Manager, Records Management – LATAM
Location
Brazil
Posted
4 days ago
Salary
0
Seniority
Lead
Job Description
Manager, Records Management – LATAM
Precision For Medicine
• Oversee staff performing TMF-related activities which may include document quality review and processing, TMF quality review, and/or study-level engagement to ensure filing of essential clinical study documents • Perform review of the study TMF Plan and TMF Document Index to ensure alignment of staff activities with study-specific requirements • Assist with addressing any cross-functional questions related to TMF management and alignment with study-specific documentation • Ensure proper execution of role-specific activities and oversee the quality of TMF support provided by Documents Specialists, Quality Review Specialists and/or TMF Leads • Complete periodic and random quality and completeness checks of work performed by team members • Review TMF metrics via system reports and dashboards and identifies process and staff performance challenges • Ensure any TMF-related documentation is filed in the eTMF when required • Identify systemic issues with quality and completeness of study-specific TMFs, recommend solutions and support team members in implementation of mitigation strategies • Support staff in communications with project teams related to issues and noncompliance with TMF-related standards • Work with staff to proactively anticipate challenges to TMF compliance and identify early signals of risk • Develop and implement plans to increase compliance and follows-up on non-compliance • Support audits and inspections and attend audit/inspection meetings when needed • Address escalations related to TMF issues and lead implementation of solutions and mitigation strategies • Support team members on internal and external study calls if issues and escalations emerge • Support Business Development activities, such as Proposal responses or participation at Bid Defense meetings related to TMF processes • Monitor team member assignments on studies in line with budgets and oversee the reporting of potential out of scope activities to PM, as needed • Oversee staff performing job responsibilities in Sponsor eTMF Systems and actively listen to deliver insightful solutions for challenges faced by team members • Engage with cross-functional stakeholders and Sponsors to eliminate emerging issues with completeness or quality
Job Requirements
- Bachelor’s degree (or its international equivalent)
- A minimum of 8 years of related experience, including a minimum of 2 years in a leadership capacity Or equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to perform the job
- 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
- Established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel and PowerPoint)
- Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines
- Excellent verbal and written communication skills
- Excellent problem-solving skills
- Demonstrates solid interpersonal skills
- Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment
- Communicates both verbally and in written form in an efficient and professional manner
- Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, possess good interpersonal skills and maintain positive interactions with internal and external stakeholders
- Demonstrates values and a work ethic consistent with Precision Values and Company Principles.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
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