- Minimum of five (5) years of verifiable experience providing personnel for the same or similar kinds of project management positions.
- Experience with good documentation procedures and practices
- Experience and background in project management; PMP certification is highly desirable
- Ability to interface and work with others in a matrix management structured environment
- Interact with CSU research labs, contract manufacturing organizations (CMOs) and contract research organizations (CROs) to complete pre-clinical, and IND-enabling activities. Future work efforts may include interaction with labs to support Phase I production and clinical activities.
- Manage vendor contracting including MSAs, work orders, and invoices.
- Prepare RFPs and detailed itemized proposal comparisons.
- Ensure vendors stay on-task and complete contracted work in timely manner through regular conference calls.
- Conduct and coordinate review of technical documents.
- Working knowledge of FDA and EMA regulations and requirements.
- Collect information from vendors to support IND modules for drug substance, drug product, pharmacology and introductory material.
- Work with CSU regulatory support to ensure third-party reports are within protocol regulations and formatted correctly.
- Generate monthly status reports for all on-going activities.
- Prevent slippage from aggressive development timelines.
- Develop contingency plans to quickly and efficiently adapt to challenges that may arise.
- Create forward-looking Gantt charts and project plans to guarantee timely initiation and completion of activities.
- Provide strategies to reduce technical and logistical risks.
- Work independently and collaboratively in a matrixed environment.
- Interact with CSU/BioMARC leadership, laboratory and development staff, and purchasing and invoicing personnel to successfully communicate expectations and responsibilities and to promote awareness of ongoing activities and upcoming deliverables.
- Keep detailed records of all activities, data, and reports in central repository as directed by the CSU/BioMARC leadership team.
- Maintain organization of responsible areas of the central repository.
- Ensure necessary personnel have access to required documents.
- Must be willing/able to comply with FAR Clause , Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors.
- Must comply with the Special Terms and Conditions for CSU Federal Contracts posted as part of the bid packet at
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Project Manager - Fort Collins, United States - Colorado State University
Description
Posting DetailsPosition Information
Classification Title
Temporary Hourly
Employment Category
Temporary
Is this an Hourly position?
Yes
Work Hours/Week
18-20 Hours/Week
Overtime Eligible?
Yes
Position Location
Fort Collins, CO 80523
Does this position qualify for hybrid or remote work?
No
Description of Work Unit
The Microbiology, Immunology and Pathology (MIP) Department is comprised of over 400 individuals who share a common passion for solving some of the most important human and animal health problems today. Research programs include those related to mycobacteria, retroviruses, prions, and arthropod-borne infectious diseases, as well as the diagnostic investigation of naturally-occurring animal diseases. A leader in education, MIP provides the only microbiology undergraduate degree program in Colorado, a graduate program that provides training in a number of cutting-edge disciplines, and several specialized veterinary residency training programs.
Search Contact Email
,
Position Summary
The individual in this role will serve as a project manager and coordinator for an NIH/NIAID sponsored position related to the SolaVAX-CoV-2 Development program. The individual in this role will interface with investigators who are conducing pre-clinical work, clinical trial preparatory work and BioMARC staff involved in manufacturing of the vaccine candidate under this contract.
Position Minimum Qualifications
Working Title
Project Manager - Goodrich Lab
Posting Number
T
Department
Microbiology, Immunology and Pathology
Salary Range
$100, ,769 at full time rate
Employee Benefits
Visit CSU's Human Resources website for detailed benefit plan information for temporary employees in the following University benefit area:
Close Date
06/30/2024
Special Instructions to Applicants
References will not be contacted without prior notification to applicant.
Three (3) references including contact information from previous clients. At least one of the references must be from a client for whom the candidate filled a similar contract management position within the last 12 months.
Background Check Policy Statement
Colorado State University strives to provide a safe study, work, and living environment for its faculty, staff, volunteers and students. To support this environment and comply with applicable laws and regulations, CSU conducts background checks. The type of background check conducted varies by position and can include, but is not limited to, criminal history, sex offender registry, motor vehicle history, financial history, and/or education verification. Background checks will also be conducted when required by law or contract and when, in the discretion of the University, it is reasonable and prudent to do so.
EEO Statement
Colorado State University is committed to providing an environment that is free from discrimination and harassment based on race, age, creed, color, religion, national origin or ancestry, sex, gender, disability, veteran status, genetic information, sexual orientation, gender identity/expression, or pregnancy in its employment, programs, services and activities, and admissions, and, in certain circumstances, marriage to a co-worker. The University will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Colorado State University is an equal opportunity and equal access institution and affirmative action employer fully committed to achieving a diverse workforce and complies with all Federal and Colorado State laws, regulations, and executive orders regarding non-discrimination and affirmative action. The Office of Equal Opportunity is located in 101 Student Services.
The Title IX Coordinator is the Director of the Office of Title IX Programs and Gender Equity, 123 Student Services Building, Fort Collins, CO , ,
The Section 504 and ADA Coordinator is the Director of the Office of Equal Opportunity, 101 Student Services Building, Fort Collins, CO , ,
The Coordinator for any other forms of misconduct prohibited by the University's Policy on Discrimination and Harassment is the Vice President for Equity, Equal Opportunity and Title IX, 101 Student Services Building, Fort Collins, Co , ,
Any person may report sex discrimination under Title IX to the Office of Civil Rights, Department of Education.
Diversity Statement
Reflecting departmental and institutional values, candidates are expected to have the ability to advance the Department's commitment to diversity and inclusion.
Essential Job Duties
Job Duty Category
Vendor Management
Duty/Responsibility
Varies
Job Duty Category
Regulatory Affairs
Duty/Responsibility
Varies
Job Duty Category
Risk Mitigation
Duty/Responsibility
Varies
Job Duty Category
Teamwork
Duty/Responsibility
Varies
Job Duty Category
Record Keeping
Duty/Responsibility
Varies
Job Duty Category
Compliance with Regulations for Federally Funded Projects
Duty/Responsibility
Varies
References
Minimum References Required
3
Maximum References Required
3