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
IntermediateJob 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.