Prepare and ensure completeness of Trial Master Files for internal and external studies.
Maintain the Trial Master File, creating file structure and indexing contents.
Communicate with client sponsors, project managers, monitors, and sites to ensure compliance.
Celerion is a performance-driven drug research company operating in the clinical research industry. They focus on integrity, trust, teamwork, and respect, offering a strong developmental environment.
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.
Serve as TMF subject matter expert, partnering with study teams to ensure documentation is complete and inspection ready.
Lead the setup, maintenance, and quality review of electronic Trial Master Files, monitoring health and driving issue resolution.
Collaborate with clinical operations and vendors to improve TMF processes and support regulatory inspections.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company developing therapies for central nervous system disorders. With a focus on trust, ownership, curiosity, and results, they foster a collaborative, inclusive culture.
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.
Prepare and manage clinical trial submissions to Competent Authorities and Ethics Committees for initial and subsequent approvals.
Collect, review, and maintain essential documents for site activation, ensuring compliance with ICH-GCP and local regulations.
Act as Subject Matter Expert, mentoring less-experienced staff on site start-up activities and regulatory requirements.
Precision Medicine Group is a life sciences organization that provides clinical trial and regulatory services to biopharmaceutical companies. They are expanding their presence in Latin America and foster a collaborative, fast-paced culture focused on precision medicine.
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.
Conduct remote and onsite monitoring activities including Site Initiation, Interim, and Closeout Visits.
Review informed consent, source documentation, and case report forms for accuracy and completeness.
Identify, document, and escalate protocol deviations, data quality concerns, and compliance risks.
WHOOP is on a mission to unlock human performance and healthspan, empowering members to perform at a higher level through a deeper understanding of their bodies and daily lives. They are a leading wearable technology company with a collaborative and detail-oriented culture.
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.
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.
Coordinate day-to-day clinical trial operations remotely, ensuring compliance with protocols and regulations.
Support remote patient visits including scheduling, documentation, and follow-up.
Maintain accurate data entry in EDC/CTMS systems and assist with regulatory documentation.
UniTriTeam is a global leader in providing operational, administrative, and technology support to clinical research sites. They have a mission-driven, supportive, and inclusive team culture.
Create and maintain SOPs and guidance documents in compliance with ICH-GCP and federal and local regulations.
Conduct internal study reviews to ensure compliance and prepare official reports with findings and corrective actions.
Collaborate with operations teams to remediate noncompliance and participate in quality investigations and audits.
Headlands Research is dedicated to enhancing clinical trial delivery within communities. Founded in 2018, the company operates 20+ clinical trial sites across the US and Canada and is rapidly expanding.
Critically evaluate scientific literature and produce accurate regulatory documents.
Manage writing assignments across multiple projects and ensure timely delivery.
Work directly with clients and multidisciplinary teams on regulatory submissions.
A partner company in the pharmaceutical, biotechnology, and medical device sectors is hiring a Senior Medical Writer. The company offers a fully remote environment and opportunities to work on a broad portfolio of clinical and regulatory documents.
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.
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.
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.
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.
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.
Provide high-level logistical support for clinical study operations, including study start-up, site management, and monitoring.
Develop and manage study-related documents such as protocols, informed consent forms, and monitoring plans.
Oversee clinical trial supplies, vendor management, and ensure compliance with regulatory requirements.
Natera is a global leader in cell-free DNA testing dedicated to oncology, women’s health, and organ health. Our team consists of highly dedicated professionals from world-class institutions who care deeply for our work and each other, working hard and growing quickly.