Scheduled Hours
40
Position Summary
Project management in more than one area/aspect of a project. Demonstrated mastery of CTM/CTM I skill set and expectations.
Job Description
Primary Duties & Responsibilities
Strategy/Strategic Planning
- Contribute to strategic discussions, ideas, etc. and assist in carrying out its implementation.
- Contribute to the development of project and operational timelines. Expand knowledge and train on timeline development and management.
Participating and contributing member in DIAN-TU clinical operation leadership committee. Pharma Partner Engagement.
- Attend and participant in pharma partner meetings; speak to respective functional areas.
- Support and run pharma sub-team meetings; manage minutes and agendas for pharma meetings.
Functional Area and Vendor Management
- Manage vendors and compliance and quality of contracted scope with support/guidance from Sr. CTM or director-level.
- Strong grasp of vendor scopes and budget / contract although not independent; invoice review.
Manage functional areas with minimal support from Sr. CTM / director-level. Personnel Management.
- Manage team members at the project level based on responsible functional areas.
- Has direct reports.
- Participating and contributing member.
Other duties as assigned.
Preferred Qualifications
- Master’s degree.
- Experience at a CRO and/or pharmaceutical environment strongly preferred.
- Minimum of five or more years of 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.
- Possess 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.
- 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.
Required Qualifications
- Bachelor’s degree in related field or equivalent level of training and experience.
- Minimum of five to ten years’ experience in clinical/global trial.
Grade
G16
Salary Range
$96,000.00 - $169,300.00 / 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.
Questions
For frequently asked questions about the application process, please refer to our External Applicant FAQ.
Accommodation
If you are unable to use our online application system and would like an accommodation, please email CandidateQuestions@wustl.edu or call the dedicated accommodation inquiry number at 314-935-1149 and leave a voicemail with the nature of your request.
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
Personal
Up to 22 days of vacation, 10 recognized holidays, and sick time.
Competitive health insurance packages with priority appointments and lower copays/coinsurance.
Want to Live Near Your Work and/or improve your commute? Take advantage of our free Metro transit U-Pass for eligible employees. We also offer a forgivable home loan of up to $12,500 for closing costs and a down payment for homes in eligible neighborhoods.
WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%.
Wellness
Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more!
Family
We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We’ve got you covered.
WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us.
For policies, detailed benefits, and eligibility, please visit: https://hr.wustl.edu/benefits/
EEO/AA Statement
Washington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the University’s policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.
Diversity Statement
Washington University is dedicated to building a diverse community of individuals who are committed to contributing to an inclusive environment – fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.
