Provides leadership and strategic direction to the Site Start-up department, contributing to the expansion of people, processes, and systems.
Collaborates with cross-functional teams to secure SSU delivery and client satisfaction on activities such as regulatory submissions and site contracts.
Ensures compliance with regulatory requirements, ICH Guidelines, and Good Clinical Practices for clinical trials.
Lead the study start-up process, developing strategy and coordinating regulatory deliverables to meet targets.
Serve as primary contact for start-up activities, prepare and review regulatory documents, and ensure compliance with ICH-GCP and regulations.
Manage essential document collection, site correspondence, contract negotiations, and support team training and budget monitoring.
Ergomed is a mid-sized contract research organization specializing in oncology and rare disease. The company has a global presence with operations in Europe, North America, and Asia, and emphasizes employee well-being, work-life balance, and career development.
Responsible for preparing and submitting clinical trial applications to Competent Authorities and Ethics Committees, ensuring compliance with local and international regulations.
Manages site start-up activities including essential document collection, informed consent form review, and coordination with investigators and contracts.
Acts as a subject matter expert for regulatory submissions and may support process improvement, training, and mentoring.
Precision for Medicine is a clinical research organization (CRO) that integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences to improve the speed and success rate of bringing therapies to patients, with a focus on Oncology and Rare Disease. It is a growing company with a culture of innovation and collaboration.
Lead site activation strategies and oversee start-up activities across clinical studies.
Manage critical path plans and mitigate risks to ensure timelines are met.
Collaborate with cross-functional teams and clients to improve activation processes.
Our partner is a clinical research organization that supports the delivery of clinical trials. They are a global company with a collaborative culture focused on innovation and operational excellence.
Serve as a subject matter expert for site management and monitoring strategies across complex clinical studies.
Collaborate with clinical teams, investigators, and stakeholders to ensure compliance, data quality, and trial success.
Mentor CRA staff, resolve escalated issues, and support site qualification, initiation, monitoring, and close-out visits.
Jobgether is a platform that uses AI-powered matching to connect candidates with job opportunities. They operate as a global healthcare and technology environment, offering professional growth and innovative solutions.
Monitor and own the progress of clinical studies at investigative sites.
Ensure studies are conducted per protocol, SOPs, ICH-GCP, and all applicable regulations.
Coordinate setup activities including investigator identification and regulatory submissions.
Precision for Medicine is a CRO integrating clinical trial execution with scientific and lab expertise, focusing on Oncology and Rare Disease. They have a strong culture with high CRA retention and emphasize work-life balance.
Manage the identification, outreach, and onboarding of high-performing clinical sites into the North America ASN.
Develop strong relationships with high-priority sites and partners to expand the site network.
Build innovative solutions to grow a pipeline of high-potential sites and enhance clinical trial delivery.
Alimentiv is a clinical research organization that drives clinical trial delivery through site network management. They are a global company with a focus on operational excellence and innovation.
Provide study oversight as primary liaison between CRAs, internal staff, site staff, client personnel, and external vendors.
Ensure clinical monitoring activities comply with SOPs, regulations, GCP, KPIs, and study-specific requirements.
Develop and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996, supporting research behind innovative treatments in pharmaceutical, biotech, and medical device industries. They foster a collaborative community where team members feel valued, supported, and empowered to make a meaningful impact on global health.
You will monitor and own the progress of clinical studies at investigative sites, ensuring studies are conducted per protocol, SOPs, ICH-GCP, and regulations.
You will coordinate all necessary activities to set up and monitor a study, including identifying investigators and preparing regulatory submissions.
You will identify potential study risks and propose solutions to mitigate them, demonstrating an impeccable eye for detail.
Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences to improve the speed, cost, and success rate of bringing life-changing therapies to patients. They have a strong focus on Oncology and Rare Disease, and are proud to share extremely high CRA retention rates compared to industry averages.
Manage clinical elements of trials including site selection, start-up, enrollment, monitoring, and close-out for studies across multiple countries.
Lead CRAs and ensure timeline adherence, quality delivery, and effective communication with cross-functional teams and sponsors.
Identify risks to project timelines, create action plans, and mentor team members while maintaining focus on study priorities.
Precision for Medicine is a precision medicine CRO that combines novel clinical trial designs, biomarker and data analytics, with a focus on rare diseases and oncology. The company is part of Precision Medicine Group, a growing organization dedicated to advancing oncology development and positively impacting patient health.
Develop, mentor, coach and manage CTMs to progress their skillset per quality standards.
Collaborate with management to enhance CTM expectations and procedures for quality and efficiency.
Ensure CTMs have proper resources and training to deliver high-quality study conduct.
Precision for Medicine is a clinical research organization (CRO) that provides clinical trial management services. The company employs a large team of clinical research professionals and emphasizes quality and collaboration.
Manage a team of 6-14 CRAs to ensure excellent study and site performance with strict adherence to local regulations, company SOPs, and ICH GCP.
Provide training, support, and mentoring to CRAs, manage low or non-performance situations, and contribute to capacity planning.
Collaborate with local stakeholders, including CRMs and PLMs, to ensure alignment across monitoring functions and resolve site or CRA operational issues.
We are a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare, supported by a large and diverse workforce.
Provide leadership and mentorship across regional clinical trials while ensuring high-quality study execution with minimal travel.
Oversee monitoring visit reports, manage study risks, and ensure compliance with corrective measures at country and regional levels.
Collaborate with cross-functional teams, lead project calls, and deliver training to support data integrity and site performance.
PSI CRO is a privately owned, global Contract Research Organization dedicated to advancing medical science and bringing new therapies to patients worldwide. Founded in 1995, the company has over 3,000 employees and prides itself on long-term stability, having never undergone a merger, acquisition, or company-wide layoffs.
Manage line management of CRAs, IHCRAs, and CTMs across European regions, ensuring performance and development.
Drive operational excellence initiatives and resource deployment to optimize clinical trial execution.
Partner with leadership to identify quality risks, implement corrective actions, and support workforce planning.
Precision for Medicine is a precision medicine-focused clinical research organization that uses biomarkers and data to advance oncology treatments. The company fosters a culture of collaboration, continuous learning, and high performance.
Serves as clinical trial lead, overseeing study planning, conduct, and oversight per protocol and regulations.
Develops study documents, manages site feasibility, and drives recruitment strategies.
Leads internal clinical team meetings and ensures quality deliverables through metric reporting.
Precision Medicine Group is a life sciences company that supports clinical research and development. The company is large enough to offer a range of benefits and emphasizes a collaborative, ethical culture focused on quality and compliance.
Provide operational leadership and on-site support for multiple clinical research sites, ensuring study execution and performance.
Ensure compliance with GCP, FDA regulations, ICH guidelines, and internal quality standards through audit readiness and CAPA management.
Build trusted relationships with Principal Investigators, site staff, and sponsors to drive collaboration and operational excellence.
We are a leading community site network and home research visit solution provider with 20+ sites and over 2,000 research-experienced healthcare professionals across the U.S. We leverage convenient, trusted healthcare locations, identified patient data, and intelligent technology to accelerate patient access and reduce study costs.
Create and execute clinical operational strategic plans aligned with product strategy and resource allocation.
Build, develop, and train internal staff and external vendors to enhance efficiency and engagement.
Oversee relationships with Contract Research Organizations, vendors, and investigative sites to ensure compliance with FDA and ICH GCP guidelines.
Lycia Therapeutics is a biotechnology company using its proprietary LYTAC platform to develop therapeutics that degrade extracellular and membrane-bound proteins. Founded in 2019, the company has raised $75 million in Series D financing and is headquartered in South San Francisco.
Support feasibility and study start-up activities for clinical research sites in Romania and Moldova, coordinating documents and site communication.
Maintain accurate trackers in Salesforce and Asana, flagging blockers and delays early to ensure timely site activation.
Serve as a day-to-day operational contact for sites, routing questions to appropriate internal, CRO, or sponsor contacts.
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The company has 250+ employees worldwide and is headquartered in Cambridge, Massachusetts, and New York City, with a collaborative and low-ego team environment.
Provide therapeutic and operational leadership throughout the clinical program and project delivery lifecycle.
Collaborate with cross-functional teams to develop effective delivery strategies and resolve operational challenges.
Ensure clinical projects within the assigned franchise are appropriately resourced and aligned with operational goals.
Our partner is a global clinical research organization dedicated to advancing healthcare innovation and improving patient outcomes through high-quality clinical trials. They offer a collaborative and inclusive environment with experienced professionals across global therapeutic and operational teams, focusing on professional growth and meaningful impact.
Oversee clinical site management and ensure compliance with protocols, regulations, and quality standards.
Serve as primary contact for study sites, conducting monitoring visits from pre-study through close-out.
Collaborate with cross-functional teams to support data review, regulatory submissions, and site performance.
Our partner is a global clinical research organization managing monitoring activities across Phase I–IV trials and Real World Evidence studies. It offers a collaborative, fully remote environment focused on improving patient outcomes with professional growth opportunities.
Provide operational leadership and oversight for assigned FSP projects, managing regional trials or supporting complex global trials.
Serve as the primary operational point of contact for clients, coordinating cross-functional activities and monitoring project risks, resource constraints, and quality trends.
Contribute to financial oversight, meeting facilitation, and team onboarding, training, and mentoring.
Precision Medicine Group is a clinical research organization (CRO) focused on supporting clients researching ground-breaking cancer therapies. The company fosters a supportive, collaborative environment that promotes work-life balance and team development.