Country Study Manager

The Position
Objectives and Scope of Position
* The Clinical Operations Hub Country Study Manager (CSM) provides leadership and hub 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.
* For Global/Regional Studies (referred as Global), the CSM leads and has full accountability (time, quality, cost) in alignment with the 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 the local study team.
Role and Responsibilities
Main Responsibilities and Accountabilities
* Has full accountability and oversight for all assigned studies at the hub level (Global and Local studies) 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 parties, develops and implements mitigation strategies as required.
* Leads local study teams, represents hub Clinical Operations at the global SMT, and provides Global Teams with feedback from an Affiliate perspective (Global).
* Plans and executes country study goals and commitments, and ensures compliance to relevant processes.
* May serve as global Country Study Representative (gCSR), as part of global study team.
* Coaches and provides support to responsible study team members.
* Provides study oversight, leadership and support to Contract Research Organisation (CRO) staff to ensure overall delivery at the country and site level, and interfaces with CRO Management regarding feedback on CRO staff performance as required.
* Oversees study feasibility, site monitoring performance, preparation of Risk Based Monitoring plans, and ensures eTMF completeness and oversight of all relevant compliance activities for allocated studies.
* Approves the validated clinical study documents which were translated from English into local language and /or back translated from local language into English.
* 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, alliance partners and/or collaborative group for current and future Roche studies.
* Participates in overall Therapeutic Area support together with the therapeutic leads and country experts (e.g. landscaping activities, investigator/site development activities or affiliate cross functional teams, etc.), as required.
* Identify Principal Investigator and all other Sub-Investigators to be involved in the study.
* For local studies, ensure publication within six months from the date the Clinical Study Report (CSR) was in place in accordance with Roche global publication policy.
Clinical Trials SPOC for the affiliate (Country SPOC) __
* Country SPOC is the person nominated by the Head of ME Clinical Operations Hub who is responsible for providing requested quality or other data for particular country. Country SPOC could have different roles within the Hub structure; however should be knowledgeable about the respective country and most preferably located in that country.
* Act as Single point of contact for consolidation of clinical operations inputs for all requests (for e.g. AMPs, ABPs, business reviews, data collection, etc) coming from different stakeholders at the country/affiliate level (for e.g. commercial, medical affairs, safety, regulatory, etc). All communication from Clinical Operations Hub side that are study specific should be handled by the CSM directly to the relevant stakeholder. All requests from the affiliate that are study specific, which the CSM does not know, should be sent to Country SPOC who should forward to the responsible CSM.
* Act as representative of the Clinical Operations Hub in the Local Medical Compliance Office (LMCO) meetings conducted at the country/affiliate level. Country SPOC should attend and participate in such meetings.
* Handle reactively requests from LQR and APT for consolidation of the country clinical operations data for the affiliate core compliance metrics and Affiliate Passport.
* Communicate inputs from all CSMs working in the SPOC country on budget forecasts, budget deviations and budget updates during review rounds to relevant stakeholders. Country SPOC makes sure that Hub Head is fully aligned at all times. Country SPOC needs to be added in finance communication as the country contact.
* Manage invoices before sending to the affiliate/country finance team (in case the CSS is not located in country) for the tasks that can't be handled remotely.
* Responsible for driving selection of clinical studies of interest in the country during the study pre-start-up phase when the bucket is received form EEMEA Clinical Operations Leader.
* Responsible for country contacts list update on a regular basis and as needed (for e.g. country contacts for safety, quality, regulatory, medical manager,etc).
Country Study Specialist Line Manager
Lead the CSS team (in Saudi Arabia) and be accountable for the following
tasks assigned to CSS team :
* Managing the CSS team performance to their assigned tasks and responsibilities as planned and as per the assigned targeted objectives
* Managing issue escalation in case raised from any Country Study Managers , implementing the root cause analysis and the related Corrective and Preventative actions
* Monitoring KPIs related to the CSS team , including qualitative/ quantitative performance measures and as per the agreed timelines.
* Team development , motivation and engagement
* Team Induction and Training within the allowed timelines
General (Mandatory)
* Attend / complete all requisite on-line and F2F trainings (Role specific, Safety responsibility and Compliance) within specified time limit
* Identify, collect and immediately report all safety related information on Roche products to Local Safety Responsible as per Roche requirements and local regulations
Adhere to company (both local and global) policies and procedures at all
times, including Health & Safety requirements.
Essentials
Qualifications
University degree or equivalent; preferably in a medical/science-related
field.
Experience and Knowledge
Extensive experience and expertise in clinical research/development or related
industry. Extensive experience in clinical trial project management.
Skills and Competencies
* Decision Making - identifies and understands problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information; choosing the best course of action by establishing clear decision criteria, generating and evaluating alternatives, and making timely decisions; taking action that is consistent with available facts and constraints, and optimizes probable consequences.
* Planning and Organizing (Achieving Results/Strategic Agility) - establishes an action plan for self and others to complete work efficiently and on time by setting priorities, establishing timelines, and leveraging resources.
* 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.
* Building Partnerships (Teamwork and Collaboration) - develops and leverages relationships within and across work groups to achieve results.
* Influencing (Inspiring and Influencing) - uses effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions that support specific work outcomes.
* Customer Orientation (Technical & Business Expertise) - places a high priority on the internal or external customer's perspective when making decisions and taking action; implements service practices that meet the customer's and own organization's needs.
* Coaching (Feedback and Coaching) - engages individuals in developing and committing to an action plan that targets specific behaviors, skills, or knowledge needed to ensure performance improvement or prepare for success in new responsibilities.
* Work Standards - sets high standards of performance for self and others; assumes responsibility and accountability for successfully completing assignments or tasks; self -imposes standards of excellence rather
than having standards imposed.
* Innovation - creates novel solutions with measurable value for existing and potential customers (internal or external); experiments with new ways to solve work problems and seizes opportunities that result in unique and differentiated solutions.
* Valuing Differences - works effectively with individuals of diverse cultures, interpersonal styles, abilities, motivations, or backgrounds; seeks out and uses unique abilities, insights, and ideas from diverse individuals.
Technical/Professional Knowledge and Skills - has achieved a satisfactory
level of technical, functional, and/or professional skill or knowledge in
position -related areas; keeps up with current developments and trends in
areas of expertise; leverages expert knowledge to accomplish results.
Key Relationships to reach solutions
Internal
* Head of Clinical Operation Hub
* ClinOps Hub team
* ClinOps Hub Affiliate Process and Training Manager
* Country Safety Responsible
* Country Quality Responsible
* Country Medical Affairs
* Country Regulatory Affairs
* Global SMTs
* EEMEA ClinOps network
External
* Investigators and study teams
* Ethics committees
* Health authorities
* CRO
* Other GCP vendors
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 is an Equal Opportunity Employer.