Source Job

• Manage TMF operations activities for multiple complex studies or sponsor portfolios.
• Oversee Trial Master File quality control including planning, tracking, and reporting.
• Support regulatory inspections and sponsor audits while collaborating with cross-functional teams.

This is a global clinical research environment focused on ensuring accuracy, compliance, and quality of essential trial documentation. The company operates with a collaborative international team and values inclusion, professional growth, and purpose-driven healthcare work.

• Lead TMF operations across clinical studies to ensure timely, complete, and inspection-ready documentation in compliance with ICH-GCP and regulatory standards.
• Establish TMF governance, monitor quality metrics, and communicate findings to study teams and leadership.
• Partner cross-functionally to drive process improvements and strategic oversight of CRO-managed TMF activities.

BridgeBio pioneers a 'moneyball for biotech' approach, pooling early-stage research to reduce risk and accelerate innovation for life-changing medicines. They foster a culture of curiosity and experimentation with a focus on ethics.

• Lead TMF activities for clinical trials across start-up, maintenance, close-out, and archive phases.
• Oversee eTMF health, quality issue workflows, and compliance with regulatory standards.
• Support TMF document processing, audits, and continuous improvement initiatives.

Akero Therapeutics is a clinical stage biopharmaceutical company focused on developing transformational treatments for serious metabolic diseases such as MASH. They are part of Novo Nordisk and foster a collaborative culture with diverse skill sets.

• 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.

• Conduct quality control reviews of participant visits and source documentation in the CRIO eSource system to ensure compliance with GCP, ALCOA principles, and client standards.
• Identify missing documentation, inconsistencies, protocol deviations, and transcription errors, and document findings in tracking systems.
• Collaborate with site personnel to communicate findings, support corrective actions, and contribute to continuous improvement initiatives.

UniTriTeam is a women-owned global workforce solutions organization specializing in clinical research operations, technology, and strategic staffing support. The team is collaborative, accountable, and committed to delivering excellence and integrity.

• Monitor and oversee progress of clinical studies at investigative sites, ensuring compliance with protocols, SOPs, ICH-GCP, and regulations.
• Coordinate study setup and monitoring activities, including investigator identification, regulatory submissions, and site initiation visits.
• Identify potential study risks and propose solutions, while maintaining an impeccable eye for detail and quality outcomes.

Precision for Medicine, Oncology and Rare Disease is a precision medicine CRO that combines novel clinical trial designs, operational and medical experts, and advanced biomarker and data analytics. They pride themselves on high CRA retention rates and a culture where employees feel appreciated and have impact.

• 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.

• 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.

• 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 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.

• Oversee critical monitoring activities across clinical trials, ensuring compliance with protocols and regulations.
• Collaborate with investigators and site teams to maintain study integrity and operational excellence.
• Support Phase II and Phase III trials in challenging therapeutic areas to improve patient outcomes.

Jobgether uses artificial intelligence to match job seekers with opportunities through a fair and efficient process. As a growing platform, they emphasize collaboration, integrity, and patient impact in their culture.

• Serve as the site manager, ensuring data entry and query resolution, and maintain high-quality data and audit readiness at clinical sites.
• Monitor ongoing compliance to study protocols and site adherence to global regulatory guidelines, including safety reporting, both onsite and remotely.
• Manage device accountability, inventory, distribution, and regulatory documentation to ensure compliance and audit readiness.

Penumbra is a global healthcare company focused on innovative therapies, designing, developing, manufacturing, and marketing novel products for challenging medical conditions. The company sells its products to hospitals and healthcare providers worldwide through direct sales and distributors.

• Support Clinical Trial Managers in the day-to-day execution of clinical trials from start-up through close-out.
• Own critical study coordination workflows such as maintaining trackers, decision logs, and training records.
• Ensure study documentation and training records are complete, current, and audit-ready.

Oura is a health technology company that produces the Oura Ring, a wearable device for tracking sleep, activity, and readiness. It is a quickly growing company with a mission-driven culture focused on employee well-being and innovation.

• 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.

• Oversee clinical operations for a project at a regional/global level, ensuring compliance with protocols and regulations.
• Act as primary liaison between CRAs and clinical project team, providing training, oversight, and assessment.
• Manage site performance, develop study tools, and support enrollment strategies to meet project timelines.

Alimentiv provides clinical services for global clinical trials, specializing in study delivery and monitoring. The company emphasizes quality, compliance, and professional growth, with a team of experienced professionals.

• Conduct on-site or remote monitoring visits including Pre-Study, Initiation, Interim, and Close-Out activities to ensure site adequacy and compliance.
• Verify investigator qualifications, resources, and facilities, and train investigational site staff as necessary.
• Support regulatory submissions and mentor junior staff through co-monitoring visits and training.

Ergomed Group is a clinical research organization (CRO) that helps biopharmaceutical companies develop, deliver, and safeguard therapies in oncology, rare disease, and other complex areas. The company fosters a culture of kindness, curiosity, and a shared sense of purpose, with a diverse team of experts in clinical research, pharmacovigilance, and quality consulting.

• 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.

• Lead end-to-end TMF strategy, including transition from outsourced to in-house operations.
• Ensure TMF health and inspection readiness through governance, quality control, and metrics.
• Serve as TMF subject matter expert and partner cross-functionally for document flow and compliance.

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. The company is guided by core values of collaboration, innovation, and ownership, and is committed to transforming treatment for autoimmune disease.

• 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.

• 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.