Are you looking to play an integral role in the future of medicine across the globe? If so, this may be the opportunity for you!
We are currently looking to attract a Data Coordinator in Gdynia.
This role will be responsible for working on some projects and therapeutic areas in support of clinical protocols, data analysis and compliance with regulatory requirements.
The Data Coordinator also has the ability to develop data entry and data cleaning processes, provides good quality data, ensures data is entered according to timelines, track CRF and query totals for projects.
Key roles and responsibilities of the Clinical Research Data Coordinator are :
To coordinate multiple projects whilst ensuring all study documentation is accurate and up to date with correct versions.
Following guidelines for the data entry process for studies
Maintain a database to track the flow of CRFs and queries
Assist in training junior staff in activities and processes, as called upon
Analyse trends and inconsistencies on projects worked upon, resolve issues to enhance overall performance
Strive to achieve own personal development and continuous service improvement to the business
Be site Lead DC on projects and deliver projects on time and to the client’s satisfaction.
Work with the systems in place to deliver good quality data ensuring source documents are accurate
Create good relationship with customers and ensure high level of customer service
Work with CRAs to ensure that issues are dealt with appropriately and highlight findings to Site Data & Quality Manager / Clinical Data Coordinator III
Work with the Core Study Team to ensure that objectives and goals for site and study are being achieved
Work to SOP / COPs and GCP guidelines
Perform quality control as described in the relevant Synexus procedure and as applicable to the role
Support other duties as assigned e.g. named study archivist
Maintain CRA relationships, adherence to departmental process improvement initiatives, targets and delivery of study targets
To be considered for this exciting, challenging opportunity you will need the following skills and experience :
A good level of relevant work experience with increasing responsibility in data management with knowledge of two therapeutic areas
Demonstrated time management skills and ability to adhere to project productivity metrics and time lines
Knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations
Working knowledge of the relationship and regulatory obligation of the industry with pharmaceutical biotechnological companies and CRO’s
Working knowledge of English is preferred
Demonstrated ability to work in a team environment and collaborate with peers
Demonstrated interpersonal skills
Appropriate MS Office skills, EDC, eCRF
Good organisational and planning skills
Good oral and written communication skills
Work with CRAs and assist on following up on audit findings
A strong team player, with excellent organisational and problem solving skills and the ability to work independently.
Able to multi-task and work well within a high pace pressurised environment.