Clinical Data Management Lead
1 week ago
The Clinical Data Management Lead is responsible for the leadership and overall strategic management of clinical data management activities. This individual is responsible for data management decisions, including quality, timelines, and resources related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations, and company Standard Operating Procedures (SOPs).
Key Responsibilities:
- Responsible for the overall success of clinical data management activities.
- Maintains an overview of clinical program status and issues, and proactively communicates progress, risks, issues, or changes that may impact quality, timelines, and/or budget.
- Reviews plans and provides clinical data management expertise during protocol design, study start-up, and conduct phases of studies.
- Ensures consistency within the program and development of standard methodologies within clinical data management.
- Ensures use of standards for data collection and cleaning.
- Ensures quality results, implements timelines, and is accountable for ensuring consistency of process and approaches across clinical study results.
- Leads all aspects of program-level result timelines, ensuring proper resources are in place and supervising overlapping deliverables.
- Oversees clinical data management study budgets within a program, ensuring review of initial study budget and handling the budget through the lifecycle of the program by communicating changes as appropriate.
Requirements:
- Bachelor's degree in Mathematics, Science, or a related field.
- Minimum of 12 years of clinical data management experience in biotechnology, pharmaceutical, or health-related industry.
About Pharmiweb:
Pharmiweb is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.
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