Sr Dir, Clin Project Mgmt, TMF - (R1030144) in United States at IQVIA™

Date Posted: 7/19/2018

Job Snapshot

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.


•         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
•         Support / represent the VP, Client and Business Operations  and PL Leadership Team in other areas, special projects, task forces, etc. as requested
•         Member of Project Leadership CBO leadership team
•         Member of Project Leadership Extended Leadership Team
•         Work closely with stakeholders across TMF leadership, RBUs, and other IQVIA delivery teams.
DTE Lead:
Lead the DTE team and oversee the strategy to implement DTE across Project Leadership and Operations.
•         Work with DTE CML team to align short and medium term strategy with internal and external customers
•         Identify and implement RBM support strategy for existing and potential top 15 customers (supporting DTE CORE initiatives)
•         Lead a team of individuals focused on driving DTE operational performance and providing proactive advisory support to the PL business lines. Embedding established best practices across a number of strategies targeted at improving execution
•         Sit on Customer JOCs, to drive RBM alignment with customers for the benefit of Clients and IQVIA
•         Evaluate impact of risks, develop and implement quality and risk management plans for minimizing impact on project objectives and deliverables
TMF Health Lead:
Lead the TMF Health Team to ensure delivery of the TMF Health Strategy plan:
•         Implement the HealthCheck tool across selected DIA e-TMF projects
•         Identify and develop materials to support TMF understanding / knowledge as required
•         Work with key stakeholders across functions to deliver TMF trainings as relevant
•         Review TMF processes and update associated SOPs as needed
•         Conduct TMF Health Effectiveness Checks on the TMF Global CAPA
•         Drive completion of the TMF Targeted Quality Reviews
•         Deliver MHRA CAPA within timelines and support development of MHRA quarterly update reports
•         Oversee TMF reporting and compliance tracking for key stakeholders
•         Assess usage of repositories that may impact TMF eg Sharepoint
•         Attend client meetings as required to support TMF discussions, understanding and activity
•         Attend internal meetings, forums etc to ensure key stakeholders updated and informed on TMF activity and priorities
•         Contribute to TMF CAPAs as required and develop preventative actions in capacity as Process Owner
•         Drive TMF Composition goal across Clinical Operations (quality, timeliness and completeness)
•         Support TMF inspections/audit preparations
•         Line Management of the TMF Health Team
Quality Lead:
Line Management of the Quality Team to deliver the following:
•         Collaborate with Quality Leads within TA, QA and QM to support compliance to CAPA targets
•         Collaboration with Process Owners, QA and SOP management team to ensure timely updates to SOPs
•         Oversee PMAPs to ensure correct owners and accurate maintenance
•         Provide information/data for RFP/RFI and audits as required and seek for SME input as needed
•         Support ad hoc quality initiatives
RCoE Lead:
Deliver appropriate and tailored resourcing strategy for Project Leadership including:
•         Set direction and over Line Management of the RCoE team
•         Establish strong relationships with key stakeholders to ensure effective and efficient resource management across each TA, the PMA Support Group and GRSU
•         Provide accurate resourcing forecasts detailing headcount, supply, demand, backlog to enable robust hiring decisions

Job Requirements

• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
• Excellent communication and interpersonal skills, including good command of English language
• Excellent organizational and problem solving skills
• Effective team-management skills

• Effective mentoring and training skills
• Ability to balance operational and strategic priorities
• Excellent customer service skills
• Good judgment and decision making skills
• Good understanding of other Quintiles functions and their inter- relationship with Clinical Project Management
• Strong software and computer skills, including MS Office applications
• In depth technical and/or therapeutic expertise and knowledge of study, project and drug development processes
• Knowledge of project financial tracking and accounting methods and skill in applying them
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Bachelor's degree in life sciences or related field and 15 years’ clinical research experience including 9 years’ leadership experience, including multi-regional and global focus; or equivalent combination of education, training and experience.
• Extensive use of keyboard requiring repetitive motion of fingers.
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
• Regular sitting for extended periods of time.
• May require occasional travel.
Proven ability to work through others to deliver results to the appropriate quality and timeline metrics
EEO Minorities/Females/Protected Veterans/Disabled

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.

Job ID: R1030144