Position manages identification and placement of sponsor-initiated clinical trials, investigator requests for CCS services and CCS marketing initiatives. Supports the CCS Mission and CCS goals related to increasing clinical trial activity at WUSM.
The Clinical Trial Manager supports and assists in the operational planning, management and execution of multiple phase II/III international trials for the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) conducted in accordance with ICH/GCP and local regional requirements from protocol concept through clinical study report. This position contributes to the development of trial-related scopes of work, costs, timelines, metrics and deliverables. This position will ensure the completion of study deliverables, milestones and objectives through management of assigned study conduct including oversight of trial CROs and vendors, coordination of internal team and core members and/or external vendors, and providing support to trial teams.
Very busy office environment with frequent moderate/high pressure caused by deadlines. After hours and/or weekend responsibility due to urgent situations and international duties. Able to fly to various meetings (domestic and international) at investigator, pharma partner, trial, vendor or regulatory agency sites.
Primary Duties and Responsibilities
Management and oversight of CROs and vendors including but not limited to: data management (EDC), central lab, central read (MRI, ECG, etc.), IVRS/IWR, home health nursing network, clinical supplies packaging, global CRO (project management, monitoring, regulatory affairs), and pharmacovigilance.
Facilitate and oversee all national level regulatory filings for the trial(s).
Collaborate with all relevant groups: multiple pharmaceutical partners; Project Arm Leaders; the DIAN-TU Trial Cores: Biomarker, Biostatistics, Clinical, Cognition, Genetics, Imaging; Trial Project Leaders; CRO(s); vendor(s); investigational sites, and subject matter experts to develop and manage clinical project timelines.
Support full scope of study conduct (Clinical Operations) in collaboration with Administrative Operations to ensure the trial(s) are implemented and conducted according to the Code of Federal Regulations, Good Clinical Practices, ICH Guidelines, local regulatory requirements and WU SOPs.
Maintains all documents related to the project and uploads documents to the appropriate location for maintenance and storage.
Escalate issues as appropriate for medical monitoring, safety, and exemptions/deviations, trial-wide GCP compliance at the sponsor, vendor, and site level, etc.
Development of SOPs and working practices relevant to regulatory sponsor oversight.
Manages to and within timeline and prepare project tracking system with current trial(s) status and provide accurate progress reports on assigned trial(s) as requested.
Contribute to implementation of quality oversight measures and processes for all areas of the trial(s). Identification of trial issues or quality issues for escalation and remediation.
Coordinate regular meetings with study team members and cores as appropriate for the project.
Disseminates clinical project communication to all functional groups/cores as appropriate.
Provides input to problem-solving and implements corrective action plan when necessary.
Partners with applicable cores and/or CRO/vendor for resolution of corrective actions as a result of QA audit and/or regulatory inspections.
Contribute to protocol and amendment development and Clinical Operations feasibility assessments.
Collaborate with pharma partners to ensure appropriate and timely drug supply for assigned trial(s), including oversight of expiry, quantities, etc.
Planning and participation in investigator meeting(s) in collaboration with all cross-functional team members.
Ensure training of Project Arm Leaders, all clinical trial sites, vendors, and DIAN-TU Cores on the protocol and expectations of the trial(s).
Participation in the selection of CRO and all clinical vendors/components (biomarkers, imaging, data management) for assigned trial(s).
Partners with CRO and/or applicable team for resolution of recruitment and site performance issues.
Master's degree in business or healthcare.
Previous supervisory experience may be helpful.
High degree of diplomacy and professionalism in handling confidential information and maintaining productive relationships with CCS personnel, other WUMC personnel, external sponsors and other customers.
Independent judgement and decision-making a must in planning and executing programs and supervising/advising others.
RN, or equivalent extensive direct clinical trial work experience in industry-regulated environment.
Experience at a CRO and/or pharmaceutical environment strongly preferred.
Minimum of 5+ years' experience in clinical research, project/program, and vendor and management.
Experience in clinical trial start-up, maintenance and close-out.
CRA, CRC, or PM experience in protocol development (trial design) and a strong understanding of the operational execution of clinical protocols from a sponsor perspective.
Good comprehension of drug development and clinical trial methodology.
Proficient in ICH/GCP and industry-regulated IND trial requirements and an ability to assess compliance to these guidelines.
Ability to organize and manage multiple vendors participating in clinical studies.
Superior organizational and negotiation skills.
Strong leadership abilities.
Ability to prioritize work effectively to meet timelines. Must be flexible with the ability to rapidly and effectively respond to changing priorities.
Willing to travel as necessary (i.e. investigator meetings, seminars or company meetings, etc.).
Strong working knowledge and ability to exercise appropriate judgment to maintain confidentiality and ensure integrity of data and proprietary information.
Able to work effectively in a team environment and be flexible to contribute to the needs of the team.
Skillful communication - clear, direct, and tactful communication skills.
Basic business and medical writing skills required for pharma and site communication; protocol and amendment writing or review; study summaries; and progress reports.
Budget Management - ability to develop a trial budget to monitor and control expenditures; provides justification/rationale for budget variances.
Demonstrates basic presentation skills at Investigator or team meetings.
Analytical skills - ability to identify trial-related, CRO-related or site-related issues, determines the causes and possible solutions to the problem.
Responsible for resolving issues with study conduct with appropriate staff and CRO for a clinical trial(s).
Good judgment, professionalism and independence are needed in interfacing with staff, CROs, pharma partners, subject matter experts / thought leaders, study coordinators, and investigators.
Technical Competency - displays in-depth knowledge of clinical study procedures and maintains an awareness of environment as it affects clinical trial execution.
Proficient in Microsoft Office programs (Word, Excel, PowerPoint, Project, Publisher, Access, and Outlook).
Experience managing FDA-regulated phase II and III therapeutic intervention trials is strongly preferred.Ã¡ Global experience is desirable.
Prior coordinating and/or CRA experience is beneficial.
Neurology and/or Alzheimer's disease experience is highly desirable.
$69,600.00 - $108,000.00 / AnnuallyThe salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.
All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.
Washington University in St. Louis is committed to providing a comprehensive and competitive benefits package to our employees. Benefits eligibility is subject to employment status, full-time equivalent (FTE) workload, and weekly standard hours. Please visit our website at https://hr.wustl.edu/benefits/ to view a summary of benefits.
Washington University is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to an individualâ™s sex, race, color, religion, age, disability status, protected veteran status, national or ethnic origin, gender identity or expression, sexual orientation. Women, minorities, protected veterans and the disabled are strongly encouraged to apply.
Washington University is dedicated to building a diverse community of individuals who are committed to contributing to an inclusive environment â“ fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.
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