Manager, Clinical Trial Safety
IQVIA · Madrid
Responsible for line management of a group of individuals and has shared accountabilities for service resulting in high quality medical data review.
He/she may have also responsibilities associated directly with the clinical data review (will work in close collaboration with the Study Physicians and Clinical/Project Scientists providing them consolidated data supporting high quality medical/ safety evaluation).
Accountabilities:
- Has regular meetings with employees to discuss with employee any important business topics, workload, support needed, to provide and collect feedforward, support performance development, including goal setting and performing regular check-ins during the year (as per applicable process); supports and motivates employees, provides required help and removes barriers
- Performs work allocation/ resource management duties
- Works according to agreed functional and regional SHE strategy by ensuring proper management of SHE risks, incidents, reporting, follow-up and improvements
- Undertakes the full range of duties relevant to mentoring/coaching and development of the individual to ensure continuous professional development of the employee and development planning
- Participates in formal staff review process (e.g. performance and salary review)
- Ensures that employees adhere to corporate policies, procedures and guidelines
- Ensures that employees comply with training requirements
- Ensures that employees comply with all rules and duties including but not limited to reporting in MyTime, financial reporting, QI reporting
- Recruits new individuals
- Supports employees in the process of onboarding, induction and offboarding
- Maintains a positive, result-oriented work environment, building partnership with other functions and communicates in an open, balanced and objective manner
- Has personal responsibility for creating a culture of courageous leadership, creativity, speak-up culture, feedforward sharing
- Provides strategic assessment, with an enterprise mindset and accountability for the proactive development and execution of Strategy
- Proposes and leads/supports the implementation of strategic initiatives, innovation and best practices
- Collaborates with Study Physician and/or Clinical/Project Scientist and other study team members, if applicable providing scientific and operational input as well as oversight of team dedicated to study start-up, maintenance and closure activities and give consistent program/molecule/indication level input into generation of the relevant documents and tools configurations
- Oversees the process implementation and ongoing review and querying of critical clinical/ safety data to ensure scientific quality and standardization on a program/ molecule/ indication level
- Ensures seamless and complete clinical data review
- May support scientists in day-to-day handling and querying of clinical/ safety data within assigned projects and will review the data for medical completeness, scientific accuracy, and coding consistency
- Ensures effective cross-functional collaboration between staff and all stakeholders engaged in clinical/ safety data review on a program/ molecule/ indication level
- Ensures feedforward collection, lessons learned sharing, and transfer of learnings between studies to support high scientific and operational quality and standardization within program/molecule/indication
- Acts as a trailblazer in the clinical projects from the therapeutic area/ indication/ molecule perspective as well as the new scope and new tools & associated processes perspective
- Acts as role model of project leader/ project expert – either as the project Primary Point of Contact (POC) and/or clinical/ safety data reviewer in the studies of high complexity and importance
- Project subject matter expert for any topic related to handling of medical/ safety data, such as review for medical completeness, medical accuracy, and coding consistency
- Mentor and trainer for more junior staff to ensure consistent processes and efficient review of critical medical/ safety data across studies within the same molecule/program/indication, contributing to development of onboarding and mentoring processes in the department
- Leads quality of own deliverables and oversees quality of more junior staff by performing regular quality checks on study level
Education, Qualifications, Skills and Experience
- Essential:
- Advanced university degree in a medical/life science field
- Minimum 3 years of experience working in clinical research, pharmacovigilance and/or safety and clinical data review methodology or equivalent combination of scientific research activities
- In-depth understanding of the clinical study and drug development process and GCP/ICH guidelines; extensive knowledge of applicable regulations and guidelines, including SAE reporting requirements; understanding of clinical data flow, demonstrated current understanding of organisation, scope, challenges and opportunities
- Proven project management capabilities; ability to manage change, risks, priorities and performance targets; showing excellent time management skills, and ability to multi-task in a high-volume environment with shifting and/or competing priorities
- Solving complex, diverse, multifactorial problems; managing change and uncertainty - for self and teams; supervising others’ work and providing support; setting own and team objectives, aligning with business objectives/strategy
- Managing/negotiating diverse/conflicting stakeholder interests; multidisciplinary communications and two-way influencing; presenting and collaborating, securing buy-in on complex problems with diverse audiences; proven ability to interact effectively with all levels of management, demonstrated leadership ability in a team environment; proven ability to facilitate team building and teamwork
- Excellent knowledge of spoken and written English - communication in a scientific environment; computer proficiency
- Positive approach to individual, team and business changes, perceived as opportunity to improve performance and add value to the business
- Experience in cross-functional pharmaceutical development, proven leadership experiences (people and project) including team facilitation skills and strong collaborative communications ability to diverse client base
- Line management experience
- Ability to effectively lead complex non-drug projects in a world-wide environment, demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global and regional environment
- Conceptual and strategic thinking; concern for standards and willingness to learn from others
- Has knowledge on Procedural documents as they pertain to study delivery systems and processes
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 committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies.