Associate Director of TMF Operations & Clinical Operations Analytics

Role overview The Associate Director of TMF Operations & Clinical Operations Analytics at TGS leads a remote team dedicated to strengthening trial master file (TMF) operations and advancing analytics within clinical operations. This position focuses on upholding compliance, quality, and efficiency throughout clinical trial activities. Main responsibilities S…

Role overview TransPerfect is seeking an Associate Director, TMF Operations & Clinical Analytics to join the Clinical Science and Medical Affairs group. This fully remote role reports to the Clinical Operations Leadership Team. The focus is on providing strategic oversight for Trial Master File (TMF) operations, with an emphasis on improving process functionality, efficiency, scalability, and quality. Key responsibilities Direct the TMF support model, managing both processes and systems Oversee TMF vendor relationships and manage associated processes Act as the primary contact for all TMF-related activities Develop and implement global TMF standards, standard operating procedures (SOPs), and controlled documents in line with regulations and industry expectations Maintain inspection readiness and coordinate support for audits and regulatory inspections Provide expert input on clinical documents, particularly study plans Analyze and present TMF metrics and KPIs to leadership to demonstrate TMF health Lead updates and improvements to the TMF support model Negotiate TMF vendor budgets and manage operational expenditures Requirements Significant experience with TMF systems and processes Proven background in vendor management Thorough understanding of inspection readiness and audit support Ability to oversee reporting, metrics, KPIs, and analytics for Clinical Operations Strong collaboration skills with senior leaders and stakeholders to deliver meaningful reports that support performance measurement and continuous improvement Remote work This position is fully remote.

Role Overview Revolution Medicines is seeking a Clinical TMF Manager to join the Clinical Operations team in Redwood City, California. This role manages Trial Master File (TMF) processes for clinical trials, ensuring all documentation meets regulatory requirements and industry standards. What You Will Do Oversee TMF activities for ongoing and future clinical studies. Monitor TMF compliance with applicable regulations and internal guidelines. Work closely with cross-functional teams to maintain accurate and complete trial documentation. Support the success of clinical programs by ensuring timely and organized TMF management.

Join Revolution Medicines as an Associate Director of Clinical TMF Management, where you will lead a team focused on ensuring the highest quality in clinical trial master file (TMF) management. Your expertise in clinical operations will be crucial in enhancing our processes and compliance.

This remote role based in the United States allows for work from home, with some travel required as needed. Role overview The TMF Operations Lead at Praxis Precision Medicines is responsible for maintaining clinical trial documentation that is accurate, complete, and inspection-ready. Acting as the primary resource for Trial Master File (TMF) matters, this role supports study teams to uphold quality and compliance standards throughout clinical trials. Main responsibilities Act as the subject matter expert for TMF and collaborate closely with study teams. Oversee the setup and ongoing maintenance of the electronic TMF (eTMF), including conducting regular quality checks. Track TMF status and key milestones, sharing metrics and insights with team members.

Join Our Mission Revolutionizing Clinical Trials at Lindus Health. We are committed to accelerating the development of new treatments through innovative and efficient clinical trials. In a landscape where outdated practices lead to increased costs and delays, we are reshaping the future of drug development to ensure patients gain access to life-saving therapies more swiftly than ever.Our achievements speak volumes: Since March 2021, we've successfully facilitated over 100 clinical trials, involving tens of thousands of patients. Recently, we secured a $55 million Series B funding round from Balderton Capital, with additional support from Creandum, Firstminute, Seedcamp, and Visionaries. What You Can Expect When You Join UsAt Lindus Health, you will engage in:Impactful Work with a Purpose: Engage in transformative projects that directly enhance patient outcomes and demonstrate the real-world impact of your contributions.Dynamic Environment with Ownership: We value results and dedication, allowing you to take on significant responsibilities and influence the trajectory of our success.Collaborative Culture: Join a team of bright, motivated individuals in a relaxed environment where creativity thrives, and teamwork is celebrated.Are you ready to be part of this transformative journey? We would love to hear from you. About the RoleWe are seeking an experienced Associate Director of Clinical Operations to take on a pivotal leadership role, combining oversight of clinical portfolios with commercial management responsibilities. This position merges operational expertise with commercial insight, ensuring the success of clinical trials from both operational and business perspectives.In this role, you will manage 3-5 active trials while leading a team of 3-5 Project Leads and Project Associates. You will provide guidance on resourcing, timeline management, and strategic direction, while also managing commercial aspects within defined SOW parameters. Building and maintaining strong sponsor relationships is key, along with facilitating the transition of projects from Business Development to Clinical Operations, providing operational insights that enhance the sales process.As a subject matter expert in Clinical Operations and a vital contributor to our culture, you will influence our working practices...

