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.
• Develops or lead the development of the Data Management Plan for a clinical study.
• Reviews and provides 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.

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.

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