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Senior site manager skills for your resume and career
15 senior site manager skills for your resume and career
1. Informed Consent
- Assisted with the development of monitoring plans, informed consents, site training documents, and source document templates.
- Assist with protocol and CRF review; Develop informed consent forms.
2. Clinical Trial Management
- Budget negotiation, contract execution and clinical trial management.
- Provide clinical trial management and support in accordance with FDA guidelines, ICH/GCP, and local working instructions.
3. Clinical Trials
- Managed all aspects of clinical trials including assisting upper management with new initiatives aimed at improving team performance.
- Serve as a Regional Site Manager on six protocols with 35 individual investigative sites that conduct clinical trials.
4. FDA
The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.
- Developed/implemented regulatory compliance training program in anticipation of FDA PMA submission audits.
- Prepare investigative sites for Sponsor and FDA audits; maintain inspection readiness for all assigned study sites.
5. IRB
An institutional review board (IRB), is a form of committee that applies research ethics by vetting research procedures to ensure they are ethical. In order to decide whether or not research can be undertaken, they often perform a kind of risk-benefit analysis. The IRB's function is to ensure that adequate safeguards are in place to protect the interests and health of humans who are participants of a research sample.
- Capture and report of Adverse Event and Serious Adverse Event (Including to IRB).
- Submit study updates to Sponsor and IRB as needed.
6. QA
QA, or Quality Assurance is a procedure that entails all of the steps taken to avoid any errors in the manufacturing process or in the production of the goods that a company produces. It can also include ensuring the consistency of the services rendered. Quality assurance ensures that the quality of the service delivered to consumers meets or exceeds the promised expectations. This greatly aids in the prevention of any complications that might arise after the goods or services have been distributed. It makes sure that customers are satisfied.
- Managed non-compliance material returns, QA reports and receiving reports resolving any issues quickly and efficiently.
- Worked extensively with the Owners QA staff and the on site NRC staff.
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- Identified eligibility for social service programs and referred patients to the appropriate social service agencies.
- Managed case load of 6-8 patients for last quarter of clinical.
8. Project Management
- Provided project management to coordinate delivery, removal, and installation of equipment along with provided weekly status updates and reports.
- Project management at the country-level from site activation through site-closure.
9. Site Monitoring
- Completed site monitoring trip reports.
10. Process Improvement
- Develop opportunities within account and maintain process improvement and service levels.
- Focused Operations Manager successful in negotiation and process improvements.
11. Routine Monitoring
- Conducted evaluation, initiation, and routine monitoring and close out visits.
- monitor - performing pre-study assessments, routine monitoring visits, initiation visits and study close-out.
12. Direct Reports
- Hold weekly meetings in which direct training, coaching and performance expectations are given to direct reports.
- Attended two management classes per year and handled all Human Resource issues for direct reports.
13. Safety Reports
- Follow up of drug safety issues and safety reports in timely manner, if applicable.
- Follow up of drug safety issues and safety reports.
14. Lean Six Sigma
- Prioritized projects, trained personnel, and lead teams to successfully implement lean six sigma principles that significantly improved operating performance.
- Lean Six Sigma Awareness training.
15. OSHA
- Developed and implemented the site EH&S and emergency response plan in accordance with OSHA and EPA requirements.
- Participated in the OSHA's VPP program and was instrumental in helping the client gain star status.
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Jaunelle Celaire
Chair, Professor of Voice, University of Alaska Fairbanks
List of senior site manager skills to add to your resume

The most important skills for a senior site manager resume and required skills for a senior site manager to have include:
- Informed Consent
- Clinical Trial Management
- Clinical Trials
- FDA
- IRB
- QA
- Patients
- Project Management
- Site Monitoring
- Process Improvement
- Routine Monitoring
- Direct Reports
- Safety Reports
- Lean Six Sigma
- OSHA
- Ich
- GCP
- Corrective Action
- Customer Satisfaction
- Sigma
- B Testing
- Study Procedures
- Performance Reviews
- Employee Development
- Financial Reimbursement
- Payroll
- DOD
- Clinical Data
- Site Management
- CRF
- Cost Savings
- Clinical Operations
- Inventory Control
- Human Resources
- CRAs
- Expense Reports
- Study Drug
- Site Training
- Principal Liaison
- Site Selection
- Windows
- Query Process
- KPI
- Business Development
- PC
- MRO
- DTI
Updated January 8, 2025