Clinical Project Management Director, Oncology - Durham, United States - IQVIA

Description

This role provides global operational leadership for the cross-functional delivery of assigned trial(s), within agreed timelines and budget and in alignment with all applicable SOPs and regulatory requirements, in alignment with the organizational and therapeutic area (TA) Clinical Team (CT)'s objectives.

Services/deliverables include the global accountability and operational oversight of both internally managed and outsourced trials, covering the end-to-end project management including start[1]up, execution, close-out, analysis and reporting.

In this role, you will be responsible for leading the cross-functional Trial Team and partners with all trial team members, building the trial operational plan and responsible for External Service providers' (ESP) contracts and budget.

• Services rendered will adhere to applicable SOPs, WIs, policies, local

• Leads the cross-functional Trial Team, tracking of project deliverables and timelines using functional planning tools and support. Proactively manages that trial deliverables and milestones are met. Identifies risks and ensures mitigation and contingencies are being initiated and followed through (including management of CAPAs).
• Accountable for delivery of global trials within agreed/projected life of trial budget. Ensures accurate trial budget management, updates for scope changes and reconciliation of assigned trials for both Out of Pocket (OOP) costs and FTE costs. Is responsible for overall contract management, including review & approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.
• Ensures that environmental analysis, protocol feasibility and country & site selection process is conducted within agreed timelines. Responsible to drive the final study placement and ensures alignment with and communication to the involved stakeholders, including TA and feasibility leads.
• Develops the trial ESP strategy for assigned trial(s) in line with the overall program ESP strategy.
• Is accountable for oversight of all external service providers for both inhouse and outsourced studies. Is responsible for vendor selection and set up, including scope of work and specifications in line with protocol requirements, budget and timelines. During execution, the GTL will ensure escalated vendor issues are appropriately resolved. For outsourced trials is responsible for management, including initiation of selection process, SOW development, budget and change orders and oversight of all deliverables outsourced to the CRO. Is primary point of contact for the assigned Project Director/Manager from the CRO responsible for the trial.
• Ensures that the trial is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes. Participates in preparation for, and conduct of, Health Authority inspections and internal QA audits. Ensures that the Trial Team operates in a constant state of inspection-readiness. Collaborate with Bioresearch Quality and Compliance liaisons to ensure quality oversight of assigned trial utilizing the available tools.
• Ensures appropriate trial-specific training is provided to the trial team members; in collaboration with the Study Responsible Physician (SRP). Oversee the Clinical Trial Manager (CTM) in the set[1]up and coordination of Investigator Meetings, if applicable.
• Ensures transparent status reporting information to relevant key stake holders in R&D.
• Ensure trial related issues (quality, timelines, budget, resources) are resolved within the function and/or within the Trial Team and if they can't be resolved within the function and/or Trial Team they are escalated to the GPL and Clinical Team level, as necessary. Manages timely and accurate documentation of issue escalation. Drive lessons learned initiatives at trial level during and after trial milestone completion; accountable for developing subsequent issue resolution and process improvements as required.
• Partners closely with the team members from Therapeutic Area, other GCDO functions, Clinical Supply Chain, Bioresearch Quality and Compliance Group, Clinical Business Operations, Finance, Project Management Organization, Regulatory and external partners, to influence alignment on issues and decisions affecting trial management, enabling successful trial outcome
• Program/TA specific activities (to be specified). Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document.

• Bachelor's degree or equivalent, preferably in Life Sciences.
• Minimum of 8 years of clinical trial experience in the pharmaceutical industry or CRO.
• Requires in-depth clinical research operational knowledge, strong project planning/management, communication and presentation skills. Must have the ability to manage all aspects of execution of a clinical trial. Experienced and proven track record of success in managing or leading global or regional teams in a virtual environment is required. Strong expertise in vendor management.
• Excellent leadership skills and proven ability to foster team productivity and cohesiveness.
• Specific therapeutic area experience and skills depending on the area of support.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.

We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.

IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status.

The potential base pay range for this role, when annualized, is $117, $263, The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time).

Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward.

Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

No matter your role, everyone at IQVIA, including our colleagues at Q2 Solutions, contributes to our shared goal of improving human health.