Plans, manages, and coordinates the execution of clinical study/studies according to regulatory requirements. Provides updates and ensures coordination between cross functional study team(s) to meet study objectives, on time and within budget. Provides guidance and mentors Program managers and handles additional sites. Job Responsibility Provides strategic advice and guidance to the Operations function. Guides and trains Program Managers in the performance of operational duties ; provides guidan... more details
Job Description
Plans, manages, and coordinates the execution of clinical study/studies according to regulatory requirements. Provides updates and ensures coordination between cross functional study team(s) to meet study objectives, on time and within budget. Provides guidance and mentors Program managers and handles additional sites.
Job Responsibility
Provides strategic advice and guidance to the Operations function. Guides and trains Program Managers in the performance of operational duties ; provides guidance to Program Managers to improve effectiveness and achieve operational goals.
Handles additional sites and acts as a resource for difficult or complex studies/ analysis ; gathers various metrics, analysis and reports findings to management within timeframes.
Designs, develops and modifies systems and procedures to enhance departmental processing.
Participates in cross functional study team(s) in protocol development, process development, data management amendments and administrative changes.
Participates in creation and maintenance of business development activities and standard operating procedures and provides support during audits.
Manages strategic partners, vendors, consultants for assigned studies.
Performs the evaluation and selection of vendors, including contract and budget negotiations.
Responsible for the day-to-day management of vendors, ensuring assignments, timeframes and budgets are met.
Assists with site identification and selection, enrollment models, clinical supply planning and drug supply, organization of investigator and vendor meetings, development of informed consents forms, planning and management of monitoring plans and Case Report forms and writing the Clinical Study Report.
Identifies study risks, develop risk mitigation plans, including communication and collaboration with program management, and escalates risks and study issues, with proposed solutions, to management as necessary.
Performs related duties as required. All responsibilities noted here are considered essential functions of the job under the Americans with Disabilities Act. Duties not mentioned here, but considered related are not essential functions.
Job Qualification
Bachelor's Degree required, or equivalent combination of education and related experience.
10+ years of relevant experience and 2+ years of leadership / management experience, required.
*Additional Salary Detail The salary range and/or hourly rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future.When determining a team member's base salary and/or rate, several factors may be considered as applicable (e.g., location, specialty, service line, years of relevant experience, education, credentials, negotiated contracts, budget and internal equity).
Job Abstracts is an independent Job Search Engine. Job Abstracts is not an agent or representative and is not endorsed, sponsored or affiliated with any employer. Job Abstracts uses proprietary technology to keep the availability and accuracy of its job listings and their details. All trademarks, service marks, logos, domain names, and job descriptions are the property of their respective holder. Job Abstracts does not have its members apply for a job on the jobabstracts.com website. Additionally, Job Abstracts may provide a list of third-party job listings that may not be affiliated with any employer. Please make sure you understand and agree to the website's Terms & Conditions and Privacy Policies you are applying on as they may differ from ours and are not in our control.
We would like to take a second to Welcome You to Job Abstracts, the nation’s largest Pure Job Board. With over 3.1 million job listings from 15,000+ Companies & Organizations, we help job searchers find careers that match their interests. As an anonymous user, you have probably discovered how easy our system is to use. However, you have just scratched the surface of what we can offer.
We encourage you to Register so you can use our most powerful features: searching with multiple terms, setting up multiple locations, establishing favorite companies, and accessing your search history. If you find a job you like, you can apply directly for it, and then, keep notes on it. We will also keep a lookout for jobs that match your search terms and email you when we find something you may like.
You can register for free and the system is free to use. If you like our system so far, click on Register and unlock the power required by serious job searchers.
Any time you conduct a search, the system shows you job matches, ranked by their Relevance Score (RS).
The score is calculated by a proprietary algorithm that uses Intelligent Machine Learning.
The Relevance Score tells you how well the job opportunity matches your search term or terms.
When not logged in, the system is limited to one search term. Scores for single term matches are usually lower.
When you register, log in, and set up multiple terms prioritized by importance, the jobs found for you will receive a much higher Relevance Score.
