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Overview
Exp. required: Mid-Level (3-5 yrs)
Job Description
- Oversee the day-to-day operations of study-specific TMF management
- Review and approve TMF Plans
- Participate in Quality Control of documents
- Facilitate review and submission of TMF records
- Maintain study team compliance to policies and regulatory requirements
- Act as TMF business process SME
- Support management of TMF-related activities
- Assist in monitoring and tracking clinical trial progress
- Stay abreast of current regulations
- Prepare meeting agendas and minutes
Job Requirements
- Bachelor’s Degree preferred
- 5+ years’ experience managing or supporting TMF activities
- 1+ years of experience serving as eTMF Administrator
- Experience in managing TMF documents during regulatory inspections
- Working knowledge of various guidelines and regulations
- Ability to multi-task and manage projects
- Strong critical thinking skills
- Proactive and self-motivated
- Ability to work independently with minimal supervision
Benefits
- Opportunities to contribute to developing potential medicines
- Recognition and rewards for contributions
Company Description: Cytokinetics is a biopharmaceutical company developing therapies for debilitating diseases.
Founder: Not Found
Year Founded: 1998
Headquarter: South San Francisco, California
Ownership: Public
Number of Employees: 201-500 employees
Investment Raised: Not Found
Global Ranking: 16064
Email: info@cytokinetics.com
Industry
Biotechnology Research
Specialties
Heart Failure
Amyotrophic Lateral Sclerosis
Hypertrophic Cardiomyopathy