Position Purpose:

The Incumbent will serve as a clinical representative for assigned projects. In association with his/her immediate supervisor, the Incumbent will manage the development and implementation process of Leadiant clinical operation services involving the Product Development department or cross-functional teams focused on the delivery of new or existing projects. The Incumbent will be responsible for training and supervising study staff assigned to the projects. The Incumbent will proactively monitor projects from concept through completion. The Incumbent will organize and coordinate interdepartmental and outside vendor activities ensuring completion of the projects on schedule and within budget constraints to achieve success of the goals set forth at all stages in the clinical process. The incumbent will also ensure compliance with applicable Leadiant standard operating procedures (SOPs) and GCP guidelines, as well as Federal Regulations.

Daily Responsibilities For Assigned Projects:

  • In collaboration with department leads, manage the progress of clinical studies
  • Assure clinical study conduct is in compliance with Leadiant SOPs, Good Clinical Practice Guidelines and federal regulations governing the conduct of clinical studies
  • Works with department leads to maintain projects within intended timelines and projected budgets
  • Identifies issues affecting study conduct and work with department leads on satisfactory resolution
  • Develops requests for proposal (RFP) and coordinates the selection of CROs and outside vendors
  • Manage outside vendors and contractors
  • Tracks key project metrics and action items
  • Tracks progress of all clinical study activities, including regulatory compliance, site selection, enrollment, site monitoring, drug supply, adverse events/serious adverse events, data management, biostatistics, and medical writing
  • Oversee and assist with the development of study protocols
  • Development of study timelines and budgets
  • Track vendor and site payments
  • Develop and/or coordinate the development of documents in support of clinical studies (CRFs, ICFs, manuals, etc.)
  • Oversee the development and setup of activities for clinical management, monitoring, Trial Master File maintenance, data management, biostatistics, and medical writing
  • Work with internal departments and external vendors to establish appropriate study processes to ensure compliance with guidance documents and regulations
  • Report progress of clinical projects to management
  • Participate in the development, review, and approval of vendor agreements and budgets
  • Assess training needs for clinical project staff; conducts and documents training of team members as appropriate
  • Oversee study activities by Leadiant staff, vendors, and contractors
  • Support site management and monitoring efforts as needed
  • Monitoring of select sites to assure protocol and GCP compliance
  • Participate in the development, review, and maintenance of clinical operations SOPs
  • Responsible for training and supervising study staff
  • Assist in the management of the clinical operations team
  • Assist in preparing clinical documents for regulatory submissions
  • Mentor and train junior level team members
  • Serve as a day-to-day line manager for junior level team members
  • Participate in cross-functional team meetings, represent the clinical department, and provide clinical operations updates
  • Other duties as assigned

Basic Qualifications:

  • RN or Bachelor’s degree within a health/biomedical sciences field, or related field and equivalent experience
  • 6+ years of experience in working in clinical research
  • 4+ years of experience monitoring and/or managing clinical studies in the pharmaceutical industry or at a CRO
  • Experience in managing multi-center study set-up and execution in multiple therapeutic areas preferred
  • Knowledge of GCP, ICH guidelines and US FDA regulatory requirements for the conduct of clinical trials required
  • Strong critical thinking skills
  • Strong ability to prioritize and organize workflow activities in a fast-paced environment
  • Ability to work effectively in team settings and manage staff
  • Proficient in basic computer programs such as MS Office Suite and MS Project
  • Excellent communication skills; ability to tactfully communicate sensitive information
  • Demonstrated leadership skills
  • Ability to work independently and in a cross-functional team environment
  • Demonstrated high-level planning and organizational skills
  • Demonstrated ability to generate creative solutions to complex problems
  • Manages outside vendors and contractors
  • Understanding of clinical development, regulatory, QA, CMC, clinical trials, and project management methodology
  • Understanding of basic protocol design and ability to implement/conduct phase I-IV clinical studies from start-up through closeout
  • Previous experience as a clinical research associate
  • Experience with budget and timeline management
  • Experience in drafting monitoring plans, risk plans, and other internal documents needed for study start-up and management
  • Experience in successfully participating in audits/inspections of assigned studies
  • Ability to travel at least 20% of the time
  • Ability to adapt to changes in the work environment
  • Demonstrates accuracy and thoroughness

Apply Here

Leadiant Biosciences, Inc. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, and other legally protected characteristics. The EEO is the Law poster is available here: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.

If you need a reasonable accommodation because of a disability for any part of the employment process, please send an e-mail to Jobs@leadiant.com and let us know the nature of your request and your contact information.