Job Description

TheClinicalTrial Manager - Contractor(CTM)will provide clinical study supportto the Clinical Program Manager/Study Management Team Lead (SMTL)forone or more clinical studies, ensuring efficient delivery of clinical trials in a matrix environment. Key accountabilities include assuring successful conduct of clinical studies consistent with applicable regulations, guidelines and procedures, as well assupportingclinical project timelines, contracts, budgets, vendor management, invoicing, accruals,oversightmonitoringvisits, meeting milestones and deliverables, and internal/external communications.

Responsibilities

• Day-to-day management of assigned operational aspectsof low to medium complex clinical trials, including but not limited to vendor/ laboratory management, oversight of clinical sites, etc.
• Obtains and reviews all required essential documents necessary for study/site initiation
• Maintains/filesaccurate and timely sponsor/site correspondence and communication. Prepares and presents project progress reports
• Manages and tracks patient enrollment, site performance and monitoring metrics
• Performs tasksin accordance with ICH GCP, regulations, theprotocol,andcompany SOPs/Policies
• Supports the development and review of clinical study plans, presentations or study-related documents
• Support in the development and design of CRFs, including participating in the EDC and IXRS specification process and UATon related systems
• Assists with set-up of central labs and study vendors as required, including liaising withClinicalProgram Manager and CRO to ensure site training and timely initiationof clinical study sites
• Performs in-house review of clinical data listings for completeness and accuracy and escalate issues to theClinicalProgram Manager, as needed
• Works closely with data management leadto performdata cleaning activities with cross-functional team
• May lead and coordinate protocol deviation reviewand documentation
• Manage clinical monitoring activities and the overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics
• May perform accompanied site visits with CROSite Monitorsto ensure correct study procedures according to SOPs and protocol procedures, review of routine regulatory documents/files in compliance with protocol, regulatory requirements,site and CROSOPs, and study plans, as required
• Reviews monitoring trip reports and track resolution of all action items
• Participates in the selection, training, and evaluation of study personnel (vendor, CRO, internal)
• Assists with providing oversight of CROsandvendors
• Coordinates with CRO andSMTLin clinical siteoversight, data entry timeliness, assists with resolving site issues
• Assists with set-up and review of clinical TMF
• Organizes and manages internal team meetings, investigator meetings, and other trial­specific meetings, as requested
• Contributes to development and review ofclinical trial documents such as clinical protocol, informed consent form(s), patient facing materials,etc.
• Provides support in the development and management of vendor scope of work (SOW) per contract, quality, budget, and detailed timelines including investigator and vendor payments, as applicable
• Recommendandimplementinnovative ideas to increase efficiency and quality of program management activities
• Contributes to process and departmentaland cross-functionalimprovement activities

Qualifications

• Bachelor’sdegree,preferablyin a scientific field
• 5+ yearsofrelatedindustryexperiencein the pharmaceutical industry or equivalent,plus 2+years of trial management experience,preferably inoncology
• Demonstrates core understanding ofclinical trial relatedterminologyand activities
• Thorough understanding ofICH GCP guidelinesand Code of Federation Regulations
• Understanding of clinical trial processes from study start-up through study closure
• Ability to establish priorities, sense of urgency and collaborate (interpersonal, relationship management) with the study team, cross functional team members and external partners/vendors
• Excellent planning and organization skills
• Self-motivated,assertive,and able to function independentlyandas part of a team
• Strong interpersonal and negotiation skills as well as strong verbal and written communication (including presentation of materialsto internal teams and external partners)
• Excellent IT Microsoft skills and experience using clinical trial management web-based systems (i.e. EDC, IRT, CTMS, eTMF,etc.)
• Ability and willingness to travel 10-20% (domestic and international)

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