What are the responsibilities and job description for the (Sr.) Country Study Manager position at Roche?
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The Position
This Opportunity
Who you are
University degree or equivalent, professional qualification preferably in a medical/science-related field and experience demonstrating knowledge and understanding of clinical trials. Clinical trial project management experience is desirable.
For a senior position, at least 2 years’ experience in clinical trial project management. Must demonstrate strong clinical research expertise in the assigned studies, excellent project management skill and communication, interpersonal and networking skills.
Job Required Competencies
Managing Work - effectively manages self-time and resources to ensure that work is completed efficiently.
Monitoring Information - sets up ongoing procedures to collect and review information needed to manage and organization or ongoing activities within it.
Communication - conveys information and ideas clearly and concisely to individuals or groups in an engaging manner that helps them understand and retain the message; listens actively to others.
Work Standards - sets high standards of performance for self others; assumes responsibility and accountability for successfully completing assignments or tasks; self-imposed standards of excellence rather than having standards imposed.
Adaptability - maintains effectiveness when experiencing major changes in work responsibilities or environment(e.g. People, processes, structure, or culture); adjusts effectively to change by exploring the benefits, trying new approaches, and collaborating with others to make the change successfully.
Building Partnerships - develops and leverages relationships within and across work groups to achieve results.
Initiating Action - takes prompt action to accomplish work goals; takes action to achieve results beyond what is required; is proactive.
Earning Trust - gains others’ confidence by acting with integrity and following through on commitments while disclosing own positions; treats others and their ideas with respect and supports them in the face of challenges.
Decision Making - identifies and understands problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information; chooses the best course of action by establishing clear decision criteria, generates and evaluates alternatives, and makes timely decisions; takes action that is consistent with available facts and constraints and optimizes probable consequences.
Influencing - uses effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions that support specific work outcomes.
Technical & Professional knowledge & Skills - has achieved a satisfactory level of technical, functional and/or professional skills or knowledge in position-related areas;, keeps up with current developments and trends in areas of expertise, leverages expert knowledge to accomplish results.
Others - be able to communicate clearly and accurately in both written and spoken English.
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche China consists of the full value chain of Pharmaceuticals and Diagnostics fields, from early research, clinical development, manufacturing to commercialization. With more than 7,000 employees, Roche China is now working to develop itself into Roche's third global strategic center after Basel and San Francisco, and making sustained efforts to fulfill its long-term commitment to China, so as to meet Chinese patients’ unmet needs.
Roche is an Equal Opportunity Employer.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
The Position
This Opportunity
- Provide leadership and regional/local strategic planning and operational delivery of assigned clinical studies through all phases of study management (preparation, study start-up, conduct, close-out), in accordance with Roche quality standards, all applicable regulations, timelines and budget commitments
- Provide clinical trials management, including clinical trial oversight, budget and contract oversight, managing vendors and stakeholders, developing recruitment and site monitoring plans and risk mitigation strategies; performing operational activities from study start-up through database lock: including feasibility, regulatory document management, systems maintenance, site support and vendor management
- Establish long-term, peer-to-peer relationships with investigators, in a given clinical studies and deliver quality interactions and services that bring value to HCPs, and that are aligned with medical strategies
- Has full accountability and oversight for all assigned studies at regional/country/study level in accordance with the overall project plan, manages and maintains accurate country/ study level plans (e.g, timelines, budget, resource, risk and quality plans) in the appropriate Roche planning system
- Highlights deviations and risks in plans to relevant internal and external parties, develops and implements mitigation strategies as required
- Plans and executes country study goals and commitments, and ensures compliance to relevant processes
- Leads local study team, represents Country/Regional Clinical Operations at global SMT, and provides Global Teams with feedback from an Affiliate perspective
- Oversees study feasibility, site-monitoring performance in preparation of study monitoring plan, risk management plan, and ensures TMF/eTMF completeness and oversight of all relevant compliance activities for allocated studies in the study whole period
- Provides study oversight, leadership and support to Contract Research Organization (CRO) staff to ensure overall delivery at the country and site level, and interfaces with local vendor manager CRO management regarding feedback on CRO staff performance as required
- Coaches, and provides indirect line management support in partnership with the relevant line managers to study team members by setting clear goals and expectations, monitoring performance, providing overall motivation, support, training, feedback and follow up to ensure team performance is fully optimized
- Collaborates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and completion of Corrective and Preventative Actions for allocated studies
- Develops and maintains optimal site relationships with key investigator sites and key investigators, alliance partners and /or collaborative groups for current and future Roche studies
- Participates in overall Therapeutic Area support together with the therapeutic leads and country experts(e.g. Landscaping activities, intersigator/site development activities or affiliate cross functional teams, etc.), as required
- For Local/China Single Country Studies, as SMT leader, sets up and maintains an effective high performing local study team by ensuring clarity of roles, responsibilities, accountabilities and deliverables for members
- Perform HGRAC related activities including submission and HGR oversight
- Works with study team to manage the day-to-day activities of study, including EC dossier preparation and study regular trackings, site initiation activities, oversight monitoring status and SMR review, issues and solution tracking, timely and properly issue escalation and tracking of safety distribution/ reconciliation, study finance and IMP management and investigator meeting organization
Who you are
University degree or equivalent, professional qualification preferably in a medical/science-related field and experience demonstrating knowledge and understanding of clinical trials. Clinical trial project management experience is desirable.
For a senior position, at least 2 years’ experience in clinical trial project management. Must demonstrate strong clinical research expertise in the assigned studies, excellent project management skill and communication, interpersonal and networking skills.
Job Required Competencies
Managing Work - effectively manages self-time and resources to ensure that work is completed efficiently.
Monitoring Information - sets up ongoing procedures to collect and review information needed to manage and organization or ongoing activities within it.
Communication - conveys information and ideas clearly and concisely to individuals or groups in an engaging manner that helps them understand and retain the message; listens actively to others.
Work Standards - sets high standards of performance for self others; assumes responsibility and accountability for successfully completing assignments or tasks; self-imposed standards of excellence rather than having standards imposed.
Adaptability - maintains effectiveness when experiencing major changes in work responsibilities or environment(e.g. People, processes, structure, or culture); adjusts effectively to change by exploring the benefits, trying new approaches, and collaborating with others to make the change successfully.
Building Partnerships - develops and leverages relationships within and across work groups to achieve results.
Initiating Action - takes prompt action to accomplish work goals; takes action to achieve results beyond what is required; is proactive.
Earning Trust - gains others’ confidence by acting with integrity and following through on commitments while disclosing own positions; treats others and their ideas with respect and supports them in the face of challenges.
Decision Making - identifies and understands problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information; chooses the best course of action by establishing clear decision criteria, generates and evaluates alternatives, and makes timely decisions; takes action that is consistent with available facts and constraints and optimizes probable consequences.
Influencing - uses effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions that support specific work outcomes.
Technical & Professional knowledge & Skills - has achieved a satisfactory level of technical, functional and/or professional skills or knowledge in position-related areas;, keeps up with current developments and trends in areas of expertise, leverages expert knowledge to accomplish results.
Others - be able to communicate clearly and accurately in both written and spoken English.
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche China consists of the full value chain of Pharmaceuticals and Diagnostics fields, from early research, clinical development, manufacturing to commercialization. With more than 7,000 employees, Roche China is now working to develop itself into Roche's third global strategic center after Basel and San Francisco, and making sustained efforts to fulfill its long-term commitment to China, so as to meet Chinese patients’ unmet needs.
Roche is an Equal Opportunity Employer.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
