Associate Director of Clinical Operations

5 days ago

Bethesda, United States Piper Companies Full time
Job DescriptionJob Description

Piper Health and Sciences seeks a highly experienced and strategic Associate Director of Clinical Operations (Hybrid) to join a leadership team at a well-established research organization in Bethesda, MD. The Associate Director of Clinical Operations will be a senior leader responsible for overseeing and advancing our centralized monitoring processes, ensuring efficient and compliant clinical operations.

 

Responsibilities of the Associate Director (AD) of Clinical Operations:

  •  Lead and oversee centralized monitoring activities across clinical trials.
  • Ensure effective implementation and maintenance of centralized monitoring processes, including Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs).
  • Develop and present proposals for new clinical trials.
  • Participate in bid defense meetings to secure new projects.
  • Collaborate with cross-functional teams to design and plan clinical studies.
  • Ensure study designs are robust, compliant, and capable of meeting regulatory requirements.
  • Oversee the management and maintenance of Trial Master File (TMF) and Clinical Trial Management Systems (CTMS).
  • Prepare and present reports to senior management on clinical operations performance, including centralized monitoring metrics and study progress.
  •  Manage and oversee various clinical operations functions, including clinical project management, clinical site management), and clinical systems management.
  • Ensure proactive identification and mitigation of risks through centralized monitoring.
  • Review clinical trial protocols to ensure they align with centralized monitoring and reporting requirements.
  • Provide technical guidance and oversight for central monitoring activities.

Qualifications of the AD of Clinical Operations:

  • 10+ years of experience working in clinical operations with extensive experience in centralized monitoring
  • 5+ years of experience in a Senior Leadership position, providing oversight to various teams
  • Bachelor’s degree or Advanced degree (Master's or Ph.D.) in a related field (e.g., life sciences, clinical research).

Benefits of the AD of Clinical Operations:

  • Salary: Between $155,000 - $175,000 annually based on years of relevant experience
  • Full Benefits, Paid Time Off (PTO), Paid Holidays and hybrid work flexibility

 

Keywords:

Associate director, executive director, director, associate director of clinical operations, clinical operations, clinical project management, CPM, senior leader, centralized monitoring, CRO, clinical research organization, industry, biopharmaceutical, biotechnology, sponsor, investigator initiated, oncology trials, infectious disease, cardiology, study start up, on site monitoring, interim monitoring, regulatory, clinical trial studies, TMF, trial master file, CTMS, clinical trial management system, clinical trial protocols, SOP, proposal writing, bid defense, study activities, regulatory requirements, FDA, GCP, ICH, good clinical practice, technical writing, risk-based, quality management, study design, hybrid, clinical research, senior management, senior manager

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PandoLogic. Keywords: Clinical Research Director, Location: Bethesda, MD - 20810 , PL: 595539367

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