Manager, Clinical Trial Safety

IQVIA; Warszawa; On-site; PLN 202,000 - 374,000; Full time

Job summary

IQVIA in Warszawa, Poland seeks an experienced leader to oversee a group responsible for high-quality medical data review and safety assessment. You will collaborate with Study Physicians and Clinical/Project Scientists, providing consolidated data to inform medical decisions.

The role includes mentoring staff, managing performance, ensuring training compliance, and driving continuous improvement across study start-up, maintenance and closure in a global setting.

Qualifications

• Advanced degree in medical or life sciences.
• At least 3 years in clinical research, pharmacovigilance or safety and data review.
• Strong knowledge of GCP/ICH and regulatory guidelines.
• Proven project management and leadership in global teams.
• Excellent English communication in scientific environments.

Responsibilities

• Lead line management of a group of individuals and oversee performance.
• Oversee the full range of clinical/safety data review activities.
• Collaborate with Study Physicians and Clinical/Project Scientists.
• Ensure compliance with policies, procedures and training requirements.
• Mentor junior staff and support onboarding and development.
• Drive strategic initiatives and continuous improvement across studies.

Skills

Line management

GCP/ICH knowledge

Project management

Leadership

English proficiency

Cross-functional collaboration

Pharmacovigilance experience

Education

Advanced university degree in a medical/life science field

Tools

MyTime

Job description

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, supportneeded, to provide and collect feedforward, support performance development, including goal setting andperforming 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 ensurecontinuous 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 andcommunicates 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 andexecution 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 ofthe relevant documents and tools configurations
• Oversees the process implementation and ongoing review and querying of critical clinical/ safety data to ensurescientific 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 assignedprojects 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 highscientific and operational quality and standardization within program/molecule/indication
• Acts as a trailblazer in the clinical projects from the therapeutic area/ indication/ moleculeperspective 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 medicalcompleteness, 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 ofonboarding and mentoring processes in the department
• Leads quality of own deliverables and oversees quality of more junior staff by performing regular quality checks onstudy 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 reviewmethodology or equivalent combination of scientific research activities
• In-depth understanding of the clinical study and drug development process and GCP/ICH guidelines; extensiveknowledge of applicable regulations and guidelines, including SAE reporting requirements; understanding of clinicaldata flow, demonstrated current understanding of organisation, scope, challenges and opportunities
• Proven project management capabilities; ability to manage change, risks, priorities and performance targets; showingexcellent time management skills, and ability to multi-task in a high-volume environment with shifting and/orcompeting priorities
• Solving complex, diverse, multifactorial problems; managing change and uncertainty - for self and teams; supervisingothers' work and providing support; setting own and team objectives, aligning with business objectives/strategy
• Managing/negotiating diverse/conflicting stakeholder interests; multidisciplinary communications and two-wayinfluencing; presenting and collaborating, securing buy-in on complex problems with diverse audiences; proven abilityto interact effectively with all levels of management, demonstrated leadership ability in a team environment; provenability 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 addvalue 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 andmanage 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.

The potential base pay range for this role, when annualized, is zł201500,00 - zł374100,00. 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.