RBQM Change Management & Education Lead

Job Overview:

As a Risk Based Quality Management (RBQM) Change Management and Education lead, you will be assigned to designated Delivery Unit(s),  country/countries, sponsor(s), business units(s), and/or specific tasks as defined by the line manager (LM). Contributes to the development and is responsible for the implementation of specific quality improvement initiatives as agreed with the relevant Head(s) of assigned business lines. Provides advice and supports relevant key stakeholders with regards to quality control, risk assessment, risk management, and corrective/preventive actions.

Essential Functions:

• Developing change management strategies: Creating a comprehensive plan to manage the adoption of RBQM processes, including communication strategies, training programs, and stakeholder engagement initiatives.
• Designing and delivering training programs: Developing educational materials and workshops to educate employees about the changes, addressing concerns, and providing necessary skills to effectively utilize new systems.
• Communicating change effectively: Clearly communicating the rationale behind the change, its impact, and key timelines to all levels of the organization through various channels.
• Issue Management: Solicits and receives escalation of issues related to Study Team's experience of implementation of RBQM by Clinical Research Organization (CRO) and develops strategies and processes to resolve issues. As the organization adopts in-house RBQM services, provides DOQ consultation to support teams in managing issues related to RBQM implementation focusing on education and continuous improvement.
• Stakeholder management: Identifying key stakeholders, managing their expectations, and addressing any resistance to change.
• Monitoring and evaluation: Benchmarking, baselining, analyzing, and tracking the progress of change implementation, identifying areas for improvement, and adjusting strategies as needed.
• Cooperate closely with the relevant business lines and other stakeholders, support maintaining focus on quality in project delivery.
• Provides advice and support to teams within the assigned business line on all aspects of Good Clinical Practice (GCP) compliance.
• Works in close cooperation with teams to manage non-compliance, quality issues
• Assist in planning corrective/preventive actions, as applicable according to Standard Operating Procedures (SOPs).
• Informs the assigned business line and Quality Assurance of quality issues according to SOPs.
• Works closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs.
• May provide assistance during audits and regulatory inspections to the teams to the extent agreed with the line manager, as required by the applicable SOPs.
• Acts as the primary contact for Quality Assurance on quality matters – on the level of the assignment, attend meetings/teleconferences.
• Prepares periodic reports to  business lines on quality related matters, risk assessments and specific quality improvement initiatives.
• Manages staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work, appraising performance and guiding professional development, rewarding and disciplining employees, addressing employee relations issues and resolving problems. Approve actions on human resources matters.;
• Upon agreement with the Head of relevant business line: Performs any other reasonable tasks as required by the role.

Qualifications:

• Master's degree or equivalent with a strong emphasis on business administration, organizational development, or data-science. Consideration will be given to individuals with other educational achievements with a strong overall profile.
• Minimum of 5 years’ experience in a pharmaceutical, bio-pharmaceutical, or Contract Research Organization company, or equivalent.
• Minimum of 5 years’ experience in a role exposed to RBQM or minimum of 2 years' experience in a lead role within RBQM.
• Requires deep knowledge of one or more related job areas typically obtained through advanced education combined with experience.
• Sound working knowledge of relevant terminology, International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), applicable regulatory requirements, quality management processes.
• Excellent organizational, interpersonal and communication skills.
• Excellent judgement and decision-making skills.
• Demonstrated leadership and line management skills.
• Excellent influencing and negotiation skills.
• Strong computer skills including Microsoft Office applications.
• Excellent problem-solving skills.
• Demonstrated ability to work in a matrix environment.
• Ability to lead and motivate a clinical team also required.
• Ability to travel within the region/country.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients.
• Fluent in English.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

The potential base pay range for this role, when annualized, is $117,600.00 - $218,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.