Provides leadership and local strategic planning and organization skills to ensure the effective and efficient delivery of operational aspects of more or more studies through all phases of study management (preparation, conduct, close-out), in accordance with the appropriate quality standards including ICH/GCP/GPP standards, Roche SOPs, local operating guidelines, as applicable.
- For Global/Regional Studies (referred to in rest of this document as Global), the CSM leads and has full accountability (time, quality, cost) of all Affiliate related aspects of a study and ensures delivery of country/regional operational aspects in alignment with the study plans provided by the global Study Management Team (SMT).
- For Local Studies, the CSM acts as study leader and, in addition to the above, provides the leadership and clinical operational expertise for local study team.
Note: Depending on local needs the responsibilities of this role can be extended to include roles and responsibilities of CSS and/or SSUS roles (decision maker local Country Head).
Main Accountabilities and Responsibilities:
Throughout the Study Lifetime:
- Has full accountability for all assigned studies at Regional/country level (Global and local studies) including adherence to quality, timelines and budget.
- Leads local study teams, represents Country/Region Clinical Operation at the global SMT, and provides Global Teams with feedback from a local CCO perspective (Global Studies).
- Leads the local study team, including cross functional group leaders, and ensures GLORA process is followed (Local Studies), if apply.
- Coaches, and provides indirect line management support in partnership with the relevant line managers to Roche in-house study team members (i.e. Country Study Specialist (CSS) and Study Start Up Specialist (SSUS)) by setting clear goals and expectations, monitoring performance, providing overall motivation, support, feedback and follow up to ensure team performance is fully optimized.
- Provides oversight, leadership and support to CRO staff (ie Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs)) to ensure overall delivery at the country and site level (time, quality, cost) and interfaces regularly with local Roche Vendor Manager and CRO Management regarding feedback on CRO staff performance.
- Collaborates in the preparation of local quality/compliance reviews, internal audits and regulatory inspections and ensures adequate and timely CAPA follow up.
- Actively conducts risk management activities (assessment, measurement and mitigation) on an ongoing basis in order to ensure overall delivery at the country and site level (time, quality, cost).
- Identifies areas of best practice and contributes to activities to improve and maintain the quality and effectiveness of processes and activities within the function.
- As requested by local Head of Clinical Operations and/or Therapeutic Area Leaders (TALs) and/or Country Medical Director participates in overall TA support in area(s) of expertise eg future landscaping activities, investigator/site development activities etc
Study Preparation Phase:
- Leads and participates in the preparation phase of the study (feasibility, site selection, initiation) ensuring all other roles that support these activities both within Clinical Operations and externally contribute appropriately.
- Provides support and expertise for regulatory, ethical and administrative submissions.
- Accountable for ensuring investigator site recruitment targets and timelines are realistic and adequate to ensure recruitment to overall country commitment and developing and actively managing study patient recruitment strategies.
- Accountable for the development of the local CCO’s study budget, initial study resourcing forecasts and establishment of study level plans.
- Accountable for ensuring that TMF (country and site level) documentation is Inspection Ready by ensuring there are regular quality checks on the completeness and robustness of study related documents.
Study Conduct Phase:
- In accordance with the overall project plan, manages and maintains accurate country/study level plans (i.e. timelines, budget, resource, risk and quality plans) in appropriate Roche planning system. Highlights deviations in plans to relevant parties, develops and implements mitigation strategies as required.
- Develops and maintains effective working relationships, including being the key point of contact where appropriate, with key internal and external stakeholders, including investigators, local medical team, global study team, other local departments, external vendors/CROs etc.
- In conjunction with local Head of Clinical Operations, Therapeutic Area Leader (TAL) and/or Medical Manager (MM) or the Country Medical Director (CMD), ensures relationships with key investigator sites, alliance partners and/or collaborative groups are optimized to ensure efficient and smooth conduct of the study.
- Ensures all activities related to site/study close-out are managed according to global and local processes.
- Manages either directly or indirectly knowledge sharing activities via debriefs or other focus group activities.
- Education and relevant working experience: University degree or equivalent in a medical/science-related field and/or 5 years proven experience in Clinical Research/Development or related industry.
Skills, Experience and Competencies:
- Leadership: developed through leading multi-functional matrix study teams through all stages of clinical studies
- Project Management: including implementation of risk management plans and management of complex study budgets and resourcing plans
- Communication: excellent written and verbal communication skills demonstrated by the ability to present clear messages from complex information/data to all levels in the organization
- Personal Organization: demonstrated ability to prioritize and manage multiple tasks, self-motivated and achievement driven.
- Good knowledge of ICH GCP, GPP, Roche SOPs/Guidelines and quality standards related to study management.
- Clear and accurate communication in written and spoken English.
- Strong computer skills.
- Clinical development experience on the operational aspects of conducting clinical studies including:
- vendor/CRO resource management
- leading/working as part of a development team
- implementing clinical development plans
- risk management
- coordinating study level activities to deliver data for filing or publication purposes including interaction with local Business Units
- Demonstrated ability to interact with different professional levels of the research community
- Experience of influencing and negotiating at all levels to achieve team delivery
- Availability to travel domestically and internationally if required.
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