Sr Clinical Data Manager
Sr Clinical Data Manager
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Salary Not Disclosed
1 Vacancy
Job Description
Roles & Responsibilities:
- Bachelors degree in science related field.
- Minimum of 9 years pharmaceutical industry data management experience.
- Working knowledge of Good Clinical Practices Good Manufacturing Practices Clinical research Clinical trial process and related regulatory requirements and terminology.
- Working knowledge of Clinical database applications such as EDC and CTMS.
- Applicable knowledge working with other clinical databases such as SAS
- Experience with working on Phase IIV study trials within the pharmaceutical industry.
- Working knowledge of industry standards such as the ICH guidelines CDISC data structures and FDA guidelines.
- Excellent organizational skills time management and ability to meet established deadlines.
- Excellent verbal and written skills good organizational interpersonal and team skills.
- Excellent multitasking skills.
- Ability to work effectively across a matrix organization.
- Ability to work independently and collaboratively.
- Responsible for data management documentation including but not limited to data management plan (DMP) CRF eCRF design edit check specifications data issue logs and data review plans and ensures all documents follow study design and regulatory requirements.
- Review clinical trial data specifications including eCRF design user requirements edit rules/checks query logic and data validations. Review queries and tracking status.
- Be accountable for EDC database (DB) specification process EDC user guides and ensure clinical data within EDC is in good quality Review User Acceptance Testing (UAT) summary report.
- Responsible data transfers between vendors and/or Sponsor.
- Responsible for reconciliation of external data.
Employment Type
Full Time
