Precision for Medicine
Manager of Clinical Systems — Records Management (LATAM) About the Role As part of an exciting expansion across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, we are looking for an experienced and driven Manager of Records Management to join our growing LATAM team. This is a pivotal leadership role responsible for building and overseeing a high-performing team of Documents Specialists, Quality Review Specialists, and TMF Leads who ensure the quality and compliance of study-specific Trial Master Files (TMF) across a dynamic portfolio of clinical programs. In this role, you will provide hands-on leadership and strategic oversight to ensure that essential clinical study documents are filed in accordance with Good Clinical Practice (GCP), relevant regulatory requirements, and established Standard Operating Procedures (SOPs). You will also partner closely with cross-functional leadership to drive continuous process improvement and operational efficiency across the Records Management function and broader Clinical Solutions team. This is a remote-eligible position offering the opportunity to make a meaningful impact on clinical trial operations at a regional scale. Responsibilities TMF Oversight & Quality (60%) Oversee staff performing TMF-related activities, including document quality review and processing, TMF quality review, and study-level engagement to ensure filing of essential clinical study documents Review the study TMF Plan and TMF Document Index to ensure alignment of staff activities with study-specific requirements Assist in addressing 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; identify process and staff performance challenges and take corrective action as needed Ensure all required TMF-related documentation is filed accurately in the eTMF system Identify systemic issues with quality and completeness of study-specific TMFs, recommend solutions, and support team members in implementing mitigation strategies Support staff in communications with project teams related to issues and noncompliance with TMF-related standards Proactively anticipate challenges to TMF compliance and identify early risk signals; develop and implement plans to increase compliance and follow up on non-compliance Support audits and inspections, attending audit/inspection meetings as required Address escalations related to TMF issues and lead the implementation of solutions and mitigation strategies Support team members on internal and external study calls when issues or escalations arise Contribute to Business Development activities, including proposal responses and participation in Bid Defense meetings related to TMF processes Monitor team member assignments on studies in alignment with budgets; oversee reporting of potential out-of-scope activities to Project Management as needed Oversee staff performing responsibilities in Sponsor eTMF systems and deliver insightful solutions for challenges faced by team members Engage with cross-functional stakeholders and Sponsors to proactively eliminate emerging issues with TMF completeness or quality Staff Management (30%) Conduct weekly or biweekly one-on-one meetings with team members to discuss workload, performance, responsibilities, and professional development Ensure effective prioritization of work and team members' ability to meet expected timelines while delivering quality outcomes Perform annual and semi-annual performance reviews, providing clear and constructive feedback to promote performance excellence Identify staff development and training needs to ensure consistently high-level performance across the team Train staff in the execution of their responsibilities and in the adoption of ongoing and new processes and procedures Review applications, interview candidates, and make informed hiring decisions for new team members Ensure the team is fully staffed and capable of supporting all clinical documents management requirements within the TMF Execute financial oversight and ensure team members have assigned studies or tasks to support appropriate allocation to billable work and full utilization Process Improvement (10%) Support process improvement initiatives and adoption of best practices across Clinical Solutions Collaborate in drafting SOPs, Forms, and Work Instructions as assigned by leadership Communicate emerging trends and recommend process improvements and targeted training for the Records Management team Identify gaps in knowledge, processes, or expectations among external project team members and recommend re-training, communication, and engagement strategies Provide subject matter expertise and support to internal stakeholders and external partners in promoting TMF best practices Requirements Education & Experience Bachelor's degree or international equivalent
North Island - Taranaki New Plymouth
Surgical Referral & Booking Administrator Te Whatu Ora Taranaki | Permanent, Full Time | 1.0 FTE (80 hours per fortnight) About the Role Te Whatu Ora Taranaki is seeking a dedicated and detail-oriented Surgical Referral & Booking Administrator to join our Surgical Booking Office at Taranaki Base Hospital. This is a permanent, full-time opportunity for someone who thrives in a fast-paced healthcare environment and is passionate about making a meaningful difference in patients' lives. In this role, you will be an integral part of the administrative backbone supporting surgical services across the hospital. You will work closely with surgeons, registrars, nurses, and wider hospital staff to ensure that patients are referred, scheduled, and supported efficiently and with care throughout their surgical journey. Responsibilities As a Surgical Referral & Booking Administrator, your day-to-day responsibilities will include: Referrals management — receiving, processing, and triaging surgical referrals in accordance with clinical guidelines and organisational protocols Clinic and theatre scheduling — coordinating and maintaining surgical bookings for outpatient clinics and operating theatre lists to optimise patient flow and minimise wait times Maintaining close and collaborative working relationships with Consultants, Registrars, and clinical teams to ensure accurate and timely scheduling Communicating with patients and their families to confirm appointments, provide information, and offer support throughout the booking process Accurately entering, updating, and managing patient data using hospital administration systems, ensuring records are current and complete Monitoring and following up on waitlist management in alignment with health targets and patient need Handling a variety of administrative tasks including correspondence, documentation, and reporting as required by the team Contributing to a positive, efficient team environment and supporting continuous improvement initiatives within the Surgical Booking Office About the Team Our Surgical Referral & Booking team plays a crucial role in ensuring patients receive the surgical care they need in a timely manner. Working alongside healthcare professionals in a supportive and dynamic environment, the team's attention to detail and organisational excellence directly contributes to better patient outcomes and the smooth operation of hospital services. No two days are the same — this role offers genuine variety, meaningful challenge, and the satisfaction of knowing your work makes a real difference to people's lives. Requirements We are looking for a motivated individual who aligns with our values and is committed to delivering exceptional service to our patients and community. The ideal candidate will bring: Previous experience in health administration or a similar administrative role (desirable) Working knowledge of Webpas/IBA and Concerto patient management systems (desirable) Strong organisational and time management skills, with the ability to manage competing priorities effectively Excellent communication skills, both written and verbal, and the ability to liaise professionally with clinical staff and patients High attention to detail and accuracy in data entry and record management A patient-centred approach and genuine commitment to supporting people through their healthcare journey The ability to work both independently and collaboratively as part of a team Proficiency in general computer and office software applications A flexible, adaptable attitude in a constantly evolving health environment About Taranaki Taranaki is a place like no other. Home to the iconic Mt Taranaki, more than 12 world-class surf breaks, and some of New Zealand's most spectacular natural landscapes, Taranaki offers an exceptional quality of life. Whether you're drawn to skiing, surfing, coastal walks, mountain trails, or a thriving café and arts culture, this region has something for everyone. It is a vibrant, welcoming community where you can genuinely build a life as well as a career. About Te Whatu Ora | Health New Zealand Health New Zealand | Te Whatu Ora is dedicated to ensuring excellent healthcare for all New Zealanders. We are firmly grounded in the principles of Te Tiriti o Waitangi and are committed to building a health system that is equitable, inclusive, and responsive to the needs of all communities. We actively welcome applications from our diverse Māori, Pacific, disabled, and rainbow communities, and embrace a workforce that reflects the people we serve. How to Apply If you share our vision and values and are ready to contribute to the health and
Precision Medicine Group
Manager of Clinical Systems (Records Management) — LATAM About the Role As part of an exciting expansion across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, we are seeking a talented and experienced Manager of Records Management to build and lead our growing Clinical Systems team in the LATAM region. This is a high-impact leadership role at the intersection of clinical operations, quality management, and team development — ideal for a seasoned professional ready to shape the future of Trial Master File (TMF) management across a dynamic and growing portfolio. In this role, you will oversee a team of Documents Specialists, Quality Review Specialists, and TMF Leads, ensuring the quality and compliance of study-specific Trial Master Files across a broad range of clinical programs. You will serve as a subject matter expert, a people leader, and a strategic partner to cross-functional stakeholders — all while driving continuous process improvement and operational excellence within Clinical Solutions. Responsibilities TMF Oversight & Quality (60%) Oversee staff performing TMF-related activities, including document quality review and processing, TMF quality reviews, and study-level engagement to ensure proper filing of essential clinical study documents Review study TMF Plans and TMF Document Indexes to confirm alignment of staff activities with study-specific requirements Assist in addressing cross-functional questions related to TMF management and study-specific documentation alignment Ensure proper execution of role-specific activities and oversee the quality of TMF support delivered by Documents Specialists, Quality Review Specialists, and TMF Leads Complete periodic and random quality and completeness checks of work performed by team members Review TMF metrics via system reports and dashboards, identifying process and staff performance challenges Ensure all required TMF-related documentation is filed in the eTMF in a timely and compliant manner Identify systemic issues with quality and completeness of study-specific TMFs, recommend solutions, and support team members in implementing mitigation strategies Support staff in communications with project teams regarding TMF-related issues and noncompliance with established standards Work proactively with staff to anticipate challenges to TMF compliance and identify early signals of risk Develop and implement compliance improvement plans and follow up on outstanding noncompliance issues Support audits and inspections and attend audit/inspection meetings as needed Address escalations related to TMF issues and lead the implementation of solutions and mitigation strategies Support team members on internal and external study calls when issues or escalations arise Contribute to Business Development activities, including proposal responses and participation in Bid Defense meetings related to TMF processes Monitor team member study assignments in line with budgets and oversee reporting of potential out-of-scope activities to the Project Manager as needed Oversee staff performing responsibilities within Sponsor eTMF Systems, providing insightful solutions to challenges they face Engage with cross-functional stakeholders and Sponsors to proactively resolve emerging issues with TMF completeness or quality Staff Management (30%) Conduct weekly or biweekly one-on-one meetings with direct reports to discuss workload, priorities, performance, and professional development Ensure effective prioritization of work and the team's consistent ability to meet expected timelines with high-quality deliverables Complete annual and semi-annual performance reviews, providing clear, direct, and constructive feedback to promote performance excellence Identify staff development and training needs to maintain a high level of team performance Train team members in the performance of their responsibilities and in the adoption of new and updated processes and procedures Review applications, conduct interviews, and make hiring decisions for new team members Ensure the team remains fully staffed and capable of supporting all clinical document management requirements Execute financial oversight, ensuring team members have assigned studies or tasks for appropriate allocation to billable work and full utilization Process Improvement (10%) Support process improvement initiatives and process adoption across Clinical Solutions Collaborate on drafting SOPs, Forms, and Work Instructions as assigned by leadership Communicate observed trends and suggest process improvements and targeted training opportunities for the Records Management team Identify gaps in knowledge, process, or understanding among external project team members regarding TMF management expectations, and recommend retraining, communication strategies, or other forms of engagement Provide subject matter expertise and support to internal stakeholders and external partners in promoting TMF best practices Requirements Education & Experience Bachelor's degree or its international equivalent A minimum of 8 years of related experience