ul>Partner with IT and internal clinical business operations resources to support the strategic lifecycle of TMF including, but not limited to, version releases, system updates, validation or user acceptance testing, and integrations with other clinical applications through change management .
SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ.
Morris Plains, NJ17 days ago
Role Summary: The Clinical Pharmacist role reports to the Cigna Pharmacy Clinical Program Support team with a primary focus on delivering on clinical research, drug formulary maintenance and regulatory responsibilities aligned to the Cigna Healthcare US Employer formularies. These states include: Alabama, Alaska, Arizona, Arkansas, Delaware, Florida, Georgia, Hawaii, Idaho, Iowa, Kansas, Maryland, Massachusetts, Michigan, Nebraska, Ohio, Pennsylvania, Texas, Utah, Vermont, and Washington State.
CPM will assist in all areas of conducting a clinical research program and maybe responsible for the conduct of specific aspects of a clinical program including but not limited to: developing the clinical trial strategy, timelines, forecasting, managing the overall study budget, developing risk management / contingency plans for minimizing impact on project objectives, site selection and management, monitoring, coordination of clinical data management, data analysis functions, and CRO and Vendor selection and management. Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand.
Morristown, NJ30+ days ago
p>The position combines strong digital and AI domains with function-level business and transformation leadership, requiring the ability to produce decision-grade insights for CSO leadership, translate complex technology and regulatory constraints into strategic value hypotheses, and steer outcomes across highly matrixed, regulated environments. Direct and validate: Competitive and technology intelligence to inform strategic positioning, function-level business needs and value hypotheses, prioritization of business-driven requirements shaping product and roadmap decisions & gaps analysis against existing solutions and operating models.
Franklin Lakes, NJ14 days ago
p>Working within the Medical Affairs organization, the Senior Clinical Project Manager (Specimen Management) is responsible for clinical trial management of multiple studies and may be subject matter authority for group or platform of assigned clinical studies including the planning, implementation, oversight, project management and completion of clinical trials conducted by Medical Affairs or Contract Research Organizations (CRO). Works without appreciable supervision and direction, Prepares and/or reviews study-related or essential study start-up documents as they relate to the assigned clinical trials (e.g., Clinical Protocols, Informed Consent forms, Monitoring Plan, Clinical Product Management Plan, Clinical Safety Management Plan, Case Report Form (CRFs), CRF Completion Guidelines and other relevant documents).
Franklin Lakes, NJ4 days ago
p>Clinical Project Manager serves as a study and project manager for studies of moderate to high complexity from protocol development through study conduct and study closeout in compliance with Good Clinical Practices, and all National and Local Regulations. Manages essential study documents, maintains the trial master file, supports approvals, and leads final study reporting and closeout activities for complex trials.
li>Performs study procedures (e.g., obtain ECG recordings, vital signs, safety assessments, etc.) as required by study protocol under the supervision of the Clinical Research Coordinator, Principal Investigator, and Sub-Investigators. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Morristown, NJ30+ days ago
p>Experience / Skills: MD or MD/PhD in a relevant scientific discipline, preferably pulmonology, with at least 2 years relevant experience in clinical development within the pharmaceutical industry, academia, or government agencies such as the NIH, FDA, or other equivalent national or international public health and regulatory organization.
On Clinical Development, the CRD:
Parsippany, Georgia19 days ago
div>In this remote role you will serve as the primary country-level leader for clinical trial delivery, ensuring studies are executed efficiently from start-up through closeout. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time).
Parsippany, NJ29 days ago
li>Collaborate with Ferring clinical operations, TA medical directors, and CRO to identify and develop key performance indicators (KPIs) for activities aimed at enhancing trial recruitment, and ensure reports are developed and shared with management to track progress and drive improvements.
Report identified site or vendor issues to Clinical trial team via TA medical directors including opinions and observations related to the operational, scientific and other aspects of the study so that Ferring clinical operations team can assess appropriate trial-related actions.
Parsippany, NJ30+ days ago
p>• Manages the contract negotiation process across the entire life cycle including RFI vendor identification RFP vendor selection decision contracting negotiation performance monitoring change orders and ensures proper closeout of agreements to maximize contract value and achieve target savings. As part of our rapidly growing science-driven organization colleagues at Gilead are revolutionizing healthcare by bringing urgently needed medicines to patients in the areas of Virology Inflammation and Oncology conditions.
Neptune, New Jersey19 days ago
li>Ensures timely, accurate, and reliable documentation, tracking, and reporting of all required clinical trial study and patient data and metrics through routine collaboration with all research team members including but not limited to Investigators, Clinical Research Nurses, Clinical Research Coordinators, Regulatory and Study Start-Up Specialists, Clinical Data Coordinators, Study Contract and Finance Staff, Sponsors and Contract Research Organizations, and other team members throughout the HMH Network as required. Focuses on continuous process improvement strategies both within the assigned Research Program or Division and throughout the entire HMH Research Enterprise, always seeking opportunities for streamlining and/or accelerating accruals to clinical trials, data cleaning, data quality, and trial completion.