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Director, FSP Clinical Operations

Parexel International Corporation

United Kingdom - Any Region - Home Based

The Director, FSP Clinical Operations is responsible for the following:

• Direct line management of FSP Operations staff, oversight of Client accounts, as well as support of ExecuPharm (EP) FSP Operations business objectives.Responsible for execution and oversight of Program Management activities related to one or more programs. May serve as central point of contact (POC) for and between EP Senior Management and key Client personnel for contracted FSP Operations activities: Plans and manages logistics, infrastructure, and resources related to FSP services to meet the Client needs/timelines/deliverables. Collaborates with Client to implement and operationalize short and long-term strategies. Coordinates and manages resourcing process including hiring, selection, and onboarding/offboarding of Client-assigned staff. Develops and manages Communication and Escalation plans/process, as applicable. Oversees Client Governance as required; prepares/presents at meetings as applicable. Oversees performance management of Client-assigned staff who support contracted FSP activities and collaborates with FSP Operations Management to ensure Client assigned staff are technically proficient and able to satisfy Client expectations and deliverables. Manages compliance with Client Key Performance Indicators; utilizes EP/Client tools and systems to collect, track, analyze associated data. Leads Client specific FSP meetings with EP program team ensuring that contractual requirements related to FSP Operations activities are met and monitored on an ongoing basis. Oversees and/or manages issue escalation and resolution including CAPA development when necessary

Line Management Coaches, mentors, develops, and supports FSP Operations staff.

QualificationsMinimum BS or BA (biological sciences or nursing preferred) other qualification which will be reviewed during the hiring process to ensure equivalence. 7+ years of clinical operations experience and a minimum of 4 years of senior level line management experience. In-depth knowledge of overall drug development process and clinical trial operations with a comprehensive understanding of local regulations (i.e. FDA, EMA, etc.) and GCP/ICH guidelines. Previous experience working in a remote office environment and independently managing remote workers with ability to effectively manage a team and promote collaboration in a matrix organization Experience working in customer service/outsourcing model with experience in managing and forecasting resource allocation

Job posted: 2021-02-26

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