Lead Clinical Study Manager (Lead CSM)/ Clinical Operations Lead

Why RTI

RTI International is an independent, scientific research institute dedicated to improving the human condition. Our vision is to address the world's most critical problems with technical and science-based solutions in pursuit of a better future. Clients rely on us to answer questions that demand an objective and multidisciplinary approach—one that integrates expertise across social, statistical, data, and laboratory sciences, engineering, and other technical disciplines to solve the world’s most challenging problems.We believe in the promise of science and technical solutions, and we push ourselves every day to deliver on that promise for the good of people, communities, and businesses in the US and around the world. If you are looking for the opportunity to make a real difference, RTI is the place for you.

About the Hiring Group

RTI International, an independent nonprofit research institute dedicated to improving the human condition, is seeking a Lead Clinical Study Manager (Lead CSM)/Clinical Operations Lead to join our team. The ideal candidate will be highly motivated, results-oriented, and collaborative with experience leading multi-site clinical trial operations and drug development initiatives.

The Lead CSM will serve as the operational lead for clinical trials, including study planning, budget and resource management, and oversight of project vendors and subcontractors, as applicable. Focused on operational excellence, this person will work closely with Project Leadership to lead a cross-functional study team to ensure the timely conduct of high-quality clinical trials in accordance with study protocols, Good Clinical Practice, Standard Operating Procedures, and applicable regulations.

This is 6-month contract position with potential for extension or transition to regular employment. 

What You'll Do

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, through 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.
• Performs site and study management and collaborates with 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.
• Manages clinical site budgets and contracts for assigned clinical trials.
• Works with Project Leadership and partners 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.
• Responsible for oversight of site monitoring activities.
• 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 the development of study plans, manuals and study specific documentation including informed consent forms.
• Assist in the preparation of study protocol(s), informed consent documents, clinical study reports, clinical sections of IND applications, IND annual reports, etc.
• Ensures trial team members are trained on protocol and study specific procedures.
• 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.

What You'll Need

Typical Education & Experience 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.

Skills & Abilities:

• Must have strong knowledge of FDA-regulated clinical trial drug development processes, clinical trial study design, study planning and management, and monitoring.
• 4+ years of FDA-regulated clinical trials experience, including CRA/field monitor in pharmaceutical, biotech or CRO setting; 2 + years with a sponsor organization a plus.
• Previous clinical site level trial management experience is a plus.
• Minimum of 4 years' experience in the planning, launching, monitoring, 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.

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EEO & Pay Equity Statements

For San Francisco, CA USA Job Postings Only: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Further information is available here.

RTI accepts applications to our job openings from candidates with criminal histories or conviction records in accordance with all applicable laws, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

For Applicants in Massachusetts Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

The anticipated pay range for this role is listed below. Our pay ranges represent national averages and may vary by location as a geographic differential may be applied to some locations within the United States. RTI considers multiple factors when making an offer including, for example: established salary range, internal budget, business needs, and education and years of work experience possessed by the applicant. Further, salary is merely one element to our offer.

At RTI, we demonstrate our commitment to rewarding individual and team achievement through a total rewards package. This package includes (among other things) a competitive base salary, a generous paid time off policy, merit based annual increases, bonus opportunities and a robust recognition program. Other benefits include a 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, an employee assistance program, and numerous other offerings to support a healthy work-life balance.

Hiring Salary Range