Role Overview Acadia Pharmaceuticals is hiring an Associate Director of Clinical Operations. This position is based in either Princeton, New Jersey or San Diego, California. The Associate Director will guide key phases of clinical trials, focusing on high-quality execution and adherence to regulatory requirements. What You Will Do Lead and oversee essential stages of clinical trial operations Ensure all activities meet regulatory and company standards Promote effective collaboration across multiple teams Drive project timelines to support company objectives Take a hands-on approach to managing clinical operations

Join Revolution Medicines, Inc. as an Associate Director of Clinical Operations, where you will play a pivotal role in advancing the development of innovative therapies. This leadership position will involve overseeing clinical trial management, ensuring compliance with regulatory standards, and collaborating with cross-functional teams to drive project success.

Nuvalent seeks an Associate Director of Clinical Operations to join the team in Cambridge, MA or work remotely. This leadership role guides the execution of clinical trials, ensuring every step aligns with regulatory standards and internal protocols. The position partners with cross-functional teams to develop and deliver on clinical strategies, overseeing studies from planning through closeout. What you will do Direct clinical trial operations for multiple concurrent studies Maintain compliance with all regulatory requirements and company procedures Work closely with colleagues across departments to create and implement clinical strategies Supervise all aspects of study management, from initiation to completion Oversee budgets, timelines, and resource planning for clinical programs Mentor and guide junior staff within clinical operations Requirements Significant experience in clinical operations and project management Background working in pharmaceutical or biotechnology organizations Demonstrated ability to manage budgets and timelines Experience mentoring or managing team members

We are seeking an experienced and dynamic Associate Director of Clinical Operations to join our team at Revolution Medicines. In this pivotal role, you will lead the planning, execution, and management of clinical trials, ensuring alignment with regulatory guidelines and company objectives. You will work closely with cross-functional teams to deliver innovative therapies to patients.

Join Our Mission to Safeguard Humanity!Vaxcyte is at the forefront of clinical-stage vaccine innovation, dedicated to developing high-fidelity vaccines aimed at protecting humanity from the serious and costly implications of bacterial diseases. Our commitment to eradicating or treating infections such as invasive pneumococcal disease, Group A Strep, and Shigella exemplifies our mission. With a clear and well-defined path to success, Vaxcyte is poised to make a significant impact. Our Approach: At Vaxcyte, what we do is as crucial as how we do it. Our collaboration is anchored in four enduring core values: *Rethink Convention: We infuse creativity and diverse thinking into every aspect of our work to continuously innovate how vaccines are delivered. *Aim High: We embrace our bold collective goal to courageously develop the most complex biologics ever attempted to safeguard humanity. *Lead with Heart: Every individual at Vaxcyte leads with a kindness-first, inclusive approach that fosters collaboration and vigorous debate to advance our business objectives. *Model Excellence: The scale of our challenge necessitates a shared commitment to integrity, accountability, equality, and transparency in communication and decision-making.Position Overview:The Associate Director of Quality Control Operations is a pivotal executive role within our global vaccine organization. This position is responsible for implementing Vaxcyte's analytical strategies at our Contract Development and Manufacturing Organizations (CDMOs) and Contract Research Organizations (CROs). Acting as the primary liaison for our CDMOs and CROs, you will ensure the delivery of high-quality, accurate, and compliant testing and analytical services. Collaborating closely with the analytical technical lead and various functions—including Analytics, Process Development, Manufacturing Science, Quality Assurance, and Regulatory Affairs—you will provide leadership and oversight for the execution of analytical strategies supporting analytical readiness and deliverables. You will be accountable for ensuring timely and compliant testing and release at our CDMO and CRO, facilitating a secure and uninterrupted supply of Vaxcyte’s groundbreaking therapies.

Join 4D Molecular Therapeutics as an Associate Director of Clinical Operations and play a pivotal role in leading innovative clinical trials that pave the way for groundbreaking therapeutic approaches. This position is fully remote, allowing you to collaborate with a dynamic team dedicated to advancing gene therapy solutions.

Definium Therapeutics, previously known as Mind Medicine, is a pioneering biopharmaceutical company in the clinical stage, focused on developing innovative product candidates aimed at addressing brain health disorders. Our vision is to lead globally in creating and delivering treatments that enhance patient outcomes. We are actively building a pipeline of groundbreaking product candidates that target neurotransmitter pathways crucial for brain health, encompassing both acute perceptual effects and non-perceptual modalities.Founded in 2019, we are on a trajectory of rapid expansion, continuously enhancing our global presence. We are in search of dynamic, high-impact individuals across various clinical, technical, and business operational domains to bolster our team of intelligent, patient-centered professionals.The Associate Director of Clinical Operations is responsible for overseeing trial-level operations within the organization. This role requires operational expertise to ensure the successful cross-functional delivery of assigned global clinical trials, adhering to agreed timelines and budgets while complying with all relevant SOPs and regulatory standards. The ADCO will oversee external service providers, manage the planning and execution of both internally and externally managed trials, from the initial protocol synopsis to the availability of the Clinical Study Report (CSR) and appropriate trial result disclosures.The ADCO leads the cross-functional Trial Team (CTT), engaging with all team members to construct the trial operational plan, and is jointly responsible with the Study Clinician and Clinical Scientist for managing external service provider contracts and budgets, ensuring alignment with organizational goals. This role provides operational leadership for trial execution, defines risk mitigation strategies, and ensures their implementation.Key Responsibilities:Lead the cross-functional Trial Team (CTT), monitoring project deliverables and timelines. Proactively manage to ensure milestones are achieved, identifying risks and implementing mitigation strategies.Ensure the trial is delivered within the agreed/projected budget. Manage trial budget accurately, including updates for scope changes and reconciliation of trial costs. Oversee trial-level contract management, including review and approval of contracts and change orders to ensure compliance with service delivery.Provide leadership for trial implementation, driving feasibility assessments and ensuring all operational aspects align with strategic objectives.

Oruka Therapeutics is developing biologics designed to change the treatment landscape for chronic skin conditions such as plaque psoriasis. The company focuses on long-lasting relief for patients, aiming for outcomes like disease clearance with infrequent dosing. Their pipeline includes proprietary antibodies created by Paragon Therapeutics, targeting the underlying causes of dermatologic and inflammatory diseases. More details about their work can be found at www.orukatx.com. Role overview The Associate Director of Clinical Operations will manage the setup and execution of clinical trials, supporting the Director of Clinical Operations within a specific therapeutic area. This position oversees multiple studies, combining strategic planning with day-to-day operational involvement to keep clinical programs on track and within budget. Responsibilities include handling operational details, anticipating challenges, and implementing solutions to ensure trial progress. The role requires someone who can move between leadership and hands-on work, maintaining a player/coach mindset throughout. What you will do Oversee all phases of clinical trial setup and execution across several studies Support the Director of Clinical Operations in a designated therapeutic area Balance strategic planning with direct, hands-on involvement in daily operations Identify and resolve operational challenges to maintain study timelines and budgets Requirements Demonstrated integrity and sound judgment in clinical operations Ability to shift between high-level oversight and direct involvement as needed Strong commitment to study goals and a collaborative approach Adaptability and resourcefulness in a biotech setting This hybrid role is based in Waltham, Massachusetts, with an expectation of three days onsite each week. The team values learning, growth, and a positive, inclusive culture.

Role Overview:The Director of Clinical Operations plays a pivotal role in ensuring that clinical stage programs meet both strategic and operational objectives in compliance with set timelines, budgets, and quality standards. This leadership position is vital in guiding the Clinical Operations team, shaping clinical program strategies, and fostering collaboration and transparency across multiple functions. The Director will work closely with both internal stakeholders and external partners to facilitate high-quality clinical trial execution within the dynamic landscape of a small-to-midsize biotech organization.Key Responsibilities:Program Strategy & Leadership (35%)Formulate and implement clinical program strategies that are aligned with corporate objectives. Lead the Clinical Operations team to optimize the allocation of resources across various programs.Clinical Trial Oversight (25%)Ensure that clinical trials are meticulously defined, planned, and executed in accordance with GCP, ICH, and FDA regulations. Monitor study timelines, budgets, and quality metrics to drive operational excellence.Regulatory & Documentation Support (15%)Assist in drafting key regulatory documents, ensuring that clinical program outputs meet submission requirements and regulatory standards.Vendor & CRO Management (15%)Oversee and manage Contract Research Organizations (CROs), vendors, and external partners to ensure that performance, deliverables, and financial accountability align with expectations.Team Development & Collaboration (10%)Cultivate a collaborative environment within Clinical Operations and exemplify leadership values. Encourage transparent communication, accountability, and operational discipline across the department.Other duties as assigned.

Iterative Health is at the forefront of healthcare technology and services, driving the evolution of clinical research to enhance patient outcomes. Our Site Network features over 70 premier clinical research sites across both the US and Europe, facilitating the rapid development of innovative gastrointestinal (GI) and hepatology therapies. We are dedicated to the success and expansion of our partner sites through the provision of tech-enabled services. By merging extensive clinical trial expertise with state-of-the-art AI technology, we empower research teams and study sponsors to broaden and accelerate access to transformative therapeutics for patients in need.About the RoleWe are on the lookout for a dynamic and driven Director of Operational Finance & Analytics to become an integral part of our expanding team. In this pivotal role, you will collaborate closely with executive leadership, finance, and operational teams to oversee the operational finance aspects of our growing network of research sites and enhance the company’s enterprise analytics capabilities, ensuring precision, consistency, and governance of critical metrics for a reliable single source of truth.Your contributions will be vital in constructing and scaling our Enterprise Data Warehouse (EDW) and executing Adaptive Insights, utilizing these essential systems to provide dependable reporting and forecasting that supports operational decision-making. This hands-on leadership position offers a unique opportunity to make a significant impact as the company evolves.

Role Overview Karius, Inc. is hiring a Director of Clinical Operations to strengthen clinical processes and uphold high standards across services. This leadership role calls for a strategic approach and deep experience in clinical operations. The Director will focus on refining workflows and supporting improved patient outcomes. Location This position is based in Redwood City, CA with a hybrid schedule, or can be performed remotely within the United States.

Sylvan Health seeks a Director of Clinical Operations to advance the integration of nutrition into both primary and specialty care. This is a fully remote position based in Oregon. The Director will shape and expand Sylvan Health’s clinical delivery model. Reporting to the Senior Vice President of Operations, this leader manages the Registered Dietitian network and oversees the systems, workflows, and metrics that drive patient engagement and quality care. The role calls for a blend of clinical operations expertise, technology fluency, management skill, and data analysis. Collaboration is central. The Director works closely with Clinical, Growth, Operations, and Customer Success teams to ensure a strong experience for patients and providers. The position covers the full process of delivering, measuring, and improving nutrition services. Key responsibilities Design and scale Sylvan Health’s clinical delivery model Oversee the Registered Dietitian network, including systems and workflows Set and track performance metrics to support quality care and patient engagement Work cross-functionally to deliver a consistent care experience Use data to guide improvements and support growth Requirements Background in clinical operations and care management Experience in startup or rapidly growing environments preferred Understanding of clinical workflows and operational frameworks Ability to scale organizations and build new processes Comfort with data and leading teams toward company goals Clear communicator who values a people-focused approach

We are seeking a highly skilled and dynamic Director/Manager of Clinical Operations to lead our clinical initiatives at Integrated Resources, Inc. This pivotal role requires a strategic thinker with extensive experience in clinical operations, who can drive performance and enhance patient care. You will be responsible for overseeing clinical activities, developing operational strategies, ensuring compliance with regulations, and fostering a collaborative environment among clinical teams.

The Associate Director of Clinical Operations Compliance & Training at Revolution Medicines focuses on upholding compliance and supporting training programs within clinical operations. This role is based in Redwood City, California. Role overview This position centers on maintaining the integrity of clinical operations by ensuring regulatory standards are met. The Associate Director will guide training efforts and help reinforce consistent practices across teams. Key responsibilities Oversee compliance activities related to clinical operations Lead and coordinate training initiatives for staff Promote adherence to regulatory requirements and internal policies Work environment This role operates within a biotechnology setting where attention to detail and commitment to regulatory standards are essential.