Lead Clinical Study Manager
RTI International
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $120,000 - $147,000 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- The key deliverables for this role are the planning and execution of complex clinical trials in accordance with designated timelines and budgets.
- 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.
Benefits
- Competitive base salary
- Generous paid time off policy
- Merit based annual increases
- Bonus opportunities
- Robust recognition program
- Health insurance
- Dental insurance
- Life insurance
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial managementstudy designstudy planningdata analysisprotocol developmentrisk identificationdata cleaningbudget managementclinical trial phasesperformance metrics analysis
Soft skills
problem-solvinginterpersonal skillscommunication skillsorganizational skillstime managementcollaborationleadershipmentorshipstrategic thinkingattention to detail
Certifications
CCRACCRP