• Coordinates, oversees and completes functions on assigned trials activities • Performs department, Internal, Country and Investigator file reviews • Ensures tasks are performed on time, within budget and to a high quality standard • Supports study specific documentation maintenance and global support with specific systems • Provides system support (i.e. GoBalto & eTMF) • Supports scheduling and organization of client and internal meetings • Reviews and tracks local regulatory documents • Analyzes and reconciles study metrics

• End-to-end oversight of start-up and clinical responsibilities—from site identification through to database lock • Ensure start-up and clinical project plans address identified risks while adhering to professional standards, SOPs, client, and regulatory requirements • Proactively identify and address start-up and clinical project, financial, and quality risks • Responsible for financial aspects of clinical and start-up activities, including revenue forecasting • Ensure project team awareness and tracking of Key Project Indicators (KPI) • Develop and implement the site activation and recruitment strategy in collaboration with project teams • Lead and oversee site identification and site selection • Oversight of Informed Consent Form development and translations • Oversight of essential document creation and collection • Lead the end-to-end process of regulatory/ethics committee submissions and approvals • Ensure clinical supplies are in place as applicable • Manage operational aspects to support subject recruitment and retention • Ensure inspection-readiness through quality oversight of TMF, monitoring reports, protocol deviations and issue management • Foster effective communication and collaboration with clients and cross-functional project teams in a global environment.

Role Description Edison Scientific is currently recruiting a Biostatistician Consultant for a flexible, part-time advisory role. In this capacity, you will act as a domain authority, establishing the primary benchmark for AI-driven statistical results to ensure our system delivers outputs that are technically sound, meet regulatory standards, and reflect the latest requirements from governing agencies. This engagement is designed to fit around existing commitments, at approximately 5–20 hours per week. - Knowledge sharing about "day-in-the-life" as an expert working with data in these domains to assemble regulatory submissions. - Describing common tasks or problems where AI could be of value in your workflows. - Identify + describe internal pharma systems that are commonly used for standard workflows. - Generate or review reference ground-truth artifacts to evaluate against - reports, data files, modules, etc. - Identify + add realistic sources of variance or data corruption in study data. - Identify and correct discrepancies in data quality. Qualifications - 10+ years of experience in biostatistical applications within biotech or pharma, preferably at a sponsor. - Graduate degree (Ph.D. preferred) in Statistics, Biostatistics, or a similar discipline. - Proven expertise in crafting SAPs, determining sample sizes, and designing early-phase (I/II) clinical trials. - Deep familiarity with ICH guidelines and FDA regulatory standards, including direct experience with CSRs and IND filings. Benefits - Remote/US based. - Flexible hours / flexible time zone - 5-20 hours per week. - Competitive salary and equity. - Full healthcare coverage — we pay 100% of premiums for you and your dependents. - Support for growing families, including a yearly new parent stipend and fertility coverage through Carrot. - Mental health support through Rula, our in-network therapist and psychiatrist network with fast availability. - 12 weeks of paid parental leave for maternity, paternity, and adoption. - Pet care support with a yearly employer-funded stipend for your animal companions. - Commuter benefits so you can pay for transit and parking with pre-tax dollars. - 401(k) company matching. - $300 health and wellness benefit quarterly. - Lunch is on us every day you're in the office, and dinner is on us when you're working late. - Regular team offsites and company events. - A fast-moving, mission-driven culture where smart people do their best work and actually enjoy doing it.

Role Description As a Senior Clinical Monitoring Lead, you will play a pivotal role in leading the clinical monitoring function within assigned studies to ensure high-quality trial execution and regulatory compliance. You will oversee Site Managers and Clinical Trial Coordinators, ensuring effective monitoring of clinical sites, adherence to ICH-GCP and SOPs, and timely resolution of study issues. Your leadership will support operational readiness for inspections, data integrity, and consistency across all monitoring activities. In larger or complex clinical trials, you may provide operational leadership over Clinical Monitoring Leads, ensuring that all clinical monitoring functions align with the overall project goals. By bringing your expertise and dedication, you will contribute significantly to the success of our clinical trials and the broader business objectives. What You’ll Do - Lead and manage Site Managers in all aspects of site monitoring, including site selection, initiation, routine monitoring, and close-out. - Review monitoring visit reports and follow-up letters for accuracy, completeness, and compliance with protocol, SOPs, and regulatory requirements. - Ensure consistent application of risk-based and centralized monitoring strategies across studies. - Track and report on site performance, enrollment, data quality, and issue resolution. - Ensure timely and accurate documentation in the Trial Master File (TMF) and support audit and inspection readiness. - Partner with Quality Assurance to conduct root cause analyses and implement corrective and preventive actions (CAPAs). - Supervise, coach, and mentor Site Managers, conduct performance reviews, and support professional development. - Deliver training to Site Managers on protocol requirements, therapeutic area knowledge, and monitoring best practices. - Collaborate with CTDU, CTAU, and other stakeholders to align on trial execution operational strategies. - Act as a subject matter expert on monitoring execution for internal and external partners. - Manage all aspects of monitoring operations and quality for allocated studies, ensuring compliance with ICH GCP and applicable local regulations. - Contribute to the development of clinical tools and documents. Qualifications - Bachelor’s degree in life sciences, nursing, pharmacy, or related field; advanced degree preferred. - Minimum of 10 years of clinical research experience, including at least 3 years as a CRA. - Minimum of 5 years in CRA management, mentoring, or monitoring oversight. - Strong understanding of ICH-GCP, FDA/EMA regulations, and global clinical trial guidelines. - Demonstrated experience in CRA performance management and inspection readiness. - Excellent organizational, leadership, and problem-solving skills. - Strong communication skills, both written and verbal. - Willingness to travel (20–30%, as required). - Ability to build relationships across the organization and operate effectively in a hybrid or remote environment. - Proven ability to manage multiple tasks of varying complexity within tight timelines and shifting priorities. - Strong leadership skills with the ability to influence and drive performance across clinical trial teams. Preferred Skills - Advanced degree in life sciences or related field. - Experience with global clinical trial management. - Familiarity with advanced clinical monitoring tools and technologies. Benefits - Medical, Dental, Vision, & Life insurances. - Fitness & Wellness programs including a fitness reimbursement. - Short- and Long-Term Disability insurance. - A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31). - Up to 12 company paid holidays + 3 paid days off for Personal Significance. - 80 hours of sick time per calendar year. - Paid Maternity and Parental Leave benefit. - 401(k) program participation with company matched contributions. - Employee stock purchase plan. - Tuition reimbursement of up to $10,000 per calendar year. - Employee Resource Groups participation.