Study Manager
Durham, NC
Full Time
IVT
Experienced
General Information
Position Summary
A Study Manager has the responsibility to supervise and coordinate activities of client projects; identify areas
of improvements and develop new processes; lead and manage the execution of assigned studies.
Essential Functions
The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is occasionally required to walk; sit; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Limitations and Disclaimer
The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws. Requirements are representative of minimum levels of knowledge, skills, and/or abilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.
| Title: Study Manager | Date: 5May2025 |
| Business Unit: XXX | Department: In Vitro Testing |
Position Summary
A Study Manager has the responsibility to supervise and coordinate activities of client projects; identify areas
of improvements and develop new processes; lead and manage the execution of assigned studies.
Essential Functions
- Provide strategic and technical oversight on studies.
- Collaborates on continuous process improvement opportunities.
- To draft study plans and contribute to the preparation of reports for sponsors.
- For any studies performed according to GLP, act as Study Director to assure that:
- The study protocol (plan), including any change, is approved and is followed.
- All experimental data including observations of unanticipated responses of the test system are accurately recorded and verified.
- Unforeseen circumstances that may affect the quality and integrity of the study are noted when they occur, and corrective action is taken and documented.
- Test systems are as specified in the study protocol (plan).
- GLP regulations are followed where appropriate.
- All raw data, documentation, protocols, specimens and final reports are transferred to the archives during or at the close of the study.
- To adhere to MedPharm’s Procedures.
- Contribute to the preparation and review of SOPs and Forms where applicable.
- Where applicable, promptly record all data according to Good Documentation Practices.
- Review literature in preparation for studies and to regularly update knowledge by reviewing appropriate literature.
- Supervisory Responsibilities - This position may be responsible for training, assisting or assigning tasks to others.
- Any other duties and/or tasks that may be assigned.
- Bachelor’s degree in relevant scientific field (e.g. Chemistry, Biology, etc.)
- 3-5 years of relevant experience
- Proficiency in technical writing
- Must be able to analyze data sets and interpret results
- Familiarity with JMP is a plus, but not required
- Proficiency with Microsoft Office (Word, Excel, PowerPoint, Teams, etc.) required.
- Up to 5%
The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is occasionally required to walk; sit; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Limitations and Disclaimer
The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws. Requirements are representative of minimum levels of knowledge, skills, and/or abilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.
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