This position will primarily support the Global Program Leaders (GPLs) in management of a Clinical Team to meet the agreed upon deliverables as outlined in the Compound Development Plan (CDP). Services include understanding the drug development process to deliver a clinical program according to quality, timelines, and budget in close partnership with the GPL, as well as with the Clinical leader and the Project Management Lead (PML) responsible at the Clinical Development Team (CDT) level. Services include managing external partners and non-vendor relationships, managing stage gate activities for the TA governance (such as writing memos and facilitating meetings), liaise with responsible for functions clinical supplies needed for the program, addressing Urgent Safety Measures for the team, and providing support for financial and timeline planning.

Deliverables:

• Services rendered will adhere to applicable Sponsor SOPs, WIs, policies, local regulatory requirements, etc.
• Manage Clinical Team (CT) agendas, information, documentation, and team communications to ensure timely and accurate dissemination of the CT strategy and operational status throughout the cross-functional team and between co-development partners and/or other external partners as applicable. Ensure documentation of team meetings, key decisions, action items, risk, and team communication.
• Partner with the GPL and GTL, as well as the program Coordinators and Finance to support continuous forecast for the program under that Clinical Team.
• Partner with cross-functional leads for the program within Global Development and outside of Global Development such as regulatory, finance, clinical supplies, Biomarker depts and Global Medical safety to ensure appropriate communication and escalations and resolutions around risks and issues are being shared when it comes to quality, timelines, and budget
• Manage the governance infrastructure and reporting with co-development partners and or other external partners as directed by the GPL.
• Manage clinical team governance deliverables partnering with the GTLs for trial level information.

Education and Experience Requirements/Qualifications:

• A minimum of a bachelor’s Degree or equivalent work experience is required, Post-Graduate degree in Project Management or business is preferred
• Professional Project Management certification is preferred
• A minimum of 5 years industry/CRO/business experience is required in clinical drug development and/or clinical operations, clinical R&D experience preferred.
• A minimum of 3 or more years’ experience in Project Management is preferred.
• Prior experience leading a cross-functional global teams is required.
• Prior experience working in a Pharma company
• Demonstrated ability to resolve conflict and influence teams without direct authority
• Successful experience in planning and management of governance bodies is preferred
• Proficient in MS Project is required

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com