Job Description

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 CompoFund 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:

Develop

initial high-level study cost estimates

for new study concepts to support early planning and decision-making. Partner with

TDLs and TDMs

to ensure timelines, resources, and operational drivers are accurately represented in

planning tools (PLW)

. Provide

portfolio-level insights and narratives

to senior management (TA Leads, PDLs) to inform strategic decisions. Create, manage, and maintain

study schedules in PLW

for sponsored and collaborative studies; support OOPs management through First Patient In (FPI). Assure

clinical timelines in PLW

align with mCTMS and latest assumptions; ensure proper resource demand is reflected. Develop

budget, timeline, and FTE forecasting scenarios

in PLW, including situational operational scenarios. Collect, consolidate, and report

financial, timeline, and resource data

for governance approvals and external funding partnerships; manage scope control, FTE, and OOP variances. Provide

portfolio data insights

to TA Leads and PDLs for governance and strategic planning. Support

Finance, Business Partners, and Commercial stakeholders

with accurate data and operational inputs. 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.

Requirements:

BS degree or equivalent, in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy). 6-8 years clinical trial management experience in the pharmaceutical industry or CRO. Specific therapeutic area experience. Strong working knowledge of ICH-GCP, local laws and regulations. Superior clinical research operational knowledge. Proven track record in successfully managing various aspects of trials from start-up to database lock and trial closure. Demonstrated effective leadership to proactively drive the Study Management Team through key stages of trials, as well as delegation skills. Effective leadership skills and ability to manage multiple stakeholders. Proven ability to lead a team through formation stages, up to operating as a high performing team. Experience and ability in coordinating global or regional teams in a virtual environment. Proven ability to foster team productivity and cohesiveness. Experience and ability in coordinating global teams in a virtual environment for a minimum of 2, preferably 3 years. Proven experience in proactive planning, risk mitigating and gaining team consensus on updated plans during the project lifecycle. Strong project planning/management. Independent complex decision making. Solution oriented and proactive risk identification and mitigation. Strong IT skills, including knowledge of standard Microsoft applications, Trial Master File, Clinical Trial Management System, and willingness to learn new systems. Monitoring experience is recommended, or other relevant experience should be considered, such as data management or central monitoring. Proficient in speaking and writing local country language and English. Effective verbal and written communication skills leading to successful team collaboration Strong decision making. Solution oriented. Strong analytical skills, and simultaneously demonstrates the ability to manage ambiguity when limited information is available. Experience in developing presentations and presenting key information to stakeholders. Ability to understand and competently plan and have oversight of country and select vendor budgeting processes, i.e. Understand and be aware of country Out of Pockets (OOPs) and FTE cost drivers.

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