Leads and oversees the execution of clinical projects and research studies in accordance with global and local regulations to best meet customer needs while working toward organizational goals and strategies.
Description Manages the delivery of clinical research studies from initiation to closeout.
Ensures that quality deliverables are presented on time and within budget; coordinates workstreams and cross-functional project teams while monitoring the use of consistent tools and methodologies; identifies and evaluates potential project risks and develops mitigation plans; and serves as the primary point of contact with the project sponsor.
Clinical Project Management Directors direct and manage the team responsible for clinical delivery of complex; global full service, multi-regional studies and/or programs.
Has strategic decision-making responsibility for the project/program.
Responsible for direction and management of portfolios and/or accounts from operational perspective ensuring that studies and/or programs are delivered on time and quality resulting in strong financial performance and customer satisfaction and in accordance with SOPs; policies and practices from pre-award to close-out.
Focus on leveraging therapeutic expertise and IQVIAs suite of solutions to drive operational excellence and strategic leadership with our customers.
Essential Functions Contribute to the development of the project delivery strategy for Request for Proposals (RFPs).
Participate in bid defense preparations.
Lead bid defense presentations in partnership with business development for large, complex, multi-service, multi-region studies or programs.
Understand project strategy and operationalize the agreed upon approach.
Oversee the development of integrated study management plans with the core project team.
Direct the execution of clinical studies as per the contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
Recognize systemic issues at program or portfolio level and identify solutions with the project teams, recommend actions to improve efficiencies and oversee the implementation of best practices, address escalation items with the customer.; Set objectives of the core project team according to agreed upon contract, strategy and approach, effectively communicate and assess performance.
Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
Monitor progress against contract and prepare/present project information proactively to all stakeholders internally and externally.
Responsible for the management and delivery of large and/or complex studies or programs of studies.
May be responsible for portfolio management with one customer or therapeutic area.
Proactively manage strategic risk (positive and negative) and contingencies and lead problem solving and resolution efforts.
Achieve project quality by identifying quality risks and issues, responding to issues raised by project team members and planning/implementing appropriate corrective and preventative action plans.
Serve as primary project/program/portfolio contact with customer and own relationship with key customer contact(s), communicate/collaborate with IQVIA business development as necessary.
Drive consistency of operational delivery across customer’s projects/programs/portfolio.
Build the cross-functional project/program/portfolio team and lead their efforts, responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.; Responsible for ensuring the financial success of project/programs/portfolio.
Forecast and identify opportunities to accelerate activities to bring revenue forward.
Identify changes in scope and manage change control process as necessary, identify opportunities to increase scope to assist the Customers business needs.
Identify and communicate strategic lessons learned and best practices to promote continuous improvement.
Participate in, champion and adopt function and/or corporate initiatives, changes and/or special project assignments, act as a client liaison, departmental cross-functional liaison and/or change agent.
Provide input to line managers of their project team members’ performance relative to project tasks.
Recommend team members’ further professional development.
Support staff development.
Mentor less experienced project team members on assigned projects to support their professional development.
Qualifications Knowledge of clinical trials
– Knowledge of clinical trial conduct, and skill in applying applicable clinical Knowledge of clinical trials
– Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements, i.e.
ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct.; Knowledge of clinical trials
– Broad protocol knowledge, therapeutic knowledge desired.; Knowledge of clinical trials
– Good understanding of the competitive environment and how to communicate/demonstrate value through IQVIA solutions.
Communication
– Strong written and verbal communication skills including good command of English language.
Communication
– Strong presentation skills.
Problem solving
– Strong problem solving skills.
Leadership
– Ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback, experience productively partnering cross functionally and with customers to advance work effectively and efficiently.; Leadership
– Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.
Organization
– Planning, time management and prioritization skills Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances.; Prioritization
– Ability to handle conflicting priorities.
Prioritization
– Ability to work strategically to realize project goals, identifying and developing positive and compelling visions for the successful delivery of the project.
Quality
– Attention to detail and accuracy in work.
Quality
– Results-oriented approach to work delivery and output.
Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving.
IT Skills
– Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
Collaboration
– Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Excellent customer management skills and demonstrated ability to understand customer needs Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.
Cross-collaboration
– Ability to work across geographies displaying high awareness and understanding of cultural differences Good understanding of other IQVIA functions and their inter-relationship with Project Leadership.
Finances
– Good understanding of project financials including experience managing, contractual obligations and implications.
IQVIA Core Competencies
– Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).
Required Education & Experience Bachelors Degree in Life Sciences or related field Requires 12 years of prior relevant experience including minimum 8 years of project management or relevant functional experience OR equivalent combination of education, training and experience