Senior Clinical Data Manager - FSP
Parexel · Mexico
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel is hiring a Senior Clinical Data Manager in Mexico or Argentina.
The Senior Clinical Data Manager will be responsible for performing Data Management activities that support client’s commercial and development projects worldwide. He/she will participate as an active member of a multi-disciplinary team to plan, lead and execute the Data Management tasks required for phase 1-4 studies. The Senior Clinical Data Manager has a broad, fundamental knowledge of the data management process and is able to perform most required tasks with minimal guidance.
Essential Functions
- Be able to lead a large clinical study or a series of related studies with minimal guidance
- Represents Data Management on the CTWG for assigned studies
- Provide 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
- Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design.
- Be able to perform a thoroughly detailed review of eCRF data requirements.
- Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.
- Lead the development of data edit check specifications and data listings
- Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members
- Develop or lead the development of the Data Management Plan for a clinical study.
- Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications
- May provide training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed
- Perform reconciliation of header data from external data sources against the clinical database
- Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines
- Lead database upgrades/migrations including performing User Acceptance Testing
- Be able to maintain study workbooks and data management files
- Perform database lock and freeze activities per company SOPs
- Participate in regular team meetings and provide input when appropriate
- Provide input into the development of data management SOPs, Work Instructions, and process documents; take a leadership role in the development of assigned documents
- Contribute to a professional working environment including the application of client’s Code of Business Conduct and Ethics
- Assist with the training of new employees and/or contractors
Required Knowledge, Skills, and Abilities
- At least 8 years’ experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment, including study lead experience
- Has good project management skills and a proven ability to multitask
- Understands the scope and focus of Phase 1-4 clinical studies, and has a proven ability to perform most of the core Data Management tasks and interact with vendors.
- Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidances, 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 and understanding of the Oncology or CNS therapeutic area, and with Phase III pivotal studies are preferred.
- 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
Required/Preferred Education and Licenses
- BA/BS, preferably in the scientific/healthcare field.