Clinical Study Manager, Global Development Operations

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%)