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Scientific. Clinical. Software Engineering

Clinical Operations Manager

New Jersey All, NJ

Job Type: Clinical Job Number: JN -042020-26663 Region: New Jersey All

Job Description

Summary:

  • Responsible for the overall management and oversight of clinical trials from start up through CSR, including but not limited to: development of project documentation, training project staff, monitoring study progress, assessing protocol adherence, administration and oversight of study budgets, management of CROs and third-party vendors for clinical services, management of project timelines and deliverables

Responsibilities:

  • Manage all operational aspects for implementation of clinical trial activities from study start-up through database lock
  • Serves as the leader for the management and execution of all clinical trial activities in compliance with GCP and relevant regulatory guidelines
  • Effectively manages the cross-functional study team to achieve deliverables with high quality, on time and within budget through information-sharing, ongoing study team meetings/discussions and ensuring effective risk management planning
  • Manage study-related service providers and serve as the primary point of contact for contracted CROs; identifying potential risks and resolving issues with CROs
  • Identifies scope of work, study contracting needs, CRO selection process, provides input into vendor management plan, and monitors study metrics to ensure quality and performance standards are met
  • Develops and manages detailed project plans and provides regular study status updates to senior management
  • Prepares and manages the budget/financial plan including overall study and site-level costs, collaborating with the respective stakeholders in contract negotiations and preparation, payment schedule and tracking
  • Identifies key milestones and tracks critical study activities, issues and strategic priorities
  • Reviews study data listings for accuracy, discrepancies and formatting throughout the study
  • Leads clinical operational team meetings in support of the respective clinical trial including: drafting agenda, collecting minutes, tracking action items, providing ongoing status of trial enrollment and timelines, outlining vendor related deliverables, communicating risk/issues, and managing input from other internal and external partners
  • Serves as the clinical operations representative on team meetings held by other functions and provides necessary input into key process related documents
  • Provides coaching/mentoring to assigned project staff (CRAs, CTAs) by demonstrating leadership competencies
  • Participates in the development and review of department SOPs and process improvement initiatives

Requirements:

  • Bachelor s degree in the life sciences, healthcare or related field
  • A minimum of 5-7 years of clinical project management experience within the pharmaceutical/biotechnology industry, managing the logistics of clinical trial execution
  • Oncology trial management experience
  • Experience leading the development and implementation of risk management plans, managing study budgets and resourcing plans
  • Demonstrated experience managing CROs and other specialty vendors is essential
  • Thorough understanding of the drug development process and clinical trial execution, including ICH/GCP requirements and local regulations
  • Excellent written and oral communication skills, as well as conflict management, time management and organizational skills
  • Proficiency with and ability to utilize software applications that support Clinical Operations: Microsoft Word, Excel, PowerPoint; Adobe Acrobat, EDC systems, etc.

Must possess:

  • Desire to work for a smaller company
  • Require occasional off-hour meeting with global teams
  • Experience managing the full life-cycle of a study from study set up, study start, execution and close out
  • Effective leadership skills to lead cross-functional teams across time zones
  • Initiative and accountability
  • Effective team work and interpersonal skills (globally, internally and externally)
  • Good decision-making, judgment, and problem solving skills
  • Excellent oral and written communication skills
  • Ability to embrace change and comfortable with ambiguity


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