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Clinical trial manager skills for your resume and career

15 clinical trial manager skills for your resume and career
1. Patients
- Conducted medication reconciliation, established goals of therapy and communicated effectively with several patients suffering from chronic pain and substance abuse.
- Coordinated patients and key opinion leaders participating in Focus Groups and one-on-one interviews.
2. Clinical Trial Management
- Provided instruction to internal and external (vendor) team members regarding the fundamentals of clinical trial management and regulatory requirements.
- Utilize clinical trial management system to manage protocol opportunities.
3. Clinical Operations
Clinical operations caters to the administration of the drug development process by ensuring there is proper planning, appropriate conduct through the process, safety of patients and use of quality data. It also encompasses facilitating effective communication between the different study sites and sponsors of the drug process.
- Asked to transfer to Clinical Monitoring Manager position to assist in development of Clinical Operations
- Maintained internal Clinical Operations, Medical Affairs databases and clinical study document repositories.
4. Clinical Research
- Fostered positive and productive professional relationships between our 22 sites, numerous principal and sub-investigators, and clinical research coordinators.
- Led design and implementation of integrated project management function to globalize product development and clinical research activities.
5. Oversight
Having oversight of someone means to monitor a process or a situation. If someone has oversight of something, they are responsible for the completion of the project. Oversight is usually given to experts as they monitor their juniors or newbies as they go through a project.
- Managed compliance oversight for regulatory issues per protocol requirements, applicable regulatory requirements.
- Presented overall audit to clinical policy and oversight committee and departmental managers.
6. Project Management
- Managed clinical study set-up and follow- up study activities through ongoing progress to appropriate clinical management and project management forums.
- Interact with Clinical Trials Data Management and Project Management teams to assess feasibility of automation of manual processes.
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- Ensured that assigned studies were conducted following the protocol, ICH, GCP, and all applicable global regulatory requirements.
- Ensured that program activities are conducted following the protocol, ICH, GCP and all applicable global regulatory requirements.
8. GCP
Google Cloud Platform (GCP) is a collection of cloud computing services that allow users to develop, deploy, and operate original applications on the web. GCP carries a cloud computing infrastructure that facilitates it in keeping track of the resources (e.g., storage, processing speed, and power, network connectivity, database queries, etc.) of an application or a website, whenever it is run on the cloud platform.
- Train and Mentor investigative sites on GCP guidelines, protocols and electronic data capture modules for the Remote Data Management System.
- Identify and recruit potential Investigator sites which include site visits throughout the trial to ensure compliance with trial and GCP guidelines.
9. CRO
A CRO (Cathode Ray Oscilloscope) refers to an electrical device usually used in a laboratory to exhibit, measure, and analyze different waveforms of electrical circuits.
CRO may also refer to Conversion Rate Optimization -- the practice of improving a process or product to maximize the number of conversions or sales.
- Provide support for Registration/Submission of CMC dossiers in collaboration with Regulatory, Clinical team and CRO
- Developed and initiated formal risk management plans and mitigation plans in collaboration with participation CRO.
10. Oncology
Oncology is defined as the facet of medicine that deals with cancer. Oncology also deals with the prevention and diagnosis of these diseases. A medical professional who has studied the discipline of oncology is referred to as an ‘oncologist'. An oncologist can further specialize in their discipline and become a medical oncologist, surgical oncologist, or radiation oncologist.
- Facilitated Scientific Discussion: Assisted in starting a statewide thoracic oncology journal club including contacting thought leaders personally and designing communications.
- Led study data management activities for oncology trials in preparation for study close-out.
11. Informed Consent
- Performed clinical coordinator duties including informed consent, study procedures, data management and monitoring visits.
- Reviewed changes to local informed consent forms and responded to regulatory-related inquiries from sites
12. Data Entry
Data entry means entering data into a company's system with the help of a keyboard. A person responsible for entering data may also be asked to verify the authenticity of the data being entered. A person doing data entry