Associate Project Manager II
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Job Location:
Austin, TX - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Work Schedule
First Shift (Days)Environmental Conditions
Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
Manages all aspects of assigned clinical trials involving patient and healthy subject populations in bothinpatient and outpatient settings. Acts as liaison between the Sponsor the Investigator and the researchteam. Ensures client requirements and specifications are communicated to the research teams and anyissues/questions raised by the research team or investigators are communicated back to the client forresolution.
Essential Functions and Other Job Information:
Serves as a primary point of contact for sponsors and the business unit for
clinical site related aspects of the study.
Collaborates with internal departments to ensure deliverables are met as defined
within the contract and study timeline.
Manages all clinical and administrative aspects of a clinical project including site level study set-up recruitment conduction and data collection.
Manages IRB submissions. including creation of study specific informed consent
forms SAE notifications and maintenance of the regulatory file and documents.
Collects feedback from various departments to create a risk register for each
study and maintains and updates the register throughout the study; works with
the Principal Investigator to ensure that a risk mitigation plan (RMP) is finalized
and reviewed by the safety committee prior to study conduct.
Works closely with finance department to manage fiscal aspects of study conduct
while meeting sponsor requirements and adhering to the protocol SOPs and
contract.
Provides vendor oversight when services are contracted.
Qualifications:
Education and Experience:
Bachelors degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to
2 years).
In some cases an equivalency consisting of a combination of appropriate education training
and/or directly related experience will be considered sufficient for an individual to meet the
requirements of the role.
Knowledge Skills and Abilities:
Knowledge of Phase I processes and strong knowledge of clinical study operations
Knowledge of FDA regulations and ICH GCP guidelines
Knowledge of budgeting/forecasting/planning projects
Solid computer skills with working knowledge of Microsoft Office applications
Good time management and multi-tasking skills
Excellent written and verbal communication skills
Demonstrated ability to prioritize workload and adapt to changing study needs
Demonstrated ability to act as a liaison between external and internal groups
Management Role:
No management responsibility
Required Experience:
IC
Key Skills
- Bluebeam
- Construction Estimating
- Construction Experience
- ProCore
- Microsoft Outlook
- Prolog
- Construction Management
- Project Engineering
- Project Management
- Project Management Software
- Microsoft Project
- Budgeting
About Company
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