Job Purpose and Key responsibilities As an Business Excellence Lead Consultant, you will be working from our client site and providing guidance and hands-on in the field in the day to day activities to Bio-statistics and Statistical Programming (BSP) teams in the following topics:
Process Maintenance and Improvement
Contribute to the development, improvement & simplification of standards and processes across BSP within Clinical Evidence Generation (CEG). Ensure that standards and processes are implemented globally throughout CEG with a high level of compliance and quality.
Risk-Based Monitoring (RBM)
Support the RBM core team in managing the process and system used for RBM, including audit preparedness and CAPA resolution
Quality Tolerance Limits (QTL): maintain the Work Instruction and set-up training to study teams, be the point of contact for study teams. Development of standard tolerance limits within GSK Vaccines (according to country, disease, population,…)
Oversight: Ambassador for the study oversight process and tool; Perform Gembas and support BSP team.
Maintain ongoing communication with designated members from Clinical Quality (Q4RD), Performance and Risk Management (PIO), Regional Evidence Generation, Medical Governance, CDQA, Pharma R&D to address risk management issues, to align corporate initiatives, to ensure E2E cross-functional approach, to work on trends, problems, issues, and other clinical monitoring opportunities in an efficient way.
Minimum Bachelor degree in Computer Science, Life Science or related area. Area of Specialisation will be in Engineering, Life Sciences, Computer Sciences, Quality, Mathematics and Physics or equivalent, knowledge of business or project management practices. This role requires a broad knowledge of the theory and practice of clinical research in a regulated environment. A good understanding of the work environment is needed to evaluate risk, impact of deviation & develop mitigation plan. Master Degree (or equivalent) is preferred.
This role will have extensive involvement with external partners at multiple levels of management. The responsible person must be comfortable in all areas of discussion with any level of partner organisation (content, process, issue management, strategic planning, etc.).
Given the nature of the job and its associated responsibilities, a good scientific background associated with operational and project management skills are preferred.
Given the complex environment the profile requires to be at ease both with scientific aspects and process elements. The role interface directly with different levels in the organisation and must be able to adequately convey our client's positions and requirements to a highly educated partner group.
Experience/Competences & Skills
A minimum of 3 years of strong project management experience required, preferably in clinical development and clinical operations, preferably of vaccines/biologic development
Good knowledge of R&D and clinical trial environment. Knowledge of the overall vaccine discovery and development process, organisation and procedures
Thorough knowledge of overall clinical development process specifically centred around programming, statistics, data management, GCP regulations, sound research and development practices, scientific terminology, company procedures and policies.
Demonstrates ability for leading initiatives with cross functional teams and implementation of recommendations.
Detail oriented, have excellent communications, organisation, investigation and negotiation skills, be diplomatic able to establish priorities and develop and implement new procedures when needed as well as predisposition to quality management, project management and process improvement.
Superior interpersonal skills and expert team player with demonstrated ability to build collaborative relationships at all levels inside and outside of the organisation, specifically with line management staff and with management at all levels in partner vendor organisations
Good negotiating, networking experience and advance problem solving skills.
Superior analytical skills and ability to think/frame problems strategically
Well-organised, excellent time management with respect to priorities and self-management
Able to work in ambiguous circumstances and take actions quickly while involving the right team members in the right situation at the right time
A minimum of 3 Years in working in an International environment with individuals of various cultural background
Due to the sensitive information and global view of the position this person needs to have experience in all stages of clinical development as well as being self-disciplined, self-driven, and professional.
Ability to work well within a matrix environment, balance priorities, and handle multiple tasks through good planning, project administration, and organisation skills.
Effective ability to prioritise tasks and deliver on deadlines, with high performance standards and a commitment to excellence.
A high level of business acumen, collaborative problem solving, and vendor management expertise are expected. Strong interpersonal skills and a demonstrated ability to manage vendor relationships are also required.
Other Job-Related Skills/Background Language skills:
Fluent English (spoken and written)
French and Italian a plus
Strong business excellence focus
Strong customer focus
Good networking skills
Ability to work in multi-cultural teams; positive team spirit and interpersonal skills
High level of flexibility and sense of urgency
Operates with a high degree of integrity, responsibility, independence and initiative
Is an organiser/planner/analyser/implementer/problem-solver with tact and diplomacy.
Is self-driven by successful execution of different tasks
Good Project Management skills
Experienced in Data Management, Clinical Systems and/or Exploratory Data Analytics
Good understanding of regulations including ICH GCP
Basic knowledge of CDISC and ADaM
Experience in working with other functions aside from operations;
ICH-GCP/PV-related role/experience would be a useful asset
Experience in Risk Management and Management Monitoring is an asset