Lead protocol development and study start-up for clinical trials
Develop and manage study-specific documents and drive issue resolution
Partner with cross-functional teams to improve process efficiency
DLH delivers improved health and national security readiness solutions for federal programs through science research, systems engineering, and digital transformation. The company brings a unique combination of government sector experience and unwavering commitment to innovation to improve lives.
Collaborate across sophisticated evidence synthesis projects, developing deliverables like protocols and technical reports.
Manage day-to-day client communications and delegate tasks to junior researchers.
Provide mentorship and direction while independently completing complex job responsibilities.
Precision Medicine Group is a global portfolio organization that provides evidence synthesis services for health technology assessments. The company has a start-up culture in a well-funded established organization.
Provide leadership and mentorship across regional clinical trials while ensuring high-quality study execution with minimal travel.
Oversee monitoring visit reports, manage study risks, and ensure compliance with corrective measures at country and regional levels.
Collaborate with cross-functional teams, lead project calls, and deliver training to support data integrity and site performance.
PSI CRO is a privately owned, global Contract Research Organization dedicated to advancing medical science and bringing new therapies to patients worldwide. Founded in 1995, the company has over 3,000 employees and prides itself on long-term stability, having never undergone a merger, acquisition, or company-wide layoffs.
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.
Lead the full scope of Biostatistics activities for assigned clinical programs, including study design, analysis, and regulatory submissions.
Collaborate cross-functionally with Clinical, Medical, and Regulatory teams to ensure quality and timely delivery of statistical outputs.
Oversee CROs and internal teams, supervise statistical programming, and drive continuous improvement in biostatistics processes.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. The company is headquartered in Radnor, Pennsylvania and operates as a fully remote organization.
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.
Provide high-level logistical support for clinical study operations, including study start-up, site management, and monitoring.
Develop and manage study-related documents such as protocols, informed consent forms, and monitoring plans.
Oversee clinical trial supplies, vendor management, and ensure compliance with regulatory requirements.
Natera is a global leader in cell-free DNA testing dedicated to oncology, women’s health, and organ health. Our team consists of highly dedicated professionals from world-class institutions who care deeply for our work and each other, working hard and growing quickly.
Provide statistical oversight and lead complex programs such as NDA/BLA/MAA submissions.
Consult with clients on clinical trial study design and regulatory strategy.
Author statistical analysis plans and review statistical output for accuracy.
Precision Medicine Group provides statistical leadership and support for clinical development, consulting with clients on trial design and regulatory strategy. The company is a global organization that values collaboration, service, and accountability, fostering a culture of mentoring and innovation.
Lead the clinical development strategy and oversee programs from IND through Phase III, ensuring scientific and regulatory excellence.
Manage global vendor, investigator, and KOL relationships to drive successful trial execution and pipeline progression.
Build and mentor a high-performing team while ensuring budget, timeline, and quality targets are met.
ProKidney is a clinical-stage biopharmaceutical company focused on developing innovative therapies for kidney disease. The company fosters a culture of scientific rigor, collaboration, and continuous improvement, with a commitment to quality and compliance.
Provide scientific and strategic DMPK guidance across a biologics portfolio, supporting monoclonal antibodies, bispecifics, and targeted-delivery platforms.
Design and lead PK, bioanalysis, and immunogenicity studies to optimize candidate selection and progression.
Collaborate with cross-functional teams and external partners to ensure regulatory readiness and support IND filings.
Pioneering Medicines is the in-house drug development unit of Flagship Pioneering, focused on creating novel treatments from Flagship's scientific platforms. It is part of a larger organization known for innovation, with a collaborative and fast-paced culture.