Description
Duties:Ensure improvement methodology and tools are utilized effectively to maximize benefits.
Deliver project goals on budget and on schedule.
Develop conceptual customer needs into an approved project charter.
Analyze business, process and systems performance, and identify improvement
Sponsor Product Innovation Management team is tasked with identifying novel new approaches to designing and executing clinical trials faster, better and cheaper.
The Clinical Project Manager through appropriate leadership, direction and operational expertise, will lead the development and execution of several clinical trial pilot experiments that are a subset of under Sponsor Conduct Portfolio:
The Sr. PM will represent the Innovation projects at the Innovation Conduct Core Team.
Develop program timelines and budgets and manage variance
Provide strategic, operational input to experiment/pilot plans and lead small nimble innovation teams/vendors to ensure effective development, implementation and execution of all clinical trial experiments within agreed timelines, resources and budget
Develop and present operational plan to management review bodies
Identify program risks and develop and implement mitigation strategies for assigned programs
Define the resourcing and outsourcing strategy needed as well as participate in idea assessments.
Work collaboratively, effectively, and efficiently with all internal and external partners and stakeholders.
Partner with Innovation Management and business functions to identify strategic business needs to support the experiments.
These responsibilities include: Create an environment supporting innovation and smart risks to help the experiment teams continuously evolve, improve and excel. Lead the creation and implementation of robust experiment plans that explore and assess new approaches.
Requirements:
10+ years experience of clinical and drug development, including 5+ years of clinical trial management experience
3+ years of clinical program management experience.
Experience in process improvement and innovation preferred.
Bachelor's Degree or equivalent required (scientific or healthcare discipline preferred).
Working knowledge of international regulatory and ICH GCP guidelines
Demonstrated understanding, knowledge, and experience of drug development in a complex setting. Cross-functional industry experience is helpful.
Demonstrated experience in various therapeutic areas
Strong analytical and strategic agility skills
Excellent planning and organizational skills
High level of initiative and ability to work independently
Exceptional leadership skills, including motivation and delegation
Highly effective team player and exceptional interpersonal skills
Strong financial acumen with experience managing clinical program budgets
Proven ability to implement and manage a clinical program (i.e. a series compromising a clinical development plan)
Ability to drive, encourage and support innovation.
Ability to navigate through ambiguity and drive for action despite limited resources.
Design Thinking and User Centered Design methodologies are helpful but not required.
Demonstrated ability to challenge established practices and concepts
Highly effective verbal and written communication and influencing skills in English.
Ability to persevere through rejection and failures.... focused on learnings and not outcomes