Manager, Records Management
New
P
Precision Medicine GroupClinical Trial Services
We’re expanding across Mexico, Brazil, Argentina, Colombia, Chile, and PeruFull-TimeManager
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- 8 years of related experience, including a minimum of 2 years in a leadership capacity
- Required Skills
- Microsoft OfficeTeam managementProcess improvement
Requirements
- Bachelor’s degree or international equivalent.
- Minimum 8 years of related experience.
- Minimum 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 tracking and reporting clinical trials.
- Working knowledge of FDA & ICH/GCP regulations and guidelines.
- Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).
- Strong organizational and time management skills.
- Excellent problem-solving and interpersonal skills.
Responsibilities
- Oversee staff performing TMF-related activities including document quality review and processing.
- Review study TMF Plan and Document Index to ensure alignment with study-specific requirements.
- Perform periodic and random quality and completeness checks of work performed by team members.
- Support audits and inspections, attending meetings as required.
- Provide team support, training, performance management, and back-up.
- Collaborate with leadership to ensure process improvement and efficiency.
- Ensure team members have assigned studies or tasks for appropriate allocation to billable work.
- Engage with cross-functional stakeholders and sponsors to resolve TMF issues.
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