Clinical Study Manager, Global Development Operations
- Employer
- Theravance Biopharma
- 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%)