
  • Performing verification and User Acceptance Testing of electronic data capture systems and other clinical databases
  • Defining, writing, and validating Manual and Automatic edit checks for clinical data cleaning
  • Supporting all data cleaning activities for assigned projects
  • Specifying and reviewing patient listings/tables for clinical data cleaning
  • Performing reconciliation of data from external sources
  • Coordinating database locks, performing data review meetings in collaboration with required project team members and Sponsor
  • Performing activities such as executing unblinded data exports from EDS and creating the IP inventory management setup with supervision
  • Performing medical coding using industry-standard dictionaries
  • Applying company standards and actively participating in improvements towards harmonization and standardization across projects
  • Participating in the creation and maintenance of the Data Management eCRF library
  • Initiating and/or participating in the improvement, development, and review of Company's Controlled Documents
  • Participating as necessary in sponsor qualification, sponsor audits, regulatory authority inspections, and other third-party meetings
  • Entering and updating data in relevant CTMS modules timely and accurately
  • Participating in Optimapharm resource planning activities, if requested
Requirements
  • BS or higher degree in a bio-medical or technical discipline, such as Biology, Biochemistry, Medicine, Biostatistics, Mathematics, Bioinformatics, or Engineering, or relevant experience in the industry
  • At least 3-4 years of experience in data management in Contract Research Organizations, pharmaceutical companies, biotech companies, or similar
  • Excellent technical knowledge and experience with JavaScript, C, and Python
  • Good knowledge of GCP and ICH Guidelines
  • Good knowledge of the English language, spoken and written
  • Ability to communicate effectively with appropriate internal and external contacts
  • Ability to work on multiple projects and manage project timelines
  • Good organizational and time management skills and initiative
  • Good communication and presentation skills
  • Ability to define problems, collect data, establish facts, and draw valid conclusions
What We Offer
  • Working in a successful company that's growing and developing every day
  • Working with a highly experienced team of clinical research professionals
  • International projects and professional growth
  • Competitive salary and performance bonus
  • Premium Health insurance
  • Training opportunities
  • Work from home (and allowance)
  • Flexible work hours

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