Serve as primary point-of-contact and escalation point for clients, coordinating functional services and vendors to meet quality, scope, cost, and time objectives.
Manage study budget and financial health, ensuring projects remain within scope and identifying out-of-scope activities, while overseeing billing and forecasting.
Develop robust project plans with timelines and risk management, ensure quality management including eTMF inspection readiness, and lead internal and client meetings.
Precision for Medicine is a CRO that integrates clinical trial execution with scientific expertise and data sciences to accelerate life-changing therapies, focusing on Oncology and Rare Disease. It is a growing organization that values employee contributions and fosters a collaborative culture.
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.
Responsible for executing one or more elements of clinical studies in compliance with quality standards and regulations.
Supports the Study Project Manager in leading cross-functional study teams and developing study protocols.
Manages vendor selection, oversight, and study-related training, and proactively resolves issues.
AbbVie is a biopharmaceutical company focused on discovering and delivering innovative medicines and solutions for serious health issues. It is a large global organization with a diverse workforce and a commitment to integrity and innovation.
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.
Oversee day-to-day operations of clinical trials, ensuring compliance with GCP, FDA, and ICH guidelines while managing CROs and vendors.
Serve as primary point of contact for CROs and trial vendors, tracking performance metrics, budgets, and timelines to ensure project success.
Collaborate with cross-functional teams to prioritize data integrity, participant safety, and quality control, with travel required up to 30%.
Peptilogics is a surgical therapeutics company dedicated to curing and preventing medical device-related infections. They are a clinical-stage biotech with a small, agile team and a culture of proactive, independent thinking.
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.
Manage global, multi-center clinical research projects in various therapeutic areas.
Deliver projects on time, within budget, and to high quality standards while leading multifunctional teams.
Serve as primary client contact, participate in bid defenses, and ensure compliance with procedures.
PSI is a leading Contract Research Organization with 30 years of experience in the industry, offering a balance between stability and innovation. We focus on delivering quality and timely services across various therapeutic indications, investing in our people's professional development.
Support study execution by managing meeting logistics, documenting decisions, and tracking action items.
Partner with Clinical Operations and site monitors to ensure protocol compliance and quality standards.
Responsible for filing site-level documents into Trial Master Files and assisting with regulatory submissions.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. As a small, mission-driven team, we foster a collaborative culture built on trust, ownership, curiosity, and results.
Deliver evidence-based feasibility assessments for pre-award, post-award, and standalone engagements across global clinical trials.
Translate clinical protocols, epidemiology, and competitive landscape data into clear country, site, and recruitment recommendations.
Partner with Business Development, Clinical Operations, and Medical teams to present analyses and support bid-defence meetings.
Precision for Medicine combines clinical-trial execution, scientific expertise, laboratory capabilities, and advanced data sciences to help life sciences organizations improve the speed, cost, and likelihood of successful clinical development. The organization has a strong focus on oncology and rare diseases, offering the opportunity to contribute to complex programs that bring meaningful therapies to patients.
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.
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.
Manage site activation and regulatory submissions for clinical trials in Spain.
Oversee contract and budget negotiations with sites to ensure timely approvals.
Collaborate with cross-functional teams to maintain project documentation and timelines.
Precision for Medicine is a global Clinical Research Organization specializing in precision medicine for rare diseases and oncology. The company is experiencing continued growth and values operational excellence and regulatory expertise.
Complete the CRA Training Program (12-14 weeks) to gain the skills needed as a primary CRA.
Conduct site visits (PSSV, SIV, IMV, COV) and manage site performance, data quality, and patient safety.
Build strong relationships with site personnel and ensure effective communication with the Clinical Study Team.
BeOne is a global oncology company discovering and developing innovative, affordable treatments for cancer patients worldwide. Our growing global team of more than 11,000 colleagues fosters a collaborative, patients-first culture.
Conduct and report all types of onsite monitoring visits, perform CRF review, source document verification, and query resolution.
Be responsible for site communication and management, supervise study activities, timelines, and schedules on the country level.
Support regulatory team in preparing documents for study submissions and participate in feasibility research.
PSI is a leading Contract Research Organization with over 30 years of experience, offering a balance of stability and innovation. The company focuses on delivering quality and on-time services across a variety of therapeutic indications.
Manage end-to-end clinical studies ensuring on-time and on-budget delivery with high quality standards.
Lead multifunctional study management teams and serve as primary point of contact for client study teams.
Oversee project planning, resource allocation, and financial management while ensuring regulatory compliance.
Science 37 is a clinical research organization focused on decentralized clinical trials. They value employee well-being and provide an equal opportunity workplace.
Manage global, multi-center clinical research projects in a variety of therapeutic areas.
Deliver projects on time, within budget, and in accordance with high quality standards.
Lead and mentor project teams, and serve as the primary point of contact to clients on all project matters.
PSI is a leading Contract Research Organization with 30 years experience in the industry, offering a perfect balance between stability and innovation to both clients and employees. They focus on delivering quality and on-time services across a variety of therapeutic indications.
Oversee clinical study operations from startup through close-out, ensuring quality and compliance.
Act as primary operational partner to sponsors, project teams, and clinical sites.
Foster a culture of quality by coaching peers on GCP compliance and documentation discipline.
Beacon Biosignals is transforming precision medicine for the brain, offering EEG and cardiopulmonary platforms for clinical development and diagnostics. The company has office hubs in Boston, New York, and Paris, and fosters a first-class remote work culture with a focus on diversity and impact.
Develop study budgets for bids and change orders, and manage budgets throughout clinical project duration.
Manage sponsor contracts, payment schedules, and timesheet systems.
Provide financial analysis and reporting for clinical projects.
PSI is a leading Contract Research Organization with more than 25 years on the market, offering a perfect balance between stability and innovation. They focus on delivering quality and on-time services across a variety of therapeutic indications.
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.