Clinical Program Manager - Project Planning & Program Coordination (Sponsor Dedicated) at IQVIA

Reading, England, United Kingdom

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Clinical ResearchIndustries

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 operational stages

Responsibilities

Support Global Program Leaders (GPLs) in management of a Clinical Team to meet agreed upon deliverables as outlined in the CompoFund Development Plan (CDP)
Understand the drug development process to deliver a clinical program according to quality, timelines, and budget in close partnership with the GPL, Clinical leader, and Project Management Lead (PML)
Manage external partners and non-vendor relationships
Manage stage gate activities for the TA governance (such as writing memos and facilitating meetings)
Liaise with responsible functions for clinical supplies needed for the program
Address Urgent Safety Measures for the team
Provide support for financial and timeline planning
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
Ensure services 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
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 related 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

Skills

Project Planning

Program Management

Clinical Development

Timeline Management

Budget Forecasting

Resource Planning

Portfolio Management

Stage Gate Management

Financial Reporting

PLW

mCTMS

FTE Forecasting

Scope Control

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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