Associate Director RWE Clinical Operation Lead
Lisbon, Portugal
há 4 dias

Job Overview

Direct and manage an assigned team of Site Management Leads staff 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 employees are trained and individual development is aligned and in place to meet project and organizational needs

Essential Functions

  • Manage 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.

  • Work with the Site Management Leads to ensure patient recruitment, project budget(s) meet financial and company goals (realization targets), with a focus on adherence to change control processes.
  • Ensure all study management and project deliverables are completed per the agreed strategy and contract. Achieve quality deliverables on time and within budget and in accordance with Standard Operating Procedures (SOPs), policies and practices with a primary focus on timely patient recruitment.
  • Provide effective and timely consultation / guidance to Site Management Leads on issue resolution.
  • Serve as a Site Management Lead liaison with other groups within IQVIA, helping to create solution alliances across delivery platforms and enabling ease of customer business relationships.
  • May take a lead role in developing long standing relationships with preferred IQVIA customers and initiate cross functional issue resolution to meet customer needs adapting IQVIA processes.
  • Drive consistency of operational delivery across customer’s projects / programs; make sure plans are implemented following approval by senior management.
  • Provide consultation to clients on strategy and plans as needed, in particular around patient recruitment and Site Activation.
  • Collaborate with other leaders to build business acumen expertise through identification of and addressing industry trends.
  • Maintain current product and project knowledge.

  • Collaborate with other management and leadership team members to proactively identify resourcing solutions and project and / or individual needs to manage studies.
  • Work with individual staff to identify any quality issues within the study and provide coaching on resolution of issues, including implementation of corrective and preventative action plans and escalation.
  • Direct, manage and mentor an assigned team of Site Management Lead line managers or Site Management Leads who lead or support studies or programs.
  • Actively provide guidance / coaching around project planning, project review and Finance, risk management and problem solving to achieve global alignment of work practices across the team through the adoption and use of all process and technology tools and improvements by employees.

  • Support the sales process and participate in bid defense meetings.
  • May serve as a back-up on projects as needed.
  • Participate in and champion function and / or corporate initiatives, changes and / or special assignments; act as a client liaison, departmental cross-functional liaison and / or change agent;
  • provide technical expertise and clinical project management experience to project management and training and process improvement efforts.

  • Serve as liaison for non-specific projects for key customers.
  • Qualifications

  • Bachelor's Degree Health care or other scientific discipline or educational equivalent. Req
  • 12 years of clinical research experience including 8 years experience in a leadership capacity, including multi-regional and global focus; Req
  • or equivalent combination of education, training and experience. Req
  • Excellent knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Broad protocol knowledge; therapeutic knowledge desired
  • Excellent understanding of Clinical Research industry (drug / device / technology / etc.) and the relevant environments in which it operates
  • Very Strong understanding of the competitive environment and how to communicate / demonstrate value through IQVIA solutions
  • Excellent understanding of other IQVIA functions and their inter-relationship with Project Leadership
  • In depth understanding of project management practices and strong history of demonstrated project management capabilities
  • In depth understanding of, and experience managing, contractual obligations and implications
  • Demonstrated strong understanding of project financials and managing project P&L
  • Proven ability to manage a team and work through others in a global environment to deliver results to the 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

  • Excellent customer service skills and demonstrated ability to understand customer needs, have difficult conversations with internal / external stakeholders and customers, and negotiate solutions
  • Ability to manage competing priorities
  • Good judgment and decision-making skills
  • Excellent mentoring and training skills, fostering learning and knowledge sharing with colleagues
  • Very Strong presentation skills
  • Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving
  • Excellent communication skills, including good command of English language
  • Strong software and computer skills, including MS Office applications
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
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