Senior Clinical Study Manager

The Sr. Clinical Study Manager is at the heart of our Evidence Generation activities and aligned to our Cultural pillars of Go Beyond, Do What Matters Most and Keep it Human. The role provides operational leadership to the Clinical Study Team and is responsible for the planning, management, execution and delivery of the trial according of the study to timelines, budget and quality. The role will require a robust use of project management tools and operational practices.

Exhibits strong study operational strategy to plan and oversee execution of assigned studies, supporting clinical strategy defined in the Non-Clinical & Clinical Development Plan
Study Team Leader and primary operational contact for 1-3 trials of average design and protocol complexity, including clinical trials, behavioral testing, and decentralized/virtual trials.
Has the ability and agility to manage the delivery of any types of studies (complex/unusual study designs, new indications, challenging regional environment and local regulations) and strategically influence the operational delivery
Responsible for the implementation, conduct and tracking of study trials in compliance with ICH/GCP and local regulations, company SOPs and written standards for the conduct of human subject research, study timelines, within budget and to project specifications. Provides operational and strategic leadership to assure successful delivery of trials. Deliver in alignment with CH expections and cultural pillars.
Oversight of clinical sites, CROs and vendor activities according to the Functional Service Provider (FSP) or Full-Service Outsourcing (FSO) models. Leads or participates in clinical site assessments.
Lead the coordination of cross-functional department activities to successfully achieve milestones and quality deliverables in study management, including but not limited to study start-up, recruitment, study conduct, and database lock and study close-out with risk and issue management and assurance of TMF inspection readiness.
Contributes to the plans and study documents from an operational standpoint, such as protocols, informed consent forms, monitoring plans, vendor contracts, clinical study reports, etc.
Acts as HBS custodian
Take on functional leadership responsibilities, providing expert consult for issue resolution, piloting new ways of working
Represents Clinical Operations in vendor and due diligence/audit activities, and provides subject matter expertise on implementing Good Clinical Practice, business improvement initiatives and change implementation.