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Description
The 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 Indero standard operating procedures (SOPs) while respecting Indero ’s commitment to sponsor’s requirements and timelines.
This role will be perfect for you if :
You have strong analytical capacities and an ease to work with data.
You enjoy working with systems and technology, continuously learning.
You want to work in a collaborative team where your ideas are heard and valued.
RESPONSIBILITIES
Provides general data management support to the project team, sponsor and external vendors, as needed.
Supports Lead Data Manager in the areas of:
Data Review.
Data Reconciliation.
Discrepancy Management.
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.
User Maintenance.
Assisting with User Acceptance Testing.
Assisting with designing of database.
Assisting with creating data management plan (DMP), and other clinical data management related documentation.
Assisting in ensuring that data management documentation is complete and up-to-date in the trial master file (TMF).
Requirements
IDEAL PROFILE Education B.Sc. or related field; Experience 1 year of clinical data management experience in the pharmaceutical industry or in a CRO environment is considered an asset; Experience using an EDC system (ie. Medidata Rave, Medrio) is considered an important asset.
Knowledge and skills Skilled in use of computer technology, and ability to learn new applications; A general knowledge of CDASH/SDTM is considered an asset Highly organized and detail-oriented with effective project planning and time management skills; Strong verbal and written communication skills in English, French is an asset; Ability to work in a fast-paced environment with demonstrated agility to juggle and prioritize multiple competing demands; Excellent interpersonal, communication, problem solving and organizational skills with the ability to work both independently and in a team environment.
Understanding of the drug development process and of applicable regulations, including Good Clinical Practices, ICH Guidelines, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.
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:
Flexible work schedule Permanent full-time position Ongoing learning and development Work location Note that this opening is for a home-based position in Philippines. Attendance at some meetings outside of regular business hours (primarily in the evening) is required.
About Indero
A Global Clinical Leader In Dermatology and Rheumatology!
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 pr oviding 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 South Africa