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Senior/Clinical Trial Manager

LOCATION: South San Francisco

DEPARTMENT: Clinical Operations

DIVISION: Product Development

REPORTS TO: VP, Clinical Operations

SUMMARY:

The Clinical Trials Manager is accountable for the day to-day operational oversight of at least one clinical trial in all Regulatory phases, including trial start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements. This activity included management of one or more Clinical Research Organization (CROs)/vendors.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Manages clinical operations trial activities for at least one clinical trial
  • Responsible for overall study project management of a clinical trial(s) including:
    – Projection and management of study timelines
    – Creation and management of clinical trial budgets, in conjunction with line manager
    – Ensures timely reporting of study metrics to Day One line and/or executive management
    – For outsourced studies, manages the CRO and any supportive vendors
  • Serves as primary contact for the CRO, and functional area representatives involved with the trial execution
  • Facilitates Day One cross-functional study management team (SMT) meetings, responsible for the timely setting of agendas, effective conduct of SMT meetings and timely issuance of meeting minutes
  • Maintains regular internal contact with relevant departments such as Regulatory Affairs, Drug Safety and others as necessary.
  • Attends study-related meetings, including vendor selection, project kick-off, CRO project meetings, functional area-specific meetings, and Investigator meetings
  • Ensures investigators and site coordinators are appropriately trained for the study, and that documentation in this regard is collected and filed
  • Visits the CRO and ancillary vendors as needed
  • Ensures proper training of the CRO and supporting vendors on the protocol
  • Reviews and approves site monitoring visit reports in accordance with the study Monitoring Plan; escalates risk findings according to the Study Plan or Issue Escalation Plan
  • Monitors CRO performance to assure protocol compliance and escalates at-risk findings according to the Study Plan or Issue Escalation Plan
  • Assists in the selection and initiation of sites
  • Provides problem-solving expertise with study monitors; tracks key performance indicators of GCP/study compliance and develops corrective action plans as required
  • Visit clinical sites during the course of the study as necessary
  • Provides input for definition of new or revised process development, problem solving, training, etc., as needed
  • May manage or be involved in Clinical Operations, Medical Affairs (including Expanded Access Programs or Investigator-Sponsored Trials), or Product Development projects
  • Mentors and manages junior clinical operations staff, as applicable
  • May attend qualification, initiation, interim monitoring, and close-out visits.
  • Occasional domestic US travel up to 25%, and internationally (on an “as needed basis”) in support of trial activities
  • Performs all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, and appropriate industry, FDA, ICH guidelinesand Good Clinical Practices

SUPERVISORY RESPONSIBILITIES:

  • Clinical Trial Specialist, or Clinical Research Associate

 

EDUCATION/EXPERIENCE/SKILLS:
Education:

  • BS/BA degree in related discipline; or,
  • Advanced degree in related discipline; or,
  • Certification in assigned area

 

Experience:

  • Typically requires a minimum of six (6) years of related experience, contingent on education/training
  • Minimum three (3) years’ experience in study management is preferred, or equivalent experience gathered in a previous clinical trials management role
  • Oncology experience is required
  • Experience as a Clinical Research Associate is preferred

 

Knowledge/Skills/Abilities:

  • Extensive clinical operations knowledge and cross-functional understanding of clinical trial methodology
  • Exhibits ability to learn and apply foreign regulations to the clinical trial/research process
  • Experience developing trial plans including, site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management
  • Knowledgeable in clinical database platforms, interactive response technology (IRT) applications and processes, and clinical supply logistics
  • Oncology therapeutic area knowledge essential
  • Knowledgeable in Good Clinical Practice requirements and their application to the conduct of clinical studies in the United States and internationally
  • Organizes and prioritizes numerous tasks and completes them under time constraints
  • Frequently applies strong analytical, business and communication skills, as well as technical standards, principles, theories, concepts and techniques
  • Strong organizational and analytical skills are required
  • Demonstrated success in problem solving
  • Experienced professional with a full understanding of area of specialization
  • Good communication skills both oral and written are a must
  • Working knowledge of MS Word, Excel, and PowerPoint is required, and applications as needed for the position
  • Develops solutions to routine problems of limited scope
  • Detail-oriented
  • Ability to work either independently or in a team environment

 

JOB COMPLEXITY:

  • Works on assigned problems of moderate scope with analysis of situation or data required
  • Exercises judgment within defined procedures and practices to determine appropriate action
  • Builds productive internal and external working relationships
  • Uses professional concepts and  company’s policies and procedures to solve a variety of routine problems.

 

DISCLAIMER:
The preceding job description has been designed to indicate the
general nature and level of work performed by employees within
this classification. It is not designed to contain or be interpreted as
a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

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