The posting
The Clinical Data Manager, will participate in various clinical data management activities required to ensure that data captured in a few clinical trials undertaken, or managed by Innovaderm, 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 Innovaderm’s commitment to sponsor’s requirements and timelines.
This role will be perfect for you if:
- You enjoy working with a mid-sized CRO where you can build professional relationships with your colleagues at all levels
- You bring previous experience in managing data management
- Dermatology is a therapeutic area you enjoy or want to learn more about
RESPONSIBILITIES
- Provides general data management support to the project team, sponsor and external vendors, as needed.
- Is responsible for the development of electronic case report form (eCRF) specifications (including data capture screens and edit check specifications) needed to build a study-specific clinical database/electronic data capture (EDC) system.
- Is responsible for the programming and ongoing maintenance of the clinical database.
- Is responsible for the validation and testing of the clinical database (e.g. User Acceptance Testing).
- Is responsible for the development of eCRF completion guidelines and other training material required to train site users and monitors.
- Conducts training for site users/monitors on the clinical database.
- Develops data transfer agreements and specifications with vendors providing external data (e.g. laboratory results).
- Conducts reconciliation between external data and data in the EDC system to ensure consistency, including reconciliation with sponsor safety databases for adverse events/serious adverse events data (if needed).
- Provides support to study team in the development of external systems capturing clinical data, e.g. ePRO or IWRS, and ensuring that any data transfer requirements between these systems and EDC are documented and tested appropriately.
- Is responsible for the development of the data management plan (DMP), and other clinical data management related documentation.
- Is responsible for ongoing data review/cleaning during study conduct and also during preparation for database lock/close.
- Codes medical terms in the clinical database, as required.
- Generates data listings and reports needed for data review by the project manager (or other study team members) in preparation for database close/lock.
- Monitors study status (e.g. enrollment, CRFs monitored/approved, etc.) on an ongoing basis and provides data status reports to the project team, as needed.
- Ensures that data management documentation is complete and up-to-date in the trial master file (TMF).
- Activates/de-activates new users in the clinical database in response to requests from the project manager and maintains records of such requests.
- Responds to users requiring assistance with the EDC system.
- Is responsible for archiving of the clinical database and related documents.
- Participates in the definition, writing and updating of data management SOPs
- Mentors and trains a Clinical Data Coordinator.
- For any studies where any of the above activities have been outsourced to an external service provider:
- Oversees/manages the vendor to ensure that timelines and deliverables meet with sponsor and protocol requirements
- Ensures that their work is done in accordance with effective work orders and Innovaderm SOPs (if applicable).
Requirements
Education
- B.Sc. or in a related field of study;
- M. Sc. Or in a related field of study is an asset;
Experience
- Between 5 to 10 years of clinical data management experience in clinical research in the biotechnology, pharmaceutical, or contractual research organization (CRO) industry;
- Understanding of the drug development process and of applicable regulations, including Good Clinical Practices, ICH Guidelines;
- Extensive experience working with EDC systems, and/or database structures, including demonstrated skills in database programming;
Knowledge and skills
- Good understanding of CDISC SDTM/CDASH standards;
- Highly organized and detail-oriented with effective project planning and time management skills.
- Strong verbal and written communication skills in English;
- Excellent problem solving abilities;
- Ability to work in a fast-paced environment with demonstrated agility to juggle and prioritize multiple competing demands;
- Knowledge of MedDRA and WHODrug dictionaries.
- Good knowledge of good clinical practices, 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 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 Philippines.
