The VP of Conduct Delivery, Clinical Trials will have broad therapeutic knowledge leading the multifunctional study management team. The study management team is collectively responsible for planning, solutioning, executing, and close-out of clinical studies, within the scope of the client agreement. In doing so, the VP of Clinical Development, Clinical Trials will oversee all operational aspects of clinical trials according to and in compliance with corporate and project Standard Operating Procedures (SOPs).
Manage all aspects of clinical operations for assigned project(s)
Lead the cross-functional Trial Team; tracking of project deliverables & timelines using functional planning tools and support
Proactively ensure that trial deliverables and milestones are met
Identify risks and ensures mitigation and contingencies are being initiated and followed through (including management of CAPAs)
Ensure delivery of trials within the agreed/projected trial budget
Ensure accurate trial budget management, updates for scope changes and reconciliation of assigned trials for both Out of Pocket (OOP) costs and FTE costs
Be responsible for overall contract management, including feasibility analyses in collaboration with CTS Business Development / Clinical Trial Strategy, review & approval of external service provider (ESP) contracts, change orders and ensure services are delivered per contract
Ensure that environmental analysis, protocol feasibility and country & site selection process is conducted within timelines
Be responsible for driving the final study placement, and ensure alignment with and communication to the involved stakeholders
Develop the trial ESP strategy for assigned trials in line with the overall program ESP strategy
Be accountable for oversight of all external service providers used for the trial for both in house and outsourced studies
Ensure selection, and set up, including scope of work (SOW) and specifications are in line with protocol requirements, budget and timelines.
Ensure Trial is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes
Participate in preparation for, and conduct of, Health Authority inspections and internal QA audits
Ensure that the Trial Team operates in a constant state of inspection-readiness
Collaborate with Quality Management & Compliance liaisons to ensure quality oversight of assigned trials utilizing the available tools
Ensure Trial Team members have received the appropriate trial-specific training.
Minimum of 8-10 years clinical trial management experience in the pharmaceutical industry or CRO
Specific subject matter expertise in all aspects of BioPharmaceutical clinical development and clinical trial operations/delivery
Knowledge of field organizational strategies - Ability to adapt to a rapidly changing work environment, managing competing priorities
Extensive knowledge of clinical research - understand the drug development process, clinical research industry and the relevant environment in which it operates
Knowledgeable about the critical elements for success in clinical trials, with a history of participation in and contribution of these activities
Ability to review protocols and assess the risks of programs and projects
Seasoned healthcare professional with significant experience interacting with senior business leaders, including c-suite
Able to see where the market, competition and industry are going, and create a strong vision for where the product needs to be to win the market and customers. Possess financial literacy with an appreciation for what drives enterprise value
Medical and scientific knowledge preferred
Bachelors degree required
Masters degree preferred
At CVS Health, we are joined in a common purpose: helping people on their path to better health. We are working to transform health care through innovations that make quality care more accessible, easier to use, less expensive and patient-focused. Working together and organizing around the individual, we are pioneering a new approach to total health that puts people at the heart.
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