Senior Clinical Project Manager (Remote)

  • Galderma Laboratories
  • Remote * (Bridgewater Township, NJ, USA)
  • Apr 16, 2021
Healthcare Management Project Management Telecommuting

Job Description

Company OverviewGalderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetics solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit DescriptionThe Senior Clinical Project Manager plans and manages overall clinical operations for assigned global clinical trials/programs. This includes timelines, budgets, resources, investigational sites, vendors and key project deliverables. This position ensures compliance with SOPs, Regulatory requirements and ICH/GCP guidelines and aligns with Strategic & Innovation Group (SIG) strategies and goals. The Senior CPM may lead or mentor other CPMs in the organization.Job ResponsibilitiesPlan and Conduct Clinical Studies Lead and manage multidisciplinary Clinical Trial Teams to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices. Serve as the primary contact with CRO and act as team leader of the study work group. Manage Subcontractors Work with outsourcing manager to prepare clinical outsourcing specifications. Participate in the selection of CRO. Quality and Process Contribute to and initiate process improvement initiatives. Budget and Planning Establish project milestones, budget and timelines for the study in partnership with the study team and outsourcing manager. Project Team Representative (PTR) Participate in the overall project planning and optimization with the Project Team. Work closely with the Medical Experts and Clinical Scientist for the design of the clinical trials within the program. Other duties as assigned. Minimum Requirements Bachelor's degree, preferably in a biologic/scientific discipline is required. Minimum of 7 years progressive experience in clinical operations including 5 years of clinical project management or equivalent with pharma, biotech and/or CRO is required. Systemic route of administration clinical trials experience required; pediatric, drug/device combination and biologics experience preferred. Thorough understanding of country-level regulations, ICH and GCP guidelines, cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs. Vendor management experience preferred. Travel is estimated at 30%. Other Important InformationEmployer's Rights: This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based upon your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not a contract for employment, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.