Manager, Records Management – LATAM

ManagerManagerFull TimeRemoteLeadTeam 1,001-5,000H1B No SponsorCompany SiteLinkedIn

Location

Brazil

Posted

4 days ago

Salary

0

Seniority

Lead

Bachelor Degree8 yrs expEnglishGoogle Cloud Platform

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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