Manager, Records Management – LATAM

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $75M Private Equity Round on 2015-12

Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• 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

🎯 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