Play a key role in the safe, efficient, and effective Investigational Product preparation and administration in clinical trials.
Review and provide input on Investigational Product Preparation Instructions, Site Investigational Product Procedures Manual, and monitoring guidelines.
Establish and maintain good and productive working relationships with internal and external stakeholders.
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.
Responsible for supporting the Programming deliveries of a clinical study or project.
Implements statistical programming aspects of the protocol and the clinical development program.
Ensures high quality is built into own deliverables and the quality delivered by other programmers.
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. They have over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific and focus on quality, professional development, and a supportive culture.
Reviewing patient care notes for clinical data needed for approvals and care plan recommendations.
Monitoring patient adherence across all sites and disease categories.
Recommending alternative therapeutic drug regimens and disease specific treatments according to guidelines.
Shields Health Solutions provides integrated support to patients and physicians. They improve the quality of patient care by personalizing relationships with patients and prescribers to improve medication adherence and promote evidence-based care.
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.
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.
Provide medication management for individuals, including reconciliation and adherence counseling.
Collaborate with the interdisciplinary care team to develop individualized care plans.
Monitor and evaluate medication regimens to ensure clinical criteria are met.
Shields Health Solutions provides integrated support to patients and physicians. They are focused on improving the quality of patient care through personalized relationships with patients and prescribers. They provide equal employment opportunities to all employees and applicants for employment, prohibiting discrimination and harassment of any type.
Performs on-site or remote monitoring visit activities.
Identifies investigators and verifies qualifications and resources.
Trains investigational site staff and supports regulatory submissions.
Ergomed is a rapidly expanding full-service mid-sized CRO specializing in Oncology and Rare Disease. The company has operations in Europe, North America, and Asia, fostering an international culture with employee well-being and career development opportunities.
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.
Deliver coordinated, patient-centered virtual Care Management by telephone or video that improves members' health outcomes.
Create impactful care plans together with members and our diverse care team, helping members achieve their desired goals.
Help members navigate complex medical conditions, treatment pathways, benefits, and the healthcare system in general.
Jobgether uses an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. They identify the top-fitting candidates, and this shortlist is then shared directly with the hiring company.
Monitor the progress of clinical studies at investigative sites, ensuring studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
Coordinate activities to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).
Identify potential study risks and propose solutions on how to mitigate them.
Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences to improve therapies for patients, with a focus on Oncology and Rare Disease. They cultivate a culture, and have high CRA retention rates.
Lead and oversee end-to-end clinical trial operations from study start-up through close-out.
Develop and execute operational plans, timelines, and performance metrics to support successful delivery of assigned studies.
Proactively identify operational risks and implement mitigation strategies to maintain timelines, quality, and compliance.
Centessa Pharmaceuticals plc is a new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data-driven decision-making led by subject matter experts. Their asset-centric model offers a unique R&D logic that has been applied by single-asset companies to improve productivity.
Track and monitor clinical staff training completion, including study-specific and mandatory compliance training.
Support DOA matrix setup and maintenance by confirming training completion and role assignments.
Upload and maintain essential staff training records, certifications, and staff documents in the eISF and associated systems.
Care Access aims to improve the future of health for everyone by bringing research and health services to communities. They operate with hundreds of research locations and mobile clinics across the globe and are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to medical breakthroughs.
Communicate with patients over the phone about the benefits of the Shields Partner Pharmacy program.
Access patient EMRs to review charts and identify medication needs.
Identify necessary supplies for medications and ensure proper handling.
Shields Health Solutions partners with hospitals and health systems to create specialty pharmacy programs. They focus on improving medication access, adherence, and clinical outcomes for patients with chronic and complex conditions. The company is an equal opportunity employer that values diversity and inclusion.
Act as Local Contact Person for Pharmacovigilance for the designated country.
Develop strategy and manage set up activities.
Provide strategic input to internal and external customers and promptly identify and address any risk/potential risk.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They value employee experience, well-being and mental health, acknowledging that a healthy work life balance is a critical factor for employee satisfaction.
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.
Oversees all aspects of study site management to ensure patient safety is protected and quality of data is generated.
Independently conducts all forms of site visits in accordance with the protocol, local laws, ICH-GCP and Precision SOPs.
Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management.
Precision for Medicine is a precision medicine CRO that combines novel clinical trial designs, operational and medical experts, advanced biomarker and data analytics solutions, and a real passion for complex disease states. They strive to ensure employees feel appreciated through a multitude of benefits and value their ideas and contributions.
Serves as a source of medical expertise for clinical project teams.
Provides medical input into the design, planning, initiation and completion of clinical trials.
Responsible for the preparation of the medical components of study protocols and IND and other regulatory submissions.
Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology. They are advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction and seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact.
Train the surgical team to assist in good patient outcomes and verbally support cases during training period.
Maintain and prepare equipment and kits for surgery, including Quality Control audits of equipment and kits.
Calyxo, Inc. is a medical device company focused on improving kidney stone treatment. They are headquartered in Pleasanton, California and led by executives and investors with a track record of commercializing devices within urology.
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.
Performing analysis of workflow and assessment of system needs.
Planning, designing, and testing of systems and interfaces.
Training end-users as required and troubleshooting work involved in systems implementation and maintenance.
Southcoast Health is a not-for-profit, charitable health system with multiple hospitals, clinics, and facilities throughout Southeastern Massachusetts and Rhode Island. They provide inclusive, ethical workplaces where highly skilled caregivers offer world-class, comprehensive healthcare close to home and have been voted ‘Best Place to Work’ for 7 years in a row.