Provides leadership to one or more Local Study Teams (LSTs) and provides local strategic planning and organization to achieve successful study completion. The CSM maintains full ownership of the local CCO portion of a study and ensures the effective and efficient delivery of country/region operational aspects in accordance with the study development plan and ICH/GCP standards, Roche SOPs, local operating guidelines and local regulatory requirements. The CSM also ensures the development and maintenance of productive relationships with our customers.
Principle Accountabilities and Responsibilities:
Provides Direction and Leadership to one or more LSTs:
Builds effective, high performing LSTs through influence, integration, motivation and optimization of team performance. Embeds the Roche values into the team(s) culture and promotes the team spirit.
- Sets the LST goals and ensures goals are in line with the operational strategy agreed by Clinical and Study Management Teams. Provides coaching to the team to facilitate the setting and achievement of goals.
- Ensures that each team member is aware of his/her specific area of accountability and responsibility within the LST.
- Manages and coaches performance of study team members by setting expectations, supporting team members, monitoring performance, providing feedback and following up, when appropriate to ensure performance is optimized.
- Liases with other functional groups to ensure the LST(s) members and monitors receive appropriate therapeutic area and study specific training.
Establishes Study Timelines, Budget, Resource, Risk and Quality Plans:
Provides the GSM with feedback from the local CCO perspective into the study synopsis, development of the final protocol, feasibility conduct and all study specific documents and procedures.
- Oversees project, protocol, site feasibility and determines site selection and patient allocation (total and annualized) with local CCO and the HQ study (GSL and GSM).
- Analyzes results of project, protocol and site feasibility testing, and provides country feedback or recommendations to SMT.
In accordance with the overall project plan, establishes and maintains accurate study level plans in PlanSource.
- Develops local CCO scenario plans that deliver the studies on time, with the most efficient use of budget and resources.
- Develops country/regional level study timelines and ensures that milestones are set and managed for the overall studies delivery in association with the GSM.
- Develops and manages local CCO budget/financial plan, and forecasts using appropriate tools, ensures the LST(s) has the appropriate resources to effectively deliver high quality studies on time and within budget.
- Responsible for ensuring site level contracts are completed.
- Provides input from a country/region perspective into development and implementation of drug management, contracts, budgeting, resourcing, source document verification, data flow, case report forms, and safety monitoring for the local CCO via the GSM.
- Provides input on local requirements for biologic sample plan to the Global Biosample Specialist.
- In collaboration with the GSM and where necessary, PDQ, develops and executes the local implementation of the audit quality and risk management plans identifying critical issues for the local CCO and ensuring contingencies are established and captured in the study level risk management plan. Ensures that the plans are reviewed and updated over the course of the studies.
- Provides content review and input into the global communication plan.
- Develops local LST communication plan.
Is accountable for the development and active management of the study patient recruitment strategies in the local CCO.
- Develops country recruitment plan for the local CCO and manages patient recruitment strategies.
Develops Partnership with Business, participates on local life cycle teams, consults local Business Units, and participates in local Business Unit meetings as necessary.
Is accountable for the selection, training and management of external suppliers supporting the local CCO.
Manages the Delivery of Study Activities in Order to Meet Study Plans:
Is accountable for all local CCO regulatory, ethical and administrative submissions.
- Design and implement a country level training plan to ensure that team members and investigators receive training on the protocol, ICH/GCP requirements, and applicable Roche process/procedures.
- Ensures protocol adherence and consistency of study processes and procedures across all local CCO investigational sites.
- Ensures studies in the local CCO are performed and conducted in compliance with ICH-GCP guidelines, Roche SOPs, local operating guidelines and all applicable regulatory requirements.
- Ensures patient safety and data quality maintained, and that any concerns are escalated appropriately.
- Ensures monitoring reports are timely, reviewed and takes appropriate actions for follow up on site issues.
Ensures that data is delivered in accordance with established dataflow timelines.
- Ensures that trial management tracking tools (e.g. CTMS/CTP) and systems are populated and maintained.
Develops/maintains investigator relations, builds and maintains a professional relationship between Roche and Investigator, participating in local CCO Investigator Meetings as necessary.
- Leads and or organizes (or assists in organizing) and/or participates in local or regional meetings and training sessions (i.e. LST meetings, Investigator Meetings, Monitor’s Workshop and CRO training).
Implements the country-level recruitment plan.
Monitors progress against LST goals and takes appropriate action to ensure goals are met and issues are communicated with the appropriate persons or teams.
- Chairs LST meetings, ensuring appropriate follow-up is taken on action points.
- Provides the SMT (via the GSM) with regular status updates with regard to local CCO recruitment and investigational sites.
- Communicates regularly on country/region study(s) status and escalates unresolved issues appropriately to the Country Head, Line Manager and or Team Leader.
- Ensures use of site recruitment plans.
- Maintains tracking of study status.
Oversees the management of the local CCO studies budget.
Identify Areas of Best Practice and Process Improvements:
Leads the evaluation of standards across one or more LST(s) with the objective of enhancing quality, productivity and efficiency.
- Proactively incorporates learnings and recommendations from study debriefs and best practices.
- Maintains oversight and ensures consistency across studies within a project at the local CCO level.
Qualification and Experience:
- 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.
- Able to communicate clearly and accurately in both written and spoken English.
- Demonstrated ability to interact with different professional levels of the research community.
- Strong leadership skills developed through leading multi-functional matrix study teams through all stages of clinical studies.
- Proven clinical development experience on the operational aspects of conducting clinical studies including vendor/CRO management, leading/working as part of a development team, implementing clinical development plans and coordinating study level activities to deliver data for filing or publication purposes including interaction with local Business Units.
- Experience in project management including implementation of risk management plans and management of complex study budgets and resourcing plans.
- Experience influencing and negotiating at all levels to achieve team delivery.
- Excellent written and verbal communications skills demonstrated by an ability to present clear messages from complex information/data to all levels in the organization.
- Demonstrated ability to prioritize and manage multiple tasks.
- Self-motivated and achievement driven.
- Strong computer skills – experience using various computer applications including spreadsheets, emails, word-processing software.
- International travel required.