Lead data management activities for assigned clinical trials, ensuring quality and integrity of data.
Serve as subject matter expert on multidisciplinary teams and oversee CRO/vendor compliance.
Support temporary remote role requiring 20 hours/week and US work eligibility.
Penumbra is a global healthcare company focused on innovative therapies for challenging medical conditions. It designs, develops, manufactures, and markets novel products, and fosters a collaborative teamwork environment where learning is constant and performance is rewarded.
Lead and oversee clinical data management activities across assigned studies, ensuring high-quality data in compliance with ICH-GCP and company SOPs.
Manage CROs and external vendors, including database start-up, data cleaning, and database lock, while maintaining quality, timelines, and budget.
Collaborate cross-functionally with Biometrics, Clinical Operations, Medical, and other teams to drive data management milestones and inspection readiness.
We are developing novel biologics designed to set a new standard for the treatment of chronic skin diseases like plaque psoriasis. As a Nasdaq-listed startup, we foster a vibrant, inclusive culture where everyone is encouraged to bring their authentic selves to work.
Independently manage site monitoring activities for wound care clinical trials, ensuring data integrity and GCP compliance.
Collaborate with sponsors, investigators, and cross-functional teams to resolve issues and support effective trial delivery.
Contribute to study planning, regulatory documentation, audit readiness, and patient recruitment oversight.
The company is a clinical research organization focused on wound care trials. It offers a collaborative, international, and innovation-driven culture with opportunities for professional development and flexible remote work.
Coordinate clinical trial site activities and support successful site start-up and activation.
Serve as a primary point of contact for investigative sites, facilitating communication among clinical teams, sponsors, CROs, and regulatory stakeholders.
Ensure compliance with ICH/GCP guidelines, manage essential documentation, regulatory submissions, and site activation milestones.
This role is listed on behalf of a partner company in the clinical research sector, focused on coordinating site start-up and activation for clinical trials. The culture emphasizes operational excellence, collaboration, and patient safety, with a remote working environment.
Perform on-site or remote pre-study, initiation, interim, and close-out monitoring visits to ensure adequate facilities and staff.
Identify investigators and verify qualifications, resources, and staff for conducting clinical studies.
Train investigational site staff and support regulatory submissions as applicable.
Ergomed is a specialist clinical research organization focused on rare disease and oncology trials. With a collaborative international team across North America, South America, Europe, Asia, and Australia, the company values teamwork, flexibility, and work-life balance.
Partner with cross-functional teams and study sites to support clinical operations across all trial phases.
Perform remote monitoring of clinical trials and serve as secondary contact for sites supporting CRAs.
Ensure proper reporting and follow-up of SAEs, address non-compliance issues, and assist with audit/inspection readiness.
Premier Research is a global clinical research, product development, and consulting company helping biotech, specialty pharma, and MedTech innovators turn breakthroughs into new treatments. The company fosters a collaborative culture focused on agility, continuous learning, and making an impact.
Lead Risk-Based Quality Management (RBQM) activities to ensure clinical trial quality and alignment with study objectives.
Oversee centralized monitoring, including developing Central Monitoring Plans, reviewing KRIs/QTLs, and maintaining dashboards.
Collaborate with global teams and sponsors to identify risks, recommend mitigations, and support inspection readiness.
A global clinical research organization focused on advancing medical innovation and improving patient outcomes through high-quality clinical trials. The company fosters a collaborative, multidisciplinary remote environment with international teams and a strong emphasis on regulatory compliance and data-driven decision-making.
Collaborate with project teams to support study startup and serve as primary point of contact for clinical sites.
Provide training on Beacon's devices and protocols, monitor progress, and maintain GCP/ICH compliance.
Address operational issues via Zendesk and Asana and deliver actionable site feedback for workflow improvements.
Beacon Biosignals is transforming precision medicine for the brain with at-home EEG and cardiopulmonary monitoring platforms for clinical development and diagnostics. They foster a remote-first culture with hubs in Boston, New York, and Paris, emphasizing curiosity, simplicity, and empathy.
Lead clinical data management strategy and execution across the portfolio to ensure data integrity and regulatory submission readiness.
Own end-to-end database lock planning and execution for pivotal trials, ensuring on-time, audit-ready locks.
Build and lead a fit-for-purpose data management team, including internal staff and outsourced functions, and establish SOPs and governance.
Prilenia is a private biopharmaceutical company focused on bringing transformative medicines to people with neurodegenerative diseases such as ALS and Huntington’s disease. They are a small to mid-size clinical-stage organization with a highly committed global team and a flexible, mostly remote culture.
Manage all aspects of clinical trial data management from study start-up to post-database lock for assigned projects.
Oversee database development, edit check specifications, data entry quality, and data management documentation.
Act as the lead data management contact, coordinating with sponsors, vendors, and cross-functional teams.
Precision Medicine Group is a global provider of clinical development, data management, and related services for the biopharmaceutical industry. The company maintains a collaborative, quality-driven culture and values diversity and inclusion across its global teams.