Associate Clinical Project Management Director, IQVIA Biotech

About the role

Manage and support the operational elements and execution of studies and/or programs to ensure delivery on time and to quality standards, resulting in strong financial performance and customer satisfaction, in accordance with SOPs, policies, and practices from pre-award to close-out. Work with study/program teams to leverage deep therapeutic expertise and IQVIA solutions, driving operational excellence and strategic leadership with customers.

Responsibilities

• Participate in bid defense preparations and lead bid defense presentations in partnership with Business Development for large, multi-country and/or multi-regional studies.
• Understand project strategy and operationalize the agreed-upon approach.
• Develop and/or support preparation of integrated study management plans in collaboration with the core project team.
• Accountable for strategic development and execution of clinical studies aligned with contracts, optimizing speed, quality, and cost; ensure consistent use of study tools, training materials, and compliance with system updates, standard processes, policies, and procedures.
• Serve as primary project oversight and/or contact with customers; own relationship with key customer contacts; communicate/collaborate with IQVIA Business Development representatives as needed.
• Set objectives for the core project team according to contract, strategy, and approach; assess performance, provide feedback, and lead the team.
• Collaborate with other functional groups to support milestone achievement and manage study issues and obstacles.
• Monitor progress against contract and proactively prepare/present project information to internal and external stakeholders.
• Supervise problem solving and resolution efforts, including risk, contingency, and issue management; develop proactive contingency plans to mitigate risks.
• Coach and/or mentor junior team members on project delivery, planning, project review, risk management, and problem solving to ensure global alignment of work practices.
• Achieve project quality by identifying and proactively managing quality risks and issues; respond to issues raised by project team members and implement corrective and preventative action plans.
• May participate in executive committees as part of program leadership.
• Ensure financial success of the project, including optimal resource management to meet goals and profitability; forecast and identify opportunities to accelerate activities and bring milestones and revenue forward.
• Identify changes in scope and manage the change control process, securing customer agreement to financial and milestone updates as necessary.
• Identify and communicate lessons learned and best practices to promote continuous improvement; adopt corporate initiatives and serve as a change advocate when necessary.
• Provide input to line managers on project team members’ performance relative to project tasks; support staff development and mentor less experienced project team members on assigned projects.

Qualifications

• Bachelor’s degree in life sciences or related field.
• Requires advanced knowledge of the job area and broad knowledge of related areas, typically obtained through advanced education combined with experience.
• Requires 10 years of clinical research experience, including 6 years of project management experience, or equivalent combination of education, training, and experience.
• Knowledge of clinical trials, clinical trial conduct, and skill in applying applicable clinical research regulatory requirements (e.g., ICH GCP and relevant local laws, regulations, and guidelines).
• Broad protocol knowledge; therapeutic knowledge is desired.
• Good understanding of the competitive environment and ability to communicate/demonstrate value through IQVIA solutions.
• Strong written and verbal communication skills, including a good command of English; strong presentation skills.
• Strong negotiation and customer management skills.
• Ability to work through others to deliver results to quality and timeline metrics, monitor/manage performance, and provide feedback.
• Experience productively partnering cross-functionally and with customers to advance work effectively and efficiently.
• Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.
• Good understanding of project financials, including experience managing contractual obligations and implications.