We are a Belgrade based team creating products that evolve traditional approaches and enable implementation of more sophisticated engineering processes in the different phases of clinical trials. Our team consists of experts working on the full life cycle of product development - from sparking initial idea to business priority scoping, competition analysis, user testing, all leading to software design and development. Our key focus is building a new enterprise distributed platform and new set of products, bringing innovation in the domain that will work as an ecosystem of well connected and integrated applications and microservices. Together with our partners we are working on solving problems that will enable a more efficient, synergetic, fast and secure clinical trial process.
We are looking for a Clinical Data Manager who will be responsible for reviewing and evaluating clinical data generated from the imaging portion of sponsor clinical trials conducted in various therapeutic areas. Working from this role you will get the chance to work with our clients team on ensuring complex requests are met and that our service is in line with services and standards of ecosystem.
Here’s what you will be doing:
- Ensures clinical trial databases meet project requirements by:
- Performing all data management deliverables for assigned studies
- Attending and participating in client meetings as requested
- Ensures the plan for data management is properly executed by:
- Understanding the requirements for study implementation and data collection
- Collaborating with project team to develop study-specific edit check criteria
- Defining, running, and reviewing edit checks and resolving discrepant data
- Maintaining organized, complete, and up-to-date study documentation
- Performing study setup, including TF design, database structure, specifications, and obtaining and providing approvals as needed
- Coordinating and documenting the receipt and processing of electronic or ancillary data received from outside sources (e.g., data received from other central laboratories, CRO's, or Sponsors).
- Keeping supervisor informed of project status
- Ensures the accuracy and consistency of clinical databases by:
- Reviewing data and identifying errors/inconsistencies
- Collaborating with appropriate project team to resolve data issues
- Tracking outstanding issues and following-up until resolution
- Ensuring accuracy in manipulation and scrutiny of clinical data and that CDM activities are carried out according to regulatory guidelines
- Maintains Quality Service and Departmental Standards by:
- Adhering to all clients Clinical Data Management (CDM) procedures, policies, and work instructions
- Reading, understanding and adhering to applicable Standard Operating Procedures (SOPs)
- Assisting in establishing and enforcing departmental standards
- Participating in the review and updating of company SOPs related to DM Services Contributes to team effort by:
- Working with internal staff to resolve issues
- Exploring new opportunities to add value to the organization
- Helping others to achieve results
- Performing other duties as assigned
- Maintains Technical and Industry Knowledge by Attending and participating in applicable company-sponsored training
It would be great if you would have:
- Bachelor’s degree in Computer Science, Life Sciences or related field preferred, or equivalent experience required
- 1+ years’ experience in comparable position within the pharmaceutical, biotech or CRO industry recommended
- Working knowledge of relational database organization and validation
- Familiarity with SAS desirable
- Experience working with office productivity tools including Word, Excel and Access preferred
- Understanding of clinical trial terminology desirable
- Proven ability in problem solving
- Ability to work independently in a group setting; ability to adjust to changing priorities
- Excellent attention to detail
- Strong interpersonal and communication skills, both verbal and written
- Strong documentation and organisational skills
Join our team as we push boundaries and bring innovation in the field of life sciences. At the core of our vision is one goal, and that is creating end-to-end products that enable our clients to focus on what they do best - discover novel types therapies. As a strongly focused, distributed team we are driven by enthusiasm for working on cutting edge solutions and problems. We are led by problems we must solve to enable our clients amazing breakthroughs in clinical trial phases. If you want to join our mission driven team working on enabling faster improvements in drug discovery send us your CV.
