Senior Clinical Data Analyst - Single Sponsor (Remote)
New
South Africa, Poland, Hungary or UKFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- At least five years’ or preferably up to 8 years'
Requirements
- Bachelor’s Degree required, preferably in the scientific/healthcare field.
- Proven leadership experience.
- Good project management skills and a proven ability to multitask.
- At least five years’ or preferably up to 8 years' experience, in Data Management for the pharmaceutical/biotechnology industry.
- Understanding of the scope and focus of Phase I – IV clinical studies, and a proven ability to perform some of the core Data Management tasks and interact with vendors.
- 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.
- Strong English language written and verbal communication skills.
- Able to travel to meetings or training seminars on occasion.
- 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.
- RAVE experience is strongly preferred.
- Experience and understanding of the Oncology or CNS therapeutic area and with Phase III pivotal studies are desirable.
Responsibilities
- Lead a large clinical study or a series of related studies with minimum guidance.
- Represent Data Management on the CTWG for assigned studies.
- Provide mentoring and training to lower-level Data Management staff assigned to your 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.
- 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.
- Develop or lead the development of the Data Management Plan for a clinical study.
- 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.
- Perform database lock and freeze activities per company SOPs.
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