Lead diverse CRO teams through Inspection Readiness preparation for a global oncology protocol. - Manage document retrieval in pTMF, ensuring all documents are present and correctly filed. - Coordinate with CROs to complete and update a ~500-item Inspection Readiness checklist.
Artech is an IT staffing company that provides technical expertise to fill gaps in clients' skill-set availability. As the 10th largest IT staffing company in the US, it offers flexible project planning and execution solutions.
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 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.
Leads the planning, conduct, and oversight of clinical studies per scope of work, ensuring compliance with protocols, SOPs, and regulatory requirements.
Acts as primary clinical point of contact for clients, develops study documents, and drives site feasibility and recruitment strategies.
Manages clinical teams, training, vendor oversight, and ensures data quality and timely deliverables across study phases.
Precision Medicine Group is a clinical research organization that provides outsourced clinical trial management services to pharmaceutical and biotechnology companies. The company fosters a collaborative culture focused on quality and compliance, and employs a team of experienced clinical professionals.
Creates and maintains project timelines in MS Project or similar systems, ensuring accurate updates and distribution to team members.
Coordinates internal and external meetings, prepares agendas, takes minutes, and files documentation in the Trial Master File.
Manages study-specific training, system access, and supplies, while supporting team communications and vendor coordination.
Precision for Medicine is a Clinical Research Organization specializing in precision medicine, combining novel trial designs, operational expertise, and advanced biomarker analytics to advance oncology and rare disease treatments. The company fosters a collaborative, detail-oriented culture with a focus on professional growth and teamwork.
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.
Act as primary representative for eClinical Solutions and sponsor data management interaction, ensuring quality and timelines within scope.
Define specifications and collaborate with technical teams on configuration of elluminate for data cleaning strategy and oversight.
Perform quality oversight and data trending via elluminate reporting to identify risks and develop mitigation strategies.
eClinical Solutions helps life sciences organizations accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud. The company is a people-first organization with an inclusive culture, recognized as a 2025 Top Workplaces USA Award winner for Remote Work.
Provide data management support for clinical trials from start-up to post-database lock under supervision.
Assist in developing CRF specifications, building and testing clinical databases, and conducting user acceptance testing.
Review and query clinical trial data, perform medical coding, and coordinate with sponsors and vendors.
Precision for Medicine is a global precision medicine clinical research services organization that improves clinical research and development for new therapeutics. They integrate clinical operations, laboratory expertise, and data sciences, with a focus on oncology and rare disease.
Manage end-to-end clinical trial agreement process for global multi-site trials.
Develop study-specific CTA strategy and negotiate CTAs and budgets directly with sites.
Present progress to stakeholders and ensure deliverables are met within agreed timelines.
Medpace is a full-service clinical contract research organization providing Phase I-IV clinical development services to biotechnology, pharmaceutical, and medical device industries. They employ more than 5,000 people across 40+ countries and foster a culture of people, purpose, and passion.
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.
Manage execution of study-level activities, including creating trial documents and overseeing vendor delivery and budgets.
Coordinate country and regional trial management, aligning feasibility strategies and mitigating local risks.
Support program-level compound training and mentor new team members in Trial Management.
Johnson & Johnson is a global healthcare innovator focused on preventing, treating, and curing complex diseases through Innovative Medicine and MedTech. With a large workforce, they emphasize an inclusive work environment guided by their Credo, respecting diversity and dignity.
Provide comprehensive project coordination and administrative support for clinical research studies.
Coordinate meetings, maintain project documentation, and monitor tracking systems.
Support compliance with internal processes and assist with study startup, maintenance, and closeout activities.
The company is a clinical research organization that supports the development of life-changing therapies through innovative programs. It operates with global teams and fosters a collaborative, inclusive work environment committed to teamwork, integrity, trust, and respect.
Manage clinical operations including study management, biospecimen acquisition, and regulatory compliance.
Lead and mentor a team of CRAs and clinical trial logistics personnel.
Develop and implement processes and tools for high-quality trial management.
Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. They are dedicated to delivering better solutions and have an innovative culture focused on collaboration and cutting edge solutions.
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.
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.
Lead the preparation of complex clinical and regulatory documents including Clinical Study Protocols, Clinical Study Reports, and Investigator Brochures.
Collaborate with clinical development teams and stakeholders to produce accurate, compliant, and scientifically robust documentation.
Manage document timelines, review cycles, and project deliverables while ensuring quality standards and regulatory requirements are met.
Our partner is a specialized medical writing team supporting the development of high-quality regulatory documentation for the global pharmaceutical industry. It offers a collaborative, remote environment focused on quality, precision, and scientific communication.
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.
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.
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.