Jobs at Precision For Medicine

Designs, develops, and delivers training solutions for clinical trial and related functions; manages new-hire onboarding, triages training requests, maintains learning platforms and documentation, and partners with SMEs to maintain role-based curricula and regulatory-compliant training.

Designs, develops, and delivers learning solutions for clinical trial and GxP functions. Manages new-hire onboarding, triages training requests, maintains learning platforms, and ensures regulatory-compliant training records. Partners with SMEs to create role-based curricula and conducts annual reviews to keep training current with regulations and organizational needs.

Designs and delivers learning solutions for clinical trial functions, partners with SMEs to assess needs, coordinates new-hire onboarding, manages learning platforms and training records, triages training requests, and maintains role-based curricula aligned with GCP and regulatory expectations.

Design, develop, and deliver role-based learning programs and onboarding for clinical operations and translational sciences. Act as intake for training requests, maintain learning platforms, ensure regulatory-compliant training records, and collaborate with SMEs and leadership to keep curricula current with GCP and organizational needs.

Designs and delivers role-based learning for clinical functions, coordinates new-hire onboarding, manages training intake and learning platforms, ensures regulatory-compliant training records, and partners with SMEs to maintain curricula aligned with GCP and role requirements.

Lead global quality and compliance for bioservices and companion diagnostic products. Oversee site quality teams, maintain QMS, manage validations, CAPA, complaints, pre- and post-market device activities, regulatory inspections, and cross-functional quality alignment. Provide leadership reporting, training coordination, and support business development and regulatory interactions. Travel up to 30%.

Lead and oversee all laboratory operations for Bioanalysis, Flow Cytometry, and Companion Diagnostics at the Frederick, MD site. Ensure regulatory compliance (FDA, CAP/CLIA, CLSI, ISO 13485), mentor lab heads, drive operational excellence, manage budgets/KPIs, support regulatory interactions and audits, and serve as scientific and client escalation resource.

Lead process improvement, change management, and operational excellence initiatives for clinical study delivery. Design and document processes, support training, implement mitigation plans, build performance metrics and dashboards, coordinate stakeholders, monitor adoption, and drive continuous improvement across the organization.

Lead process improvement and change management initiatives to improve study delivery for sponsors. Evaluate workflows, recommend and implement process changes, run stakeholder communications, develop documentation, metrics and training, monitor adoption and risks, and support cross-functional operational excellence.

Lead process improvement and change-management initiatives within a CRO/pharma operations group. Evaluate workflows, design and implement business processes, drive adoption, document procedures, develop training, measure performance, and coordinate stakeholders to ensure operational excellence.

Lead process improvement, change management, and operational excellence initiatives for clinical study delivery. Evaluate workflows, design and document new processes, manage stakeholder communications, mitigate operational risks, develop KPIs and dashboards, support training and adoption, and track performance to ensure sustained operational improvements across the organization.

Lead process improvement, change management, and operational excellence initiatives across clinical study delivery. Evaluate workflows, drive root-cause analysis, design and implement process changes, create documentation, train teams, monitor adoption and metrics, and communicate progress to stakeholders with minimal oversight.

Lead process improvement, change management, and operational excellence initiatives for study delivery in a CRO/pharma setting. Evaluate workflows, implement process changes, manage stakeholder communications, measure performance via KPIs and dashboards, document processes, provide training, and support adoption and mitigation of operational risks.

Lead site contract management for clinical studies across Europe: draft, review, negotiate site CTAs and budgets, establish processes and metrics, coordinate execution, advise study teams and sponsors, resolve escalations, maintain contract files, and mentor other SCMs to meet timelines and compliance.

Manage and mentor Site Start Up (SSU) personnel, ensure adherence to SOPs/GCP, oversee training, resourcing, budgeting and compliance, support hiring and onboarding, develop processes and standards, provide performance feedback and conduct reviews, and participate in internal initiatives. Occasional travel may be required.

Lead statistical strategy across clinical development: design consultation, protocol and SAP authorship/review, sample size and randomization oversight, review analyses and clinical study reports, support regulatory submissions and DMC reporting, serve as SME, mentor statisticians, and coordinate with sponsors and vendors for complex programs.

Lead statistical strategy and execution across clinical development, including study design consultation, sample size and SAP authoring/review, regulatory submission leadership, DMC reporting, mentoring statisticians, and partnering with sponsors and vendors on complex programs.

Provide operational support to clinical study sites and project teams across LATAM, ensuring compliance with ICH-GCP and local regulations. Manage essential documents, site communications, CTMS/EDC entries, investigator site files, and logistics for samples and study supplies. Assist with site recruitment, monitoring activities (remote and occasional on-site), data review, and study close-out tasks while escalating risks and supporting investigators and internal project teams.

Lead and execute GCP process audits, internal and vendor assessments, investigator site and TMF audits; support QA systems (SOPs, CAPA, training), computer systems validation, sponsor/client audits, regulatory inspections, and provide QA consultation to project teams to ensure compliance with GCP/ICH and FDA.

Lead and execute GCP process audits and quality oversight across clinical studies. Maintain QMS (SOPs, training, CAPA), manage vendor/site/TMF/internal audits, support regulatory inspections, participate in computer system validation and change control, provide QA consultation to project teams, and monitor quality metrics and corrective actions to ensure compliance with GCP/ICH and FDA regulations.