Lead Clinical Study Manager

Role Overview

• Independently manages and provides guidance and oversight for all components of clinical trials, from protocol/manual of procedures development and investigational new drug (IND) application submission, protocol implementation and study enrollment, to clinical study report and publication.
• Proactively manages and leads a cross-functional study team, including risk identification and mitigation planning.
• Recommends and implements innovative processes to improve and positively impact clinical trial management and deliverables.
• Assist in the preparation of study protocol(s), informed consent documents, clinical study reports, clinical sections of IND applications, IND annual reports, etc.
• Responsible for the development of study plans, manuals and study specific documentation including informed consent forms.
• Performs study management and collaborates with site managers, data managers, statisticians, regulatory experts, pharmacovigilance team, site monitors, etc.
• Coordinates other vendors involved in the trial such as central lab/biorepository, specialty laboratories, electronic Clinical Outcomes Assessment (eCOA) systems, electronic data capture systems (EDC) and interactive response technology vendor (IRT).
• Acts as a cross functional liaison, communicating trial status and issues, to ensure trial plan aligns with program and client goals.
• Escalates challenges appropriately to resolve issues related to study protocols or processes.
• Responsible for creating and maintaining timelines, including aligning study start-up, enrollment projections, study conduct, and close-out activities with study and project goals, and using these timelines to track and manage trial progress.
• Responsible for managing trial and vendor budgets, including review of invoices for accuracy.
• Provides expertise in clinical site budget development and contracts for assigned clinical trials.
• Works with Project Leadership and the site management team to identify and assess feasibility of potential clinical trial investigators and sites.
• Develop trial-related training materials for study team members, external team members, and clinical staff.
• May participate remotely or virtually in site initiation/training visits.
• Works closely with the study team to develop trial associated clinical forms/data collection tools, including electronic case report forms and user acceptance testing, serious adverse event forms, etc.
• Works with outsourced or in-house data management groups to create and implement study-specific tools to ensure clean data, e.g., metrics reports, patient profiles, etc.
• Oversees the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participates in data reviews.
• Responsible for oversight of study Trial Master File (TMF) for inspection readiness.
• Collaborates with clinical quality staff to develop a quality plan, including audit readiness assessments for assigned clinical trials.
• Participates in the recruitment and onboarding process for CTMs and other clinical operations team members.
• Provides oversight and/or mentorship for less experienced staff.
• May lead or contribute to development of program wide processes and initiatives; contributes to the development of standard operating procedures (SOPs), templates and forms and processes.

Requirements

• Bachelor's Degree and 10 years of experience, Master's degree and 8 years of experience, PhD and 6 years of experience, or equivalent combination of education and experience.
• Relevant clinical research certifications (e.g., CCRA, CCRP) preferred but not required.
• Must have strong knowledge of clinical trial drug development processes, clinical trial study design, study planning and management.
• 4+ years of clinical trials experience, including Clinical Trial Manager (CTM) in pharmaceutical, biotech or CRO setting; 2 + years with a sponsor organization a plus.
• Previous clinical trial manager experience is a plus.
• Minimum of 4 years' experience in the planning, launching, managing and closeout of Phase 1-3 clinical trials conducted under INDs.
• Strong knowledge of CFR, ICH, GCP and GDPR/data privacy requirements.
• Experience with industry standard clinical trial data management systems, trial master files, clinical trial management system platforms.
• Previous participation in the successful set-up and management of CROs and associated vendors, (e.g., central labs, data management, eCOA) a plus.
• Ability to review and analyze performance metrics through various systems for assigned areas of responsibility including vendors; and drive actions toward improving results.
• Strong problem-solving skills with ability to anticipate issues and outcomes and respond strategically, proposing innovative “outside the box” solutions to challenges, including obtaining input from colleagues to derive solutions.
• Experience and competent at developing and delivering effective presentations in multidisciplinary settings.
• Excellent interpersonal and communications skills with the ability to work collaboratively as a member of a cross-functional team.
• Self-starter, comfortable and effective working in a hybrid work environment with department and cross-functional colleagues, and vendors based in different geographies.
• Strong attention to detail, and organizational and time management skills with ability to prioritize tasks to meet critical deadlines.
• Ability to prioritize urgent and important tasks and take necessary actions to inform/escalate to management and stakeholders as appropriate.
• Ability to utilize a wide range of computer applications and tools.
• Proficiency with MS Office Suite, Word, Excel, PowerPoint, SharePoint, TEAMs; Smartsheet and MS Project experience a plus.
• To qualify, applicants must be legally authorized to work in the United States and should not require, now in the future, sponsorship for employment visa status (e.g., H-1B visa status, etc).

Tech Stack

• Google Cloud Platform

Benefits

• competitive base salary
• generous paid time off policy
• merit based annual increases
• bonus opportunities
• robust recognition program
• competitive range of insurance plans (including health, dental, life, and short-term and long-term disability)
• access to a retirement savings program such as a 401(k) plan
• paid parental leave for all parents
• financial assistance with adoption expenses or infertility treatments
• financial reimbursement for education and developmental opportunities
• employee assistance program
• numerous other offerings to support a healthy work-life balance