Clinical Study Manager, Global Development Operations

Location
South San Francisco, CA
Posted
Jul 27, 2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Purpose:

  • Support the design and manage operational activities related to the planning, implementation and reporting of clinical trials at a study level/across multiple studies according to Good clinical practice (GCP) and Theravance Standard Operating Procedures

Context & Responsibilities:

  • Manage and co-ordinate clinical study design and implementation at a program and functional level according to Good clinical practice (GCP) and Theravance Standard Operating Procedures
  • Provide leadership and support for clinical studies at Theravance Biopharma
  • Responsible for operational input and oversight in designing, planning, initiating and completing clinical trials across a program(s)
  • Expected to take the lead in writing clinical documents including study protocols, investigator’s brochures, and clinical study reports
  • Lead clinical study and cross functional team to make key decisions related to strategy and issue resolution
  • Manage study budget, timelines, insourcing and outsourcing partners to required standards
  • Mentoring and training and career development of staff

Key Activities:

  • Review and provide input for operational sections at a study level/across multiple studies for study related documents including SCD, Protocol, Study Plans, CSRs, Safety related documents
  • Work with project manager to develop study timelines and ensure cross functional adherence
  • Contribute to execution of feasibility process and selection of sites per study plan
  • Develop with finance site budget template and approve budgets according to parameters
  • Organize and where appropriate lead investigator, study coordinator, and CRA training meetings
  • Author Site Evaluation Visit Plans
  • Coordinate cross-functional review of escalated issues from sites or other departments
  • Oversee identification, selection, set-up, management , and relationship of vendors
  • Approve vendor SOW , invoices and manage budget
  • Contribute to the study level forecast for investigational product and comparators
  • Ensure timelines and deliverables are communicated appropriately
  • Monitor the execution of the clinical study against timelines, deliverables and budget
  • Identify barriers to enrolment and develop solutions, recruitment plans
  • Monitor and act upon data flow metrics
  • Provide updates regarding budgets and obtain approval for budget deviations
  • Communicate study status to management
  • Review and approve monitoring visit  reports
  • Review CRF data, query trends and work with data management and stats to develop risk mitigation plans
  • Execute Inspection Readiness activities
  • Supervise direct reports , provide performance management opportunities for career development, conduct performance reviews where relevant
  • Participate in cross-functional task forces or work streams for process improvements

Key Output:

  • Study related documents, plans and status reports
  • Author, Protocol , Amendments and ICFs
  • Cross-functional Study Specific training
  • Investigator, Coordinator and CRA training meetings
  • Site Selection and Approval
  • Vendor Management
  • Monitoring Report Approval
  • Budget development and approval

Decision Authority:

  • Operational aspects at a study level/across multiple studies
  • Study budget as appropriate
  • Scope of Work for selected vendors
  • Study feasibility content
  • Content of study specific plans and documents
  • Site selection

Basic Qualifications:

Combination of degree and relevant Biopharma related experience within a pharmaceutical, biotech environment or relevant CRO:

  • Doctorate degree & 2 years of directly related experience

OR

  • Master’s degree and 4 years of directly related experience

OR

  • Bachelor’s degree and 6 years of directly related experience

AND

  • 4 years direct experience in a Clinical Operations related function/role

Preferred:

  • BS/BA/BSc in the sciences or RN
  • 6 years’ work experience in life sciences or medically related field, including 5 years of supporting biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a pharmaceutical, biotech or CRO company)
  • 2 years line management experience.

Experience:

  • Phase experience based on role
  • Experience in Financial management of studies
  • Experience participating in Clinical Operations related projects with cross-functional stakeholders
  • Experience on Clinical Operations related activities within a matrixed team
  • Participation/engagement in Influence/Negotiation at Study Level/Project Level
  • Managing Suppliers at a Study Level
  • Participating in contract negotiations with suppliers
  • Understand Inspection Readiness/Regulatory considerations for their role

Core Competencies:

  • Good Clinical Practice (GCP), ICH, and Regulatory requirements
  • Teamwork
  • Study Leadership
  • Project Management
  • Effective People management
  • Scientific and Technical excellence
  • Strong written and verbal communication
  • Problem solver, presents solutions to issues
  • Self-Motivated
  • Knows when to escalate to senior management
  • Ability to address conflict management
  • Ability to maintain a calm, professional demeanor despite demanding deliverables
  • Flexible, team-oriented

Travel:

  • Some travel may be required (<20%)