Senior Clinical Data Coordinator (Poland)

Description The Senior Clinical Data Coordinator will participate in various clinical data management activities required to ensure that data captured in clinical trials undertaken, or managed by Indero, are collected, managed, and reported clearly, accurately and securely. In addition, this position is required to conduct all these activities in conformance with applicable regulatory requirements, industry guidelines, and Innovaderm standard operating procedures (SOPs) while respecting Indero’s commitment to sponsor’s requirements and timelines.

More specifically, the Senior Clinical Data Coordinator must:

More specifically, the Senior Clinical Data Coordinator must:

Adhere and promote company organizational values and related expected behaviors, follow company SOPs and processes for all deliverables, and ensure all trainings assigned to oneself are completed on time.

Support Lead Data Manager in the areas of:

• Data Review, including but not limited not running SAS programs and using compare programs, and reviewing manual listings, and adding/closing queries in EDC.
• Data Reconciliation, including but not limited to adding queries in EDC, and reporting issues in the data clarification log.
• Discrepancy Management (e.g.:adding and closing queries).
• Reporting potential protocol deviation.
• Marking the forms/subjects as DM reviewed, or Soft Locked
• Maintenance of Study Metrics; Monitoring study status (e.g. enrollment, CRFs monitored/approved, etc.) on an ongoing basis and provide data status reports to the project team, as needed.
• Generation of Ad-Hoc Study Reports (e.g. Central Monitoring reports).
• Performing User Acceptance Testing.
• Entering dummy data in development environment.
• Ensuring that data management documentation is complete and uploading documents in the trial master file (TMF).

Creating data management plan (DMP), eCRF Completion Guidelines, and other clinical data management related documentation. Assist with reviewing statistical data issues reported by Statistical programmers or Lead Biostatistician. Provide basic support to other Clinical Data Coordinators, as needed. Contribute to the identification of future internal initiatives to increase efficiency/quality of data cleaning activities.

May also:

• Act as a back-up for the Lead Data Manager during short periods.
• Assist in writing test cases.
• Help in allocating CDC resources for UAT testing or any other CDC's activities.
• Mentor more junior Clinical Data Coordinators.
• Participate in internal initiatives to increase efficiency/quality of data cleaning activities.
• Assist Lead Data Managers in reviewing/validating initial manual listings.

Requirements

• B.Sc. or related field.

1 to 3 years of clinical data management experience in the biotechnology, pharmaceutical or contractual research organization (CRO) industry.

• Skilled in use of computer technology and ability to learn new applications.
• Highly organized and detail-oriented with effective project planning and time management skills.
• Strong verbal and written communication skills in English, French an asset.
• Ability to work in a fast-paced environment with demonstrated agility to organize and prioritize multiple competing demands.
• Very good interpersonal, communication, problem solving and organizational skills with the ability to work both independently and in a team environment.
• General knowledge of CDISC standards (CDASH/SDTM) an asset.

Understanding of the drug development process and of applicable regulations, including Good Clinical Practices, ICH Guidelines, GCP, applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines an asset.

Our company The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

In this position, you will be eligible for the following perks:

Permanent full-time position Flexible schedule Vacation Home-based position Ongoing learning and development

Work location The successful candidate for this position is given to work remotely anywhere in Poland.

Employees located outside of North America are expected to have some flexibility in their working hours to accommodate team or client meetings as needed. All efforts will be made by Indero to accommodate various time zones of team members.

About Indero

A Global Clinical Leader In Dermatology!

Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.

Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in Poland.

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