Director, Clinical Leads in Bucureşti

DIRECTOR, CLINICAL LEADS

Based in Europe

Provide oversight and leadership to Clinical Leads (CL) for project productivity, delivery and quality resulting in strong financial performance and customer satisfaction. Work with Clinical Lead (CL) teams to focus on leveraging deep therapeutic expertise and IQVIA solutions to drive operational excellence and strategic leadership with our customers. Direct and manage an assigned team of clinical leads who lead or support studies or programs to make sure quality, time and budget deliverables are met to the Sponsor’s satisfaction and in accordance with Standard Operating Procedures (SOPs), policies and practices. Ensure Clinical leads are trained, and individual development is aligned and in place to meet project and organizational needs. Attract, develop and retain talent.

RESPONSIBILITIES

  • Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, (Standard Operating Procedures (SOP)s, project plans). Ensure all Clinical Leads (CLs) obtain Fundamental GCP accreditation during a two-year cycle.
  • Actively engage with Clinical Leads (CLs) to review project performance and deliverables. Address Clinical Lead (CL) performance issues and/or escalations by working with Clinical Leads (CLs) to create action/recovery plans. Ensure compliance to the Clinical Lead (CL) metrics dashboard of all direct reports. Foster an environment where lessons learned are shared within the team.
  • Ensure compliance on the overall Risk Management process including risks that are escalating into issues. Work with Clinical Leads (CLs) on identification of risks that can lead to processes improvement/standardization across the organization.
  • Ensure compliance to quality management processes that apply to all projects. Support quality initiatives and ensure quality metrics are met at all times.
  • Mentor Clinical Leads (CLs) to manage clinical aspects of Project Finances including Estimate at Completion (EAC). Support CLs to understand the scope of clinical delivery and create plans to deliver against this scope and to monitor and manage changes against baseline EAC and identify additional service opportunities or out of scope work.
  • Support Clinical Leads (CLs) in baselining and updating Project Schedules, to align with the stage of the project and ensure Project Schedules are published on a timely basis for actual dates and changes in forecasted days.
  • Coach Clinical Leads (CLs) to identify Out of Scope items, discuss impact and proactively suggest remediation plans when considering risks/delays and present these to Project Leads to determine appropriate action. Discuss proactive identification of milestone risks by Clinical Leads (CLs).
  • Actively review project level clinical metrics with Clinical Leads (CLs) to ensure compliance and accuracy of data. Support Clinical Leads (CLs) during Project Review Meetings. Ensure compliance to all critical data fields within Project Management systems. Coach Clinical Leads (CLs) on running and reviewing various project reports.
  • Resourcing and Talent planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.
  • Participate in function and/or corporate initiatives, act as a departmental cross-functional liaison and/or change agent, provide technical expertise and project support experience
  • Conduct progress reviews and evaluations, and create contingency plans to mitigate project, program-level and enterprise risks.
  • Mentor Clinical Leads (CLs) for further development and ensure they follow an Individual development plan.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Knowledge of clinical trials - In depth knowledge and skill in applying, applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Strong understanding of the Clinical Research Industry and the relevant environments in which it operates.
  • People Management - Proven ability to manage a team and work alongside others in a global environment to deliver results to the meeting appropriate quality and timeline metrics. Provides others with a clear direction, delegates work appropriately and fairly, motivates and empowers others, monitors/manages performance and provides feedback and coaching; recruits, develops and retains staff of a high caliber. Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.
  • Collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences. Ability to establish and maintain effective working relationships with co-workers, managers and clients.
  • Leadership - Ability to successfully manage competing priorities. Excellent customer service skills and demonstrated ability to understand customer needs, have difficult conversations with internal stakeholders and customers as well as negotiate solutions. Good judgment and decision-making skills.
  • Organization - Strong presentation skills. Strong organizational and problem-solving skills. Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving. Strong understanding of other IQVIA functions and their inter-relationship with Project Support Units.
  • Communication - Excellent communication skills, including good command of English language.
  • Results Oriented - Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
  • IT Skills - Strong software and computer skills, including Microsoft Office applications.
  • IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, Innovation, Ownership).

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Requires 12 years of clinical research experience including 8 years leadership experience, multi-regional and global focus or equivalent combination of education, training and experience.
  • Requires broad management knowledge to lead cross-regional teams, and well as the ability to influence others outside of own job area regarding policies, procedures, and goals.

Contact

Datele de contact vor fi vizibile dupa ce veti aplica!

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