Clinical Data Manager-Philippines

Description

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)