Biotech/Pharmaceutical

Sr. Study Manager, Clinical Operations – Remote

Permanent

Penfield Search Partners

Contact: Linda Aronova – laronova@penfieldsearch.com

Job Description: The Senior Study Manager, Clinical Operations will be responsible for all aspects of global clinical trial operations from planning to execution and data delivery and will oversee multiple clinical trials.  This position can be performed remotely anywhere in the United States, with the exception of Colorado and New York, NY and will report into our New Providence, New Jersey office.  

  • Coordinate and manage all aspects of domestic and international trial(s) from study start-up through close-out in accordance with ICH-GCP and other applicable local regulations. This includes responsibilities to actively collaborate within clinical operations, as well as, with cross functional internal and external team to ensure timely delivery, budget implementation and clinical trial results.
  • Manages multiple clinical trials and identifies resource and budget requirements across assigned trials.
  • Directs oversight of strategic partners, including CROs and other vendors, to ensure study plans, timelines, and budgets are aligned with research objectives and standards and corporate goals
  • Lead the study team using strong project management skills and participate on cross functional teams as needed for assigned product.
  • Develops study management plans that include enrollment and other key study milestones, risk identification and mitigation, financial oversight, communication, monitoring, and other study plans
  • Ensures execution to deliver trial(s) on time, within budget and with high quality
  • Reviews of CRO and other third-party vendor trial performance metrics, budget and timelines to ensure that work is performed in accordance with the scope of work and study management standards
  • Assists with the development and authoring of clinical trial documents and manuals, including but not limited to Protocols, Informed Consent Forms, Case Report Forms, and other study and regulatory documents
  • Oversees country and investigational site feasibility activities and selection of investigative sites
  • Leads study team(s) to successfully achieve various data deliverables and study related milestones
  • Performs study-related training with CRO, vendor and investigational sites, as required
  • Functions as the primary contact for the studies between Clinical Operations and other departments and provides study status updates and reports, as required
  • Leads or participates in project team meetings, Investigator Meetings and other relevant business matters
  • Leads the study teams through the identification of potential clinical risks for study success and coordinates plans for mitigation while monitoring triggers and communicating plans to throughout the study
  • Support internal/external audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate e.g., investigational sites, vendor management, etc.
  • Oversee and coordinate study drug projections and forecasting, authoring pharmacy manual, IRT development and UAT with clinical supplies representative.
  • Ensures assigned study Trial Master file is complete and inspection ready. Participates as a member of working groups to improve the efficiency, effectiveness and quality of Clinical Operations and alignment of ancillary departments with development and input on policies and SOPs. Ensure the study is “audit ready” at all times.
  • Ensures adherence to Good Clinical Practice and all applicable local and international regulations

Qualifications:

  • Minimum BS/BA degree or equivalent in Nursing, Life Sciences, Pharmacy or science related field
  • Minimum of 6 years of experience in the biopharmaceutical industry or other relevant clinical research experience in drug development and the conduct and management of multinational clinical trials
  • Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience.
  • Ability to effectively manage multiple priorities across several trial activities and protocols , under minimal supervision.
  • Experience in executing a wide range of clinical trial activities (from start-up to clinical study report), including CRO management and project management
  • Willingness to travel 10-20%
  • Oncology experience preferred
  • Excellent experience working in a cross-functional global setting, strong cooperative team player, ability to be flexible and adapt to a changing and complex environment.
  • Strong computer skills using Word, Excel, Outlook, PowerPoint, and MS Project (preferred)

Tagged as: Sr. Study Manager, Clinical Operations - Remote