Leads and oversees global clinical trials from inception through closure, ensuring quality and efficiency.
Manages external vendors, recruitment strategies, and cross-functional team coordination.
Maintains inspection readiness and contributes to risk management and process improvement.
AbbVie discovers and delivers innovative medicines and solutions for serious health issues across immunology, oncology, and neuroscience. The company is a global biopharmaceutical leader with a focus on making a remarkable impact.
Leads the planning, conduct, and oversight of clinical studies per scope of work, ensuring compliance with protocols, SOPs, and regulatory requirements.
Acts as primary clinical point of contact for clients, develops study documents, and drives site feasibility and recruitment strategies.
Manages clinical teams, training, vendor oversight, and ensures data quality and timely deliverables across study phases.
Precision Medicine Group is a clinical research organization that provides outsourced clinical trial management services to pharmaceutical and biotechnology companies. The company fosters a collaborative culture focused on quality and compliance, and employs a team of experienced clinical professionals.
Provides leadership and strategic direction to the Site Start-up department, contributing to the expansion of people, processes, and systems.
Collaborates with cross-functional teams to secure SSU delivery and client satisfaction on activities such as regulatory submissions and site contracts.
Ensures compliance with regulatory requirements, ICH Guidelines, and Good Clinical Practices for clinical trials.
Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. We apply our expertise to trials at all stages from early development through approval, with embedded experience in oncology and rare disease.
Manage a team of 6-14 CRAs to ensure excellent study and site performance with strict adherence to local regulations, company SOPs, and ICH GCP.
Provide training, support, and mentoring to CRAs, manage low or non-performance situations, and contribute to capacity planning.
Collaborate with local stakeholders, including CRMs and PLMs, to ensure alignment across monitoring functions and resolve site or CRA operational issues.
We are a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare, supported by a large and diverse workforce.
Lead all clinical study operations, providing strategic planning and direction from inception through completion.
Serve as the primary contact with sponsors and oversee study budgets, timelines, and vendor management.
Mentor and motivate study team members while ensuring compliance with GCP, protocols, and regulatory requirements.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. Our team of skilled professionals is committed to advancing clinical research with care, integrity, and excellence, fostering a collaborative and supportive culture.
Monitor and oversee progress of clinical studies at investigative sites, ensuring compliance with protocols, SOPs, ICH-GCP, and regulations.
Coordinate study setup and monitoring activities, including investigator identification, regulatory submissions, and site initiation visits.
Identify potential study risks and propose solutions, while maintaining an impeccable eye for detail and quality outcomes.
Precision for Medicine, Oncology and Rare Disease is a precision medicine CRO that combines novel clinical trial designs, operational and medical experts, and advanced biomarker and data analytics. They pride themselves on high CRA retention rates and a culture where employees feel appreciated and have impact.
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.
Conduct on-site or remote monitoring visits including Pre-Study, Initiation, Interim, and Close-Out activities to ensure site adequacy and compliance.
Verify investigator qualifications, resources, and facilities, and train investigational site staff as necessary.
Support regulatory submissions and mentor junior staff through co-monitoring visits and training.
Ergomed Group is a clinical research organization (CRO) that helps biopharmaceutical companies develop, deliver, and safeguard therapies in oncology, rare disease, and other complex areas. The company fosters a culture of kindness, curiosity, and a shared sense of purpose, with a diverse team of experts in clinical research, pharmacovigilance, and quality consulting.
You will monitor and own the progress of clinical studies at investigative sites, ensuring studies are conducted per protocol, SOPs, ICH-GCP, and regulations.
You will coordinate all necessary activities to set up and monitor a study, including identifying investigators and preparing regulatory submissions.
You will identify potential study risks and propose solutions to mitigate them, demonstrating an impeccable eye for detail.
Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences to improve the speed, cost, and success rate of bringing life-changing therapies to patients. They have a strong focus on Oncology and Rare Disease, and are proud to share extremely high CRA retention rates compared to industry averages.
Create and maintain SOPs and guidance documents in compliance with ICH-GCP and federal and local regulations.
Conduct internal study reviews to ensure compliance and prepare official reports with findings and corrective actions.
Collaborate with operations teams to remediate noncompliance and participate in quality investigations and audits.
Headlands Research is dedicated to enhancing clinical trial delivery within communities. Founded in 2018, the company operates 20+ clinical trial sites across the US and Canada and is rapidly expanding.
Lead operational execution of cell therapy trials from startup through close-out, managing timelines, budgets, and vendor oversight.
Ensure compliance with regulatory standards including FDA, EMA, and ICH-GCP, and contribute to protocol development and study documents.
Collaborate cross-functionally with clinical operations, data management, regulatory, and manufacturing teams to drive study success.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. They are guided by core values of collaboration and innovation, fostering a culture of ownership and clarity.
Coordinate and oversee all activities for site activations in accordance with contract, protocol, ICH-GCP, and regulatory requirements.
Act as primary point of contact for Sponsor and internal stakeholders during study start-up, developing strategy and managing regulatory deliverables.
Prepare, collect, review regulatory information for submissions and track essential documents to facilitate efficient site initiation and activation.
Ergomed is a specialist clinical research organization focused on rare disease and oncology indications. With colleagues across North America, South America, Europe, Asia and Australia, we value teamwork, flexibility and a real commitment to work-life balance.
Manage execution of study-level activities, including creating trial documents and overseeing vendor delivery and budgets.
Coordinate country and regional trial management, aligning feasibility strategies and mitigating local risks.
Support program-level compound training and mentor new team members in Trial Management.
Johnson & Johnson is a global healthcare innovator focused on preventing, treating, and curing complex diseases through Innovative Medicine and MedTech. With a large workforce, they emphasize an inclusive work environment guided by their Credo, respecting diversity and dignity.
Oversee strategic planning and execution of global clinical studies.
Manage internal and external resources, including CROs, to ensure quality and compliance.
Lead cross-functional teams and contribute to trial design and budgeting.
Dianthus Therapeutics is a clinical-stage biotechnology company developing novel therapies for severe autoimmune diseases. The company values a culture centered on core principles and aims to elevate patient care.
Oversee critical monitoring activities across clinical trials, ensuring compliance with protocols and regulations.
Collaborate with investigators and site teams to maintain study integrity and operational excellence.
Support Phase II and Phase III trials in challenging therapeutic areas to improve patient outcomes.
Jobgether uses artificial intelligence to match job seekers with opportunities through a fair and efficient process. As a growing platform, they emphasize collaboration, integrity, and patient impact in their culture.
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.
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.
Manage operational activities for all phases of clinical studies, from start-up to close-out.
Provide sponsor oversight of CROs and vendors to ensure compliance and quality.
Support data review, TMF maintenance, and cross-functional collaboration for trial success.
Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company developing off-the-shelf cell therapies for devastating diseases. The company fosters an open, collaborative culture where diverse perspectives are welcomed, with teams working from Berkeley or remotely.
Serve as the site manager, ensuring data entry and query resolution, and maintain high-quality data and audit readiness at clinical sites.
Monitor ongoing compliance to study protocols and site adherence to global regulatory guidelines, including safety reporting, both onsite and remotely.
Manage device accountability, inventory, distribution, and regulatory documentation to ensure compliance and audit readiness.
Penumbra is a global healthcare company focused on innovative therapies, designing, developing, manufacturing, and marketing novel products for challenging medical conditions. The company sells its products to hospitals and healthcare providers worldwide through direct sales and distributors.
Develop and maintain successful working relationships with study sites, serving as the primary point of contact for clinical trial operations.
Conduct monitoring visits to ensure compliance with protocols, GCP, and regulatory requirements, preparing high-quality reports.
Collaborate with cross-functional teams including Clinical Project Managers, Data Management, and Regulatory Affairs to ensure end-to-end study execution.
CVRx pioneers unique therapies that harness and harmonize the body's natural systems, benefiting society and making CVRx a universal role model in healthcare. The company values commitments to others and fosters a culture of teamwork, collaboration, and positivity in a purpose-driven startup environment.