Source Job

• Leads data management activities for phase 1-4 studies.
• Manages and monitors progress with CROs and vendors.
• Reviews protocols for appropriate data capture and eCRF design.

Iovance Biotherapeutics is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, their employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.

• Manage and drive continuous process improvement initiatives.
• Oversee all daily, end to end, clinical trial/patient matching operations.
• Serve as a liaison between trial sites, sponsors, and drive project delivery.

Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for their work and each other.

• Ensure departmental compliance with all applicable global regulations and Sarah Cannon SOPs.
• Establish and lead the clinical operations strategy, setting departmental goals.
• Promote strong cross‑functional collaboration with internal stakeholders.

McKesson delivers products to healthcare providers. Every day, McKesson’s employees deliver products to healthcare providers that make a difference in the care and life of a patient, focused on creating an inclusive environment with strong values.

• Management and operational delivery of the clinical elements within a trial.
• Successful execution of assigned trials and ensuring completion of trial deliverables.
• Identify challenges to study timelines/deliverables and offer creative action plans.

Precision for Medicine is a precision medicine CRO with a uniquely integrated offering to enable the science of precision medicine. They achieve this by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions. They are dedicated to positively impacting the health and lives of patients around the world, particularly in rare diseases and oncology.

• Lead and manage Statistical Programming function.
• Provide technical leadership for regulatory submissions.
• Manage vendor relationships and internal SOPs.

Genetix Biotherapeutics is pursuing curative gene therapies to give patients and their families more days. They embrace innovation and achieve results through cooperation and the integration of multiple viewpoints, with a focus on radical care.

• Develop and report key quality metrics across all clinical programs and trials.
• Ensure compliance with GCP, ICH-GCP, FDA, EMA, PMDA, and applicable regulations.
• Drive inspection readiness at local and global levels.

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Their core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of their business.

• Serve as the study lead programmer for assigned clinical trial(s), and work closely with study statistician, data management, and other functions within the study team to provide statistical programming support as needed
• Review and ensure high quality of Define packages including aCRF, SDTM/ADaM datasets, Pinnacle 21 reports, cSDRG/ADRG, and define XML for assigned clinical trial(s)
• Work closely with Clinical Data Management colleagues to produce systematic data reports to support efficient clinical trial data review and cleaning

Definium Therapeutics is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Founded in 2019, they are continuously expanding their presence and global footprint, searching for patient-centric, intelligent individuals.

• Provides regulatory guidance throughout the clinical development life cycle
• Compile, coordinate and review applications to Regulatory Authorities
• Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees

Precision for Medicine integrates clinical trial execution with scientific knowledge, lab expertise, and data science to improve the speed, cost, and success rate of life-changing therapies. They focus on Oncology and Rare Disease and value employee contributions.