Support operational execution of clinical studies from initial synopsis through final deliverables.
Manage implementation, on-time execution, and conduct of clinical studies, including budget and vendor management.
Oversee cross-functional study teams and ensure compliance with regulations and data integrity.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are committed to continuous innovation in cell therapy.
Monitor clinical trial sites to ensure compliance with protocols, SOPs, and regulatory requirements.
Review electronic medical records and source documentation for accuracy and data integrity.
Support site staff and contribute to development of trial materials, SOPs, and training guides.
Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies to improve transplant outcomes for blood cancer patients. The company maintains a start-up culture with an entrepreneurial spirit and emphasis on camaraderie.
Lead the design and execution of clinical studies, including investigator-initiated trials and registries.
Develop evidence-generation strategies supporting CLIA validation and reimbursement pathways.
Build relationships with key opinion leaders in head & neck oncology and represent CareDx at conferences.
CareDx, Inc. is a leading precision medicine solutions company focused on transplant patients, offering products, testing services, and digital healthcare solutions. With a focus on genomics-based information, the company aims to improve the lives of organ transplant patients worldwide.
Provide regulatory strategy and guidance across the clinical development lifecycle, including submissions to Regulatory Authorities and Ethics Committees.
Coordinate and prepare regulatory documents such as CTA/IND, annual reports, amendments, orphan designations, and marketing applications.
Represent Global Regulatory Affairs at project team meetings, lead submission projects, and mentor Regulatory Affairs Specialists.
Precision for Medicine is a CRO that integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences, focusing on Oncology and Rare Disease. They are a growing global team that values employee contributions and fosters an environment where ideas are valued and nurtured.
Support Clinical Trial Managers with study start-up, protocol development, and Trial Master File preparation.
Coordinate with clinical sites on documentation, training, and compliance with FDA and GCP requirements.
Assist with tracking study payments and providing operational support across the full study lifecycle.
The company is a partner organization specializing in clinical research and development, operating through Jobgether. It offers a structured clinical operations environment with cross-functional teams and professional growth opportunities.
Monitor and own the progress of clinical studies at investigative sites, ensuring compliance with protocols and regulations.
Coordinate study setup activities, including investigator identification and regulatory submissions, while mentoring junior staff.
Interact directly with clients, manage payments, and participate in proposal activities, with travel up to 50-60%.
Precision for Medicine is a specialized CRO that combines agility with scientific expertise to support innovative clinical development programs. They foster a collaborative environment that values quality, accountability, and professional development, with a global team of experienced professionals.
Lead and coach a team of Clinical Study Operations professionals overseeing device-based clinical trials from feasibility to close-out.
Drive domain-level ClinOps initiatives including process standardization, tooling, and data quality improvements.
Represent ClinOps in business development conversations, feasibility discussions, and Investigator Meetings, ensuring operational readiness.
Beacon Biosignals transforms precision medicine for the brain, offering at-home EEG and diagnostic platforms for neurological, psychiatric, and sleep disorders. They are a remote-first, distributed company with hubs in Boston, New York, and Paris, emphasizing curiosity, sound judgment, and empathy.
Oversee study start-up, site activation, and close-out activities while managing study plans and essential documents.
Collaborate with cross-functional teams, sponsors, and vendors to ensure timely and compliant project execution.
Mentor CTA team members and contribute to TMF quality, inspection readiness, and regulatory compliance.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. They are a collaborative community committed to making a meaningful impact on global health, valuing team members and empowering them.
Independently manages the study start up activities for multi-center, US and/or global based studies.
Performs on-site visits (feasibility, SIV, IMV, Close-Out) with CRO CRAs as needed to assess the sites’ and CRA’s overall performance.
Provides monitoring oversight by reviewing monitoring schedules, metrics and reports.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are pioneering a transformational approach to treating cancer by harnessing the immune system, and are committed to continuous innovation in cell therapy.
Lead medical and scientific review of promotional and non-promotional materials for assigned products and markets.
Ensure scientific accuracy, regulatory compliance, and fair balance in content, collaborating with cross-functional teams.
Develop and review medical content, including scientific narratives and medical information, adhering to industry standards.
EVERSANA provides next-generation commercialization services to the life sciences industry, helping bring innovative therapies to market. With over 7,000 employees globally, they serve more than 670 clients and are certified as a Great Place to Work.
Lead product safety surveillance strategies and risk management for investigational products.
Oversee medical review of safety data and ensure compliance with global pharmacovigilance regulations.
Build pharmacovigilance infrastructure and manage vendor partnerships as the company grows.
Oruka Therapeutics develops novel biologics for chronic skin diseases like plaque psoriasis. It is a growing biotechnology company with a startup culture focused on making a difference.
Serve as the primary point of contact for assigned protocols, linking Country Operations with the clinical trial team.
Manage project timelines, deliverables, and performance for clinical studies from feasibility to close out.
Ensure compliance with ICH/GCP, country regulations, and company policies while leading local study teams.
Merck is a global healthcare leader with a diverse range of prescription medicines, vaccines, and animal health products. With over 100 years of history, the company employs tens of thousands worldwide and fosters a culture of innovation and inclusivity.
Define and execute the clinical platforms roadmap and lead end-to-end product development.
Oversee platform operations, PMO governance, and delivery execution across teams and vendors.
Partner with clinical and commercial teams to position platforms as differentiated and scalable.
Fortrea is a global contract research organization supporting the development of life-saving therapies through clinical trial services. With a large, global team, Fortrea fosters a collaborative culture focused on innovation and patient-centric delivery.
Lead the clinical team to inform organizational initiatives and drive program innovation.
Manage a pool of clinician experts to support health care organization partners and high-priority workstreams.
Oversee rapid cycle clinical program enhancements and ensure innovation aligns with clinical best practices.
Upstream USA is a national nonprofit dedicated to ensuring equitable, patient-centered contraceptive care is available to everyone. It is the largest contraceptive organization in the country, operating in 37 states and D.C., with a culture of aggressive growth and measurable outcomes.
Provide medical direction and scientific leadership for the pancreatic and colorectal cancer programs.
Lead clinical study subteams, design efficient clinical trials, and monitor safety and efficacy data.
Contribute to global regulatory filings, author clinical documents, and present at scientific meetings.
Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for patients with cancer. The company's programs target the RAS/MAPK pathway, and it is driven by an audacious mission to erase cancer.
Lead safety evaluations and benefit-risk assessments for assigned products.
Provide medical leadership for pharmacovigilance activities across development and marketed products.
Support regulatory submissions and health authority interactions, including preparing responses to RFIs.
Alphanumeric is a staffing and recruiting company that places professionals in contract roles with top organizations. This role is a 1-year contract with a major pharmaceutical company, supporting its global Safety Evaluation & Risk Management function.
Assist in planning and implementing clinical research protocols including subject screening and enrollment.
Collect, organize, and analyze research data; assist with specimen collection and lab processing.
Support manuscript preparation, IRB submissions, and grant proposals.
OHSU is Oregon's only public academic health center, providing patient care, groundbreaking research, and training for healthcare professionals. As Portland's largest employer, it offers opportunities for growth across a diverse system of hospitals and clinics.
Serve as the primary Clinical QA point of contact for a Phase 3, global study.
Collaborate with cross-functional groups to support study start-up and execution.
Perform clinical site audits and support inspection readiness.
Priovant is a biopharmaceutical company committed to developing therapies for autoimmune diseases. They have a small, collaborative team with a hands-on culture.
Perform on-site or remote pre-study, initiation, interim, and close-out monitoring visits to ensure adequate facilities and staff.
Identify investigators and verify qualifications, resources, and staff for conducting clinical studies.
Train investigational site staff and support regulatory submissions as applicable.
Ergomed is a specialist clinical research organization focused on rare disease and oncology trials. With a collaborative international team across North America, South America, Europe, Asia, and Australia, the company values teamwork, flexibility, and work-life balance.
Manage day-to-day clinical trial operations, including CRO/vendor oversight and site management.
Lead cross-functional study teams, develop study documents, and implement risk mitigation strategies.
Ensure high-quality deliverables within timelines and budget, from start-up through close-out.
Ultragenyx is a biopharmaceutical company dedicated to developing life-changing treatments for rare diseases. They foster a supportive and inclusive culture focused on learning and growth, with a global team committed to innovation.