Description
The Clinical Data Manager will lead and manage clinical studies, ensuring that data 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.
As a Clinical Data Manager, you will ensure that data captured in multiple clinical trials undertaken or managed by Indero is collected, managed, and reported clearly, accurately and securely.
More specifically, the Clinical Data Manager 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.
- Be the data management liaison to the project team, sponsor and external vendors, as needed.
- Manage up to three studies, based on study complexity, with some support from manager.
- Attend meeting with sponsor and answers Data Management related question.
- Monitor timelines and scope of work to ensure timely and within budget completion of assigned tasks
- Be 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.
- Be responsible for or assist in the programming and ongoing maintenance of the clinical database.
- Be responsible for the validation and testing of the clinical database (e.g. User Acceptance Testing).
- Be responsible for the development of eCRF completion guidelines and other training material required to train site users and monitors.
- Conduct training for site users/monitors on the clinical database.
- Develop data transfer agreements and specifications with vendors providing external data (e.g. laboratory results).
- Conduct 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).
- Provide 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.
- Be responsible for the development of the data management plan (DMP), and other clinical data management related documentation.
- Be responsible for ongoing data review/cleaning during study conduct and also during preparation for database lock/close.
- Code 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.
- Monitor study status (e.g. enrollment, CRFs monitored/approved, etc.) on an ongoing basis and provide 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).
- Respond to users requiring assistance with the EDC system.
- Be responsible for archiving of the clinical database and related documents.
- Support the writing and updating of data management Work Instructions.
- Mentor and train a Clinical Data Coordinator on the specificities of their studies.
- For any studies where any of the above activities have been outsourced to an external service provider:
- Oversee/manage the vendor to ensure that timelines and deliverables meet with sponsor and protocol requirements
- Ensure that their work is done in accordance with effective work orders and Innovaderm SOPs (if applicable).
Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.
Requirements
Education
- B.Sc. or in a related field of study;
- M. Sc. Or in a related field of study is an asset;
Experience
- 3 to 5 years of clinical data management experience or at least 1 year of lead clinical data manager 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;
Knowledge and skills
- Demonstrated skills in database programming an asset.
- 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, French an asset;
- Excellent problem solving abilities;
- Knowledge of SAS or similar, an asset;
- Working knowledge of MS Excel;
- Ability to work in a fast-paced environment with demonstrated agility to organize 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 / work schedule :
- Home-based position
- Ongoing learning and development
About Indero
Indero is a contract research organization (CRO) specialized in dermatology and Rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.
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 India
Requires a bachelor's degree, 3–5 years of clinical data management experience or 1 year as a lead clinical data manager, EDC expertise, clinical research knowledge, and strong English communication skills.
Key Responsibilities
- managing studies
- developing databases
- reviewing data
Skills & Tools
Electronic Data Capture (EDC), SAS, Microsoft Excel, CDISC SDTM, CDISC CDASH, MedDRA, WHODrug, ePRO, IWRS, Trial Master File (TMF)
Job Details
- Category: Data and Analytics
- Seniority: Mid Level
- Commitment: Full Time
- Workplace: Remote — Pune, Maharashtra, India
- Languages: English
About Indero
A contract research organization specializing in dermatology and rheumatology clinical research. — Industry: Research and Development