Clinical Trail Manager (FSP)

Parexel FSP are currently recruiting for an Experienced Clinical Trial Manager to join our team. In this role you'd be single sponsor dedicated to one of our key oncology sponsors. In this role you'll be responsible for leading regional clinical trials, with a focus on providing oversight management for our sponsors CRO vendors.

The role:

The Senior Clinical Trial Manager is the Regional Lead responsible for the coordination of clinical operations required to initiate, execute and complete clinical trials to drive on-time delivery of clinical trial milestones.

Responsibilities:

Acts as Regional Protocol Lead. Serves as main point of contact for clinical site management. Collaborates with internal team members, Contract Research Organizations (CRO), vendors and sites. Assists with design and review of protocols/informed consent forms (ICFs) and other study documents. Leads in identification, evaluation, and selection of clinical trial sites. Coordinates and manages vendor processes. Accountable for tracking of ancillary and investigational supplies, specimens and/or imaging. Facilitates communication between sites and the sponsor’s cross-functional staff. Leads functional teams within Regional Clinical Trial Operations Accountable for completeness of Trial Master File (TMF). Works closely with quality function to ensure inspection readiness. Supports audit and/or inspection activities. Primary point of contact for CRO activities. Ensures training compliance of all staff. Contributes to process improvement initiatives and departmental projects. Performs all duties and responsibilities in accordance with Code of Federal Regulations (CFR), International Council for Harmonization/Good Clinical Practice (ICH/GCP) Guidelines, SOPs, and other applicable guidelines. QualificationsSkills and Experience

Minimum of 5 years of relevant clinical trial management experience. Oncology clinical research experience is preferred. Global Phase I-III trial Management experience. CRO management experience. Experience managing large teams (direct or dotted line reporting). Excellent leadership, communication, and organizational skills. Ability to proactively handle multiple tasks, manage a diverse range of functional activities and solve problems simultaneously. Strong communication and inter-personal skills. Highly responsive and proactive, a team player. Thorough knowledge of CFR and GCP/ICH requirements as well as European Clinical Trial Directive. Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (eg, CTMS, EDC and eTMF).

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