Job Description
Responsibilities: - Leads a large clinical study or a series of related studies with minimal guidance.
- Represents Data Management at study management team meetings.
- Provides mentoring and training to lower-level Data Management staff assigned to his/her studies. Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies; build effective relationships with CRO / vendor counterparts.
- Reviews protocols for appropriate data capture including electronic Case Report Form (eCRF) design.
- Performs a thoroughly detailed review of eCRF data requirements and create one if need be.
- Interacts with CRAs, programmers, study operations lead and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.
- Leads the development of data edit check specifications and data listings.
- Coordinates the design and testing of Electronic Data Capture (EDC) systems according to company processes.
- Resolves EDC system issues with team members.
- Develop or lead the development of the Data Management Plan for a clinical study.
- Reviews and provide feedback to the clinical team on other study documents Statistical analysis plans and vendor specifications.
- Provides training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed.
- Performs reconciliation of data from external data sources against the clinical database.
- Performs Serious Adverse Event reconciliation activities according to SOPs and guidelines.
- Leads database upgrades/migrations including performing User Acceptance Testing.
- Performs database lock and freeze activities per company SOPs.
- Performs miscellaneous duties as assigned.
Requirements: - Bachelor's Degree required in the scientific/healthcare field with 9 years of experience.
- Master's degree with 7 years of experience or PhD with 4 years of experience, preferred.
- Must have good project management skills and a proven ability to multitask.
- Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors. Possesses strong English language written and verbal communication skills.
- Experience in working with oncology studies.
- Able to travel to off-site meetings or training seminars as needed.
- Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications.
- Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems is desirable.
Katalyst HealthCares and Life Sciences
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