Lead the preparation and review of clinical study reports, protocols, and other regulatory documents.
Perform medical writing tasks of high complexity and critical importance to ongoing projects.
Collaborate with cross-functional teams to gather and synthesize information for document development.
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.
Ensures complete study scoping, including testing requirements, facilities and other nuances.
Provides technical details to study team for study designs and updates.
Conducts investigations and assists with implementation of corrective actions, as needed.
ACM Global Laboratories impacts patients and their families by being purposefully patient-driven. Their dedication is reflected in the high-quality work provided by their teams every day around the globe.
Serve as a subject-matter expert on global clinical and regulatory writing projects
Lead the writing, review, and coordination of complex documents such as CTD Modules, Clinical Study Protocols, and Clinical Study Reports
Drive development of key clinical documents that align with overall program and submission strategy
Jobgether is a company that uses AI-powered matching to ensure applications are reviewed quickly, objectively, and fairly. Their system identifies the top-fitting candidates and shares this shortlist directly with the hiring company.
Support Dosing Program Lead across assets and may serve as dosing program representative on clinical trial teams
Contribute to the writing and editing of clinical study protocols, clinical study reports, manuscripts, and other study-related documents
Contribute to ongoing data review and cleaning, data summarization and analysis in support of abstracts, manuscripts and presentations for external meetings and conferences
Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Founded in 2019, they are continuously expanding their presence and global footprint with a team of patient-centric, intelligent individuals.
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.
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.
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.
Bring medical and scientific expertise to the design, execution, and interpretation of clinical studies ensuring patient safety and scientific integrity
Author and oversee key clinical documents including protocols, amendments, informed consent forms, investigator brochures, clinical study reports, and regulatory submissions
Review, analyze, and interpret emerging clinical data (safety, efficacy, PK/PD) to identify trends and issues, ensuring timely resolution through cross-functional collaboration
Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Founded in 2019, they are continuously expanding our presence and global footprint, searching for high-impact individuals in various clinical, technical and business operations domains to strengthen our team.
Perform discovery visits to access sites for research partnerships.
Provide protocol and product/procedural training to clinical sites.
Assist sites with pre-screening patients to ensure appropriateness for clinical study, as applicable.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our 114,000 colleagues serve people in more than 160 countries, providing a portfolio of life-changing technologies across the spectrum of healthcare.
Develop and maintain a structured research roadmap aligned with organizational clinical priorities.
Analyze large clinical and administrative datasets using appropriate statistical methods.
Lead authorship and coordination of abstracts, posters, and manuscripts for CV conferences and journals.
Heartbeat Health is the leading virtual-first cardiovascular care company. They provide patients convenient, high-quality heart care, leveraging real-time data and AI-powered insights to empower providers and patients with personalized treatment plans. The company is remote-first with flexibility and autonomy at the core.
Assist with investigator recruitment activities and site feasibility tasks.
Perform essential document collection, review, and maintenance activities.
Act as site contact for study and site management issues.
Precision for Medicine supports life sciences companies in the use of precision medicine by helping them design and execute clinical trials. They focus on biomarker-led strategies and have expertise in data science, clinical trial management, and laboratory services.
Responsible for delivery of site activation readiness within the assigned country/sites.
Preparation of Clinical Trial Application Forms and submission dossier for submission to CA, EC, and other applicable local bodies.
Act as SME for collection and maintenance of site level critical path to Site Activation data points.
Precision Medicine Group is an organization that works in the medical field. They are an Equal Opportunity Employer, with employment decisions made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
Design and execution of ongoing and new clinical studies, contributing to the clinical development plan.
Lead and/or serve as the clinical science representative on clinical studies to deliver high quality data for registration.
Partner with stakeholders to deliver clinical programs for registration and launch.
Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Founded in 2019, they are continuously expanding their presence and global footprint and searching for high-impact individuals.
Responsible for a range of editorial services and leading the editorial work for assigned accounts.
Copy edit each project for correct spelling, grammar, consistency and preparing submissions of pharmaceutical marketing materials.
Prioritize multiple deadline-sensitive projects, take ownership, and work independently.
Precision Medicine Group is a company that works in the medical communications field. They are an equal opportunity employer, and employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
Support the design, specifications, and development of eCRFs
Develop Data Management Plan documents
Manage effective communication of data issues and discrepancies to study sites via the query management process
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. They are committed to transforming the future of treatment for autoimmune disease and redefining what’s possible.
Facilitating negotiations of site agreements and budgets to ensure alignment with the site activation plan.
Customizing and preparing country- and site-specific agreements and organizing their translations.
Tracking the status of site agreement and budget negotiation.
They are a company that cares for their staff, clients, partners and the quality of their work. A dynamic, global company founded in 1995, they bring together more than 3000 driven, dedicated and passionate individuals, working on the front line of medical science, changing lives, and bringing new medicines to those who need them.
Conduct and report all types of onsite monitoring visits as well as remote visits.
Perform CRF review, source document verification and query resolution.
Be responsible for site communication and management.
PSI is a dynamic, global, mid-size company founded in 1995, bringing together more than 3,000 driven, dedicated, and passionate individuals. They work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
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.
Ensure the quality and compliance of clinical trials.
Interpret regulatory requirements.
Lead the development and implementation of quality assurance strategies.
Jobgether is a company, posting this job on behalf of a partner company. They use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements.