Manager, Records Management
New
Mexico, Brazil, Argentina, Colombia, Chile, and PeruFull-TimeManager
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Languages
- English
- Experience
- A minimum of 8 years of related experience, including a minimum of 2 years in a leadership capacity
- Required Skills
- Microsoft OfficeProcess improvement
Requirements
- Bachelor’s degree or equivalent international equivalent.
- Minimum of 8 years of related experience.
- Minimum of 2 years in a leadership capacity.
- Professional working proficiency in English.
- Experience with eTMF systems and vendors.
- Track record of implementing process and standardization for clinical trials.
- Working knowledge of FDA & ICH/GCP regulations and guidelines.
- Fluency in Microsoft Office (Outlook, Word, Excel, PowerPoint).
- Excellent organizational and time management skills.
- Strong interpersonal, verbal, and written communication skills.
Responsibilities
- Oversee staff performing TMF-related activities including document quality review and processing.
- Review study TMF Plan and TMF Document Index for alignment with study requirements.
- Complete periodic and random quality and completeness checks of team output.
- Review TMF metrics via system reports and identify process or staff performance challenges.
- Support audits and inspections, and address TMF-related escalations.
- Perform 1:1 meetings, provide performance reviews, and identify staff development needs.
- Train staff on responsibilities, processes, and procedures.
- Collaborate on drafting SOPs, forms, and work instructions.
- Support Business Development activities such as proposal responses and bid defense meetings.
View Full Description & ApplyYou'll be redirected to the employer's site
