Management and operational delivery of the clinical elements within a trial.
Successful execution of assigned trials and ensuring completion of trial deliverables.
Identify challenges to study timelines/deliverables and offer creative action plans.
Precision for Medicine is a precision medicine CRO with a uniquely integrated offering to enable the science of precision medicine. They achieve this by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions. They are dedicated to positively impacting the health and lives of patients around the world, particularly in rare diseases and oncology.
Directs the operational oversight and execution of clinical site start-up.
Manages CRO relationship and oversight to ensure appropriate scope of work.
Develops collaborative relationships with investigative sites.
Bristol Myers Squibb is focused on developing innovative drugs against targets of solid tumors. They are a dynamic biotechnology company headquartered in San Diego, CA, and aim to be the global leader in radiopharmaceuticals.
Oversee a portfolio of 3-5 active trials, supporting Project Leads to ensure trial success.
Manage commercial matters within agreed SOW parameters, own sponsor account relationships, and play a pivotal role.
Line manage 3-5 Project Leads and Project Associates, providing performance reviews and professional development.
Lindus Health is powering biology's century with faster, more reliable clinical trials. They are transforming how people think about developing new treatments, so patients can access breakthrough treatments faster; Lindus Health has powered 100+ clinical trials involving tens of thousands of patients.
Lead the planning, execution, and management of clinical trials.
Ensure compliance with FDA, ICH-GCP, and other regulatory standards.
Supervise and mentor Clinical Research Associates (CRAs) and study coordinators.
Jobgether leverages AI to match candidates with fitting roles, ensuring quick and fair application reviews. They connect top candidates directly with hiring companies, who then manage the final decision-making process.
Clinical quality compliance oversight for our clinical development programs both in the US and internationally.
Independently manage domestic and international risk-based audits of investigator sites, study documents, databases, vendors, partners, and internal systems.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, we are committed to transforming the future of treatment for autoimmune disease.
Considered as the primary point of contact for the investigative site and strengthens AbbVie’s positioning.
Conducts site evaluation, site training, routine, and site closure monitoring activities under supervision.
Develop solid knowledge of therapeutic area, asset and clinical landscape to enable successful patient recruitment.
AbbVie discovers and delivers innovative medicines and solutions that solve serious health issues. They strive to have a remarkable impact on people's lives across several key therapeutic areas.
Assist in design, author and/or review clinical study synopses, protocols, study reports and other study-related documents.
Act as a medical monitor for assigned study and discuss study design with investigators and key opinion leaders.
Track emerging efficacy and safety profile of drugs in clinical trials; inform Clinical Development team of changes in the efficacy/safety profiles.
Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for cancer patients. The company aims to improve cancer treatment by targeting cellular drivers of tumor growth and is publicly traded.
Ensure departmental compliance with all applicable global regulations and Sarah Cannon SOPs.
Establish and lead the clinical operations strategy, setting departmental goals.
Promote strong cross‑functional collaboration with internal stakeholders.
McKesson delivers products to healthcare providers. Every day, McKesson’s employees deliver products to healthcare providers that make a difference in the care and life of a patient, focused on creating an inclusive environment with strong values.
Develop and report key quality metrics across all clinical programs and trials.
Ensure compliance with GCP, ICH-GCP, FDA, EMA, PMDA, and applicable regulations.
Drive inspection readiness at local and global levels.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Their core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of their business.
Coordinate and assist with trial start-up activities.
Facilitate resolution of laboratory queries.
Track and report on study progress.
Freenome is dedicated to changing the landscape of cancer through early detection. They value diversity and do not discriminate based on various statuses protected by law.
Ensure adherence to regulations and contractual obligations.
Develop and update compliance policies and SOPs.
Conduct internal compliance audits and report findings.
Equip is a virtual, evidence-based eating disorder treatment program. They aim to ensure that everyone with an eating disorder can access effective treatment, operating in all 50 states and partnered with most major health insurance plans. Since its founding in 2019, Equip has maintained a fully virtual environment.
Responsible for timelines and quality of CDM deliverables for the assigned studies.
Manages CDM timelines to coordinate and synchronize deliverables with the overall study timelines.
Responsible for the accuracy and completeness of the clinical data collected during a clinical trial.
Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies. They are committed to fair and equitable compensation practices and strive to provide employees with competitive total compensation packages.
Collaborate with dedicated research sites contributing to rare neurological disease research.
Make a significant impact in the scientific community alongside a dedicated team of CRAs.
Encompass important site monitoring and management activities including SIVs Interim and Remote Monitoring Visits as well as Final Onsite and Closeout Visits.
St. Joseph's Hospital and Medical Center is a 571-bed, not-for-profit hospital providing health, social, and support services. They are dedicated to caring for the poor and underserved, and are known for quality quaternary care, medical education, and research.
Accountable for study level tracking as assigned by the Clinical Project Manager.
Ensures patient enrollment activities are conducted in a timely manner and is comfortable communicating with site personnel.
Acts as QC of Trial Master Files; creates, maintains, and closes out TMFs; is key in set up, conduct, and close out of ancillary services.
Akero Therapeutics, a Novo Nordisk company, is focused on discovering and developing transformational treatments for patients with serious metabolic diseases. They are a team of problem solvers dedicated to pursuing bold scientific approaches to build a brighter future for patients.