Senior Data Manager

Optimapharm d.o.o.
3 days ago

Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Working hours
Regular working hours
Languages
English
Experience level
Intermediate

Job location

Remote

Tech stack

Bioinformatics
Clinical Data Management
Databases
Coherent Remote File System (CRFS)
Data Cleansing
R
Python
SAS (Software)
SQL Databases
Vba Programming Language
Data Management
Programming Languages

Job description

  • Lead and oversee end-to-end data management activities across assigned clinical studies
  • Ensure data accuracy, integrity, and compliance with study protocols and regulatory standards
  • Develop, review, and maintain key data management documents (DMPs, CRFs, edit checks, transfer specs)
  • Design, test, and validate EDC systems and related databases, including user acceptance testing
  • Manage and coordinate data cleaning, reconciliation, and database lock activities
  • Perform and oversee medical coding of adverse events and medications using standard dictionaries
  • Act as the main point of contact for sponsors, vendors, and internal project teams
  • Provide leadership, guidance, and mentorship to data management team members
  • Participate in audits, inspections, and quality improvement initiatives
  • Monitor project timelines, deliverables, and KPIs, ensuring on-time and within-budget delivery
  • Contribute to process harmonization, SOP development, and adoption of best practices
  • Stay current with industry trends, technologies, and regulatory updates in clinical data management

By joining our fast-growing and prosperous team, you will have a great opportunity for further personal growth and career development.

Requirements

Do you have experience in Visual Basic?, Do you have a Master's degree?, * Bachelor's or higher degree in a biomedical or technical field (e.g., Biology, Biostatistics, Bioinformatics, Engineering) or equivalent industry experience

  • 3- 5 years of proven experience in Clinical Data Management within CRO, pharma, or biotech settings.
  • Knowledge of GCP and ICH Guidelines
  • Experience in driving process or technology enhancements; background in supporting business development initiatives is considered as an advantage
  • Strong understanding of quality systems and regulatory compliance
  • Proficient in EDC systems and database standards (e.g., SQL); knowledge of programming languages such as Python, R, SAS, or VBA is an advantage
  • Excellent analytical, organizational, and problem-solving skills
  • Effective communicator and team player with the ability to manage multiple projects and deadlines

Benefits & conditions

Compensation is competitive and final offers will reflect each candidate's experience, skills, and qualifications.

About the company

Optimapharm is a globally operating, leading, mid-sized, full-service CRO aiming to deliver new therapies to improve and save patients' lives. Optimapharm' s key priorities are the well-being of our people, consistent quality delivery to our clients and healthy, sustainable growth. With 26 strategically located offices, Optimapharm operates in 40+ countries, providing most optimal access to Patients and Investigators globally. Established nearly 20 years ago, we leverage our experience, stable project teams and collaborative, and flexible approach to secure a high level of repeat business, gain the trust of new customers and secure continued growth of the company. As a Senior Data Manager at Optimapharm, you'll be at the forefront of driving data excellence in clinical research. You won't just manage data; you'll lead projects, guide teams, and shape the standards that ensure our studies deliver reliable, meaningful results. Partnering closely with cross-functional experts, you'll play a critical role in transforming complex clinical data into insights that advance science, support our sponsors, and ultimately improve patients' lives worldwide.

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