Lead Clinical Study Manager
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Job Description
Lead Clinical Study Manager overseeing multi-site clinical trials and collaboration across teams for drug development initiatives. Focused on operational excellence and regulatory compliance.
Responsibilities:
- 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).
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
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