The Senior Clinical Data Manager will lead and manage multiple 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.
More specifically, the Senior 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.
-
Be able to manage three to four concurrent studies independently, with minimal supervision.
-
Be able to take decision with minimal support from manager.
-
Attend meeting with sponsor and answers Data Management related question.
-
Provides input for timelines and monitor 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 provides data status reports to the project team, as needed.
-
Ensure 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.
-
Participate in the definition, writing and updating of data management Work Instructions
-
Mentor and train Clinical Data Coordinators, as needed.
-
Provide basic support to less experienced Clinical Data Managers, as needed.
-
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
-
5 to 8 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.
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.
-
Good knowledge of MS Excel.
-
Knowledge of SAS or similar, an asset;
-
Excellent problem solving abilities;
-
Ability to work in a fast-paced environment with demonstrated agility to organize and prioritize multiple competing demands.
-
Knowledge of MedDRA and WHODrug dictionaries.
Brand name:
Indero
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 India. Attendance at some meetings outside of regular business hours (primarily in the evening) is required.
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 India.
