Clinical Operations Lead at Roche Kenya

The Position
Clinical Operations Lead (COL)
Roche Pharma in Kenya is seeking a Clinical Operations Leader to:

• ​work in a cross-functional, matrixed organization, and is empowered to work with people across the organization to enable all teams to perform at their best, foster a growth mindset to optimize potential and talent, and flow to high impact work to advance our medicines for patients.
• The COL has the opportunity to work across one or more areas of Product Development, including global study management, patient/disease areas, local country clinical operations, bio sample management, quality management, systems and process development, learning, insights and analytics, as well as strategic focus areas such as innovation and creativity, investigator centricity and partnering, patient and caregiver benefit, inclusive research, diversity and inclusion, talent flow, and other areas.​
• The COL 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 role leads and has full accountability (time, quality, cost) in alignment with the Study Management Team (SMT)
  • For Local Studies, the role acts as study leader and, in addition to the above, provides the leadership and clinical operational expertise for the local study team.

Roles 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 a 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 of study results in line with Roche global publication policy and timelines.
•  Acts as NIS Responsible who is responsible for managing and overseeing the conduct of a Non-Interventional Study (NIS) in accordance with the NIS associated Global procedural documents.
•  Updates knowledge on related regulatory requirements, ensures adherence and compliance with local regulations and internal procedures.
•  Executes study start-up activities prior to site activation on assigned studies, according to Roche standards and aligned with study/project requirements and timelines. Prepares country and/or site Informed Consent Form (ICF) and clinical study documents which need translation from English into local language.
•  Obtains ethics committees' and local regulatory authorities' approval. Prepares ongoing submissions, amendments and periodic notifications required by ethics committees and regulatory authorities as needed within the country. Update the relevant systems as required for tracking of the local IRBs/IECs and regulatory authorities activities .
•  Maintains and analyzes study start-up data (metrics) on assigned studies, ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement.
•  Partners with other Clinical Operations colleagues as needed to provide guidance on regulatory/ethics requirements, to track and drive site activations and trial amendments submissions, by regularly reviewing and monitoring status of submissions/activations.
•  Liaises and collaborates with relevant authorities/bodies to further enhance clinical trial process, government policies/ laws, via innovative approaches
•  Submits, where applicable and according to local regulatory requirements, all Suspected Unexpected Serious Adverse Reactions (SUSARs), Six Monthly SUSAR Reports (SSRs) and Development Safety Update Reports (DSURs) in collaboration with LSR and/or PV Hub.
•  Identifies and tracks new investigator sites performing feasibility, as applicable, and develops and supports effective patient recruitment and retention practices, as required.
•  Manages study budget process and is responsible for contracts negotiation and ensures compliance with Fair Market Value (FMV) in the country.
•  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).
•  Responsible for driving selection of clinical studies of interest in the country during the study pre-start-up phase.

Qualifications

•  University degree or equivalent; preferably in a medical/science-related field.

Experience and Knowledge

•  Atleast 4-years experience and expertise in clinical research/development or related industry. Extensive experience in clinical trial project management.
•  Working knowledge of drug development and clinical operations or related areas of expertise.
•  Knowledge of best practices and the role of clinical operations in pharma product development; Aware *of Roche’s
• place in the market and our value proposition to patients.
•  Developing leadership skills, mentoring and coaching colleagues with less experience and provide guidance; may also lead parts of projects.
•  Solves complex outcomes; takes a new perspective on existing solutions; exercises judgement based on analyzing multiple sources of information and advice.
•  Explains complex information to others in straightforward situations.

Skills and Competencies

•  Provides subject matter expertise on specific clinical operations activities or through supporting the execution of clinical trials and/or enabling projects across geographies.
•  Identifies, contributes to and participates in continuous improvement and change management activities to solve complex problems and bring- new perspectives.
•  Independently and with minimal guidance develops plans to support execution of clinical trials and/or enabling projects.
•  Collaborates across PD and other functions in the delivery of the portfolio.
•  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.
•  Understands, applies proficient knowledge of, and ensures adherence to ICH, GCP and regulatory guidelines within clinical trials or enabling activities.
•  Has knowledge of other business functions in the organization and learns the upstream and downstream impacts of their team’s decisions including resourcing, on other parts of the business.
•  Participates in identifying vendors, builds relationships and partners to ensure the execution of clinical trials and/or enabling projects.
•  Awareness of the external environment and how we operationalize our clinical trials.
•  Work closely with investigator and clinical site staff with a continuous focus on partnership and aiming to position Roche as a preferred partner.