Scheduled Hours

40

Position Summary

Supports and assists the Sr. and Associate Directors with the operational planning and execution of multiple Phase II - III global/international studies, according to ICH-GCP and required regional regulations as applicable from protocol concept through the clinical study report.

Ensures completion of study deliverables, milestones, and objectives with guidance from the Associate and Sr. Directors while developing Therapeutic Areas knowledge and expertise through mentorship by the Associate and Sr. Directors, internal training, and external conference attendance.

Responsible for the overall management of assigned study conduct, including oversight of trial CROs and vendors, DIAN-TU Cores and Project Arm Leaders, and coordination of pharmaceutical partners, internal team, and core members and/or external vendors.

Independent management and oversight of functional area teams with little to no supervision required.

Job Description

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

Strategy/Strategic Planning

• Responsible for contribution and development of high-level trial strategy. 
• Develop and track against operational timelines.
• Independently strategizes on operations / problem-solving; and operational implementation of strategy.
• Assists the Sr. and Associate Directors with management of the full scope of study conduct in collaboration with Administrative Operations to ensure studies are conducted according to the Code of federal Regulations, Good Clinical Practices, ICH Guidelines, local regulatory requirements, and WU SOPs.
• Contributes to protocol synopsis development and Clinical Operations feasibility assessments.
• With guidance from the Sr. and Associate Directors, writing of study protocols, amendments and administrative changes based on approved protocol synopsis, in collaboration with trial pharmaceutical partners, Project Arm Leaders and Clinical Operations.
• Review and provide input to Clinical Study Report with guidance from the Sr. and Associate Directors.
• Facilitate and oversee all national level regulatory filings for the trial(s).
• Implements quality oversight measures and processes for all areas of the trial(s) as needed.
• Identify resource issues and escalate to DIAN-TU PI/Director, Clinical Operations Sr. and Associate Directors and/or Administrative Director.
• Provides input to problem-solving and implements corrective action plan when necessary.
• Participating and contributing member in DIAN-TU Clinical Operations leadership committee.

Pharma Partner Engagement

• Attend, support, and/or run higher-level pharma partner meetings and/or activities re: implementation of study drug arm within DIAN-TU including protocol and regulatory interactions.
• Collaborate with pharmaceutical partners to ensure appropriate and timely drug supply for assigned studies.

Functional Area and Vendor Management

• Independent management of external vendors including oversight of compliance and quality components of contracted scope.  Includes review of contracts, budgets, scope; and invoice review and approval.  
• Independently run and manage internal team, project, and/or functional areas within the trials; including collaboration with other DIAN-TU Cores.
• Participation in the selection of CRO and all clinical vendors and cores/components (e.g., biomarkers, imaging, data management) for assigned studies.
• Management and oversight of vendors/subcontracts (biomarkers, imaging, data management) which includes communicating expectations and timelines, ensuring deliverables are on time, with no quality issues.
• Assist Finance and Administrative Operations with development, negotiation, and execution of vendor and investigational site contracts.
• Ensure training of Project Arm Leaders, CRO, vendors, all performance sites and DIAN-TU Cores/Components on the protocol and expectations of the study.
• Responsible for identifying vendor, CRO, performance site, Project Leader, and/or collaborator issues and bringing to the attention of the Clinical Operations Sr. and Associate Directors, DIAN-TU PI/Director, Associate Director or Medical Director, and/or Administrative Director for discussion.
• Collaborates with all relevant groups (trial pharmaceutical partners, Project Arm Leaders, Administrative and Clinical Operations, Cores/Components, CRO, vendors, performance sites) to develop and manage clinical project timelines.
• Partners with Administrative and Clinical Operations personnel, Project Arm Leaders and CRO, where applicable, to resolve performance site issues.
• Partners with Administrative and Clinical Operations personnel, Project Arm Leaders and CRO and/or vendors (biomarkers, imaging, data management) for resolution of corrective actions as a result of QA audit and/or regulatory inspections.
• Escalate issues as appropriate for medical monitoring, safety, and exemptions/deviations, trial-wide GCP compliance at the sponsor, vendor, and site level, etc.
• Coordinates meetings with study team members as appropriate for the project.
• Planning and participation in investigator meetings in collaboration with all cross-functional team members.

Personnel Management

• Strong managerial skills and successful in leading not only direct reports but also functional area teams for operational execution.
• Mentor or supervise CTM and/or lower positions; has direct reports.
• Participating and contributing member of the Clinical Operations Leadership Committee.

Administration

• Manages timelines and prepares and maintains project tracking system with current study status and provide accurate progress reports on assigned studies as requested.
• Disseminates clinical project communication to all functional groups as appropriate.
• Maintains all documents related to the project and uploads documents to the appropriate location for maintenance and storage.
• Serve on the SOP Committee and develop applicable SOPs and working practices relevant to regulatory sponsor oversight.

Other duties as assigned.

Preferred Qualifications

• MS, PharmD, or PhD preferred â“ preferably in a scientific discipline.
• Experience in implementation and project management in a clinical setting is desirable.
• CRA experience and practical experience in protocol development (study design) and a good understanding of the operational execution of clinical protocols.
• Good comprehension of drug development and clinical trial methodology.
• Good understanding of GCP/ICH/FDA requirements and an ability to assess compliance to these guidelines.
• Willing to travel as necessary (i.e., investigator meetings, seminars, or company meetings etc.).
• Able to exercise good judgment to maintain confidentiality and ensure integrity of data.
• Able to work effectively in a team environment and be flexible to contribute to the needs of the group.
• Knowledge and Skills Communication skills - ability to be clear, direct, and tactful when communicating.
• Basic business and medical writing skills for protocols amendments, study summaries, and progress reports.
• Ability to organize and manage multiple vendors participating in clinical studies.
• Ability to prioritize work effectively to meet timelines.
• Budget Management - ability to develop a study 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 study-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 study.
• Good judgment, professionalism and independence are needed in interfacing with staff, CROs, Project 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 study execution
• Ability to provide input to managing external vendor resources (biomarkers, imaging, data management) related to study conduct.

Required Qualifications

• Bachelor's degree or RN required.
• Minimum of 10+ yearsâ™ experience in clinical research and program management including leadership and management experience with 7-10 years managing global trials.

Grade

G17

Salary Range

$99,800.00 - $175,900.00 / Annually

The 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.

Pre-Employment Screening

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.

Benefits Statement

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.

EEO/AA Statement

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.

Diversity Statement

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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