Senior Clinical Trials Specialist; Biotechnology Oncology

Overview

SUMMARY/

JOB PURPOSE:

The Senior Clinical Trials Specialist, Clinical Operations, role coordinates the activities associated with the evaluation, initiation, and management of clinical trials. This role provides operational support to the Study Delivery Lead (SDL) by managing assigned study activities and clinical sites, providing CRO oversight, and maintaining accurate study documentation.

• Review study documents to manage clinical trials, determine operational risks, and develop mitigation plans to address risks proactively
• Responsible for clinical sites within assigned geographical region, and assist with managing/overseeing external vendors within a specific scope (e.g., Lab), as assigned by SDL
• Provide CRO oversight on activities related to site start-up and maintenance, including reviewing trip reports, protocol deviations, data review, etc.
• Participate in meetings with CROs and cross-functional study teams to proactively work to mitigate project risks and resolve issues
• Assist with review and development of study documents and plans (e.g. Protocol, Informed Consent Form (ICF), Vendor Oversight Plan, eCRF Guidelines, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specifications, User Manuals)
• Review compound-specific ICF and develop study-specific ICF templates
• Assist Study Delivery Team (SDT) and CRO in feasibility assessments and site selection
• Responsible for study start-up activities and tracking study metrics (e.g. ICF review, Investigator/site performance, recruitment, and regulatory documents)
• Assist with protocol and study-specific training with vendor(s), site personnel and clinical sites
• May coordinate the preparation, conduct, and presentations at Investigator Meetings
• Review monitoring visit reports for completeness, accuracy, and adherence to the protocol
• Coordinate clinical drug/supply reconciliation with oversight of CRO and site reconciliation
• May conduct UAT for EDC / IRT and data listing review of EDC data for analysis
• Compile and review appendices for preparation of clinical study reports
• Review and/or create study documents (e.g. newsletters, and various study / site trackers)
• Assist in the coordination of Study Delivery Team (SDT) meetings, prepare agenda, draft and finalize minutes, and track action items to completion
• Maintain internal document management system and submit to TMF ensuring Regulatory and Essential/Important documents, and communication are filed timely and appropriately
• May assist in materials preparation for strategic governance discussions as required

None

• BS/BA/BSN in biological sciences or related field and a minimum of 5 years of related experience; or,
• MS/MA/MSN in biological sciences or related field and a minimum of 3 years of related experience; or,
• Equivalent combination of education and experience.

• Typically requires a minimum of 5 years of related experience in life sciences, including 3 years in experience in clinical research

• Working knowledge of clinical trial databases (e.g. EDC, CTMS, eTMF) and interactive response technologies (e.g., IWRS, IXRS), including report generation
• Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study-specific procedures
• Experience with development of prospective site-selection criteria
• Familiar with medical terminology, and basic concepts of clinical research
• Ability to deal with time demands, incomplete information or unexpected events
• Experience in interactions with outside vendors, e.g., CROs and contract labs
• Demonstrated ability to write and present clearly using on scientific and clinical issues terminology
• Applies technical standards, principles, theories, concepts and techniques
• Advanced computer skills
• Good organizational and planning skills
• Strong interpersonal skills and communication skills (both written and oral)
• Ability to work effectively in a team/matrix environment
• Ability to understand technical, scientific and medical information
• Demonstrated…