Sr. Clinical Project Manager

Our client is searching for a Sr. Clinical Project Manager to lead overseeing and managing clinical trials for in vitro diagnostic (IVD) assays, from inception to completion, within the Dx platform area. This role involves collaborating internally and with external partners to ensure the successful execution of trials. Managing multiple projects simultaneously, ensuring adherence to budget, scope, and schedule parameters. Functions across various programmatic areas such as Molecular, Immunoassay, or Blood chemistry, coordinating activities across functional groups to maintain high standards of conduct and timely project completion. Upholding best practices including Project Management, Good Clinical Practice (GCP), and regulatory compliance throughout the project lifecycle.

Key Duties:

Lead and manage clinical trial projects, ensuring compliance with GCP and regulatory requirements. Forecast and manage project timelines, resources, and budgets. Identify suitable clinical trial sites and Contract Research Organizations (CROs), and oversee contract development. Develop clinical protocols, Case Report Forms (CRFs), and training plans, facilitating Institutional Review Board (IRB) submissions. Ensure timely initiation, conduct, and closure of clinical trials, including site visits and data management. Contribute to regulatory submissions by preparing clinical sections of necessary reports. Apply appropriate statistical methods for clinical data evaluation and risk assessment. Stay updated on changes in regulatory requirements and contribute to organizational initiatives. Contribute to the development of quality procedures, templates, and tools within the Clinical Operations function.

Other Duties/Physical Requirements:

Ability to perform physical tasks and concentrate on complex issues throughout the workday. Comfortable working with potentially biohazardous materials and adhering to biosafety practices. Qualifications:

Bachelor’s degree in biological sciences required; MS degree preferred. Minimum 7 years of combined experience in Clinical Operations, Medical Affairs, R&D, Regulatory Affairs, or related fields. At least 5 years of experience managing clinical trials, preferably within a sponsor organization. International trial experience and prior experience in regulatory submissions required. Experience in in vitro diagnostics of clinical chemistry and/or infectious diseases preferred. Certifications such as ACRP/SoCRA, RAC, or PMP are advantageous. Competencies:

Highly motivated with strong prioritization skills to meet project deadlines. Effective communication and team management abilities. Proficient in scientific and regulatory writing. Understanding of statistical analyses and clinical laboratory techniques. Thorough knowledge of GCP, human subject protections, and regulatory requirements. Familiarity with international clinical trial regulations and laboratory quality systems. Experience with Clinical Data Management Systems and electronic Trial Master Files (eTMFs). Required Travel: 30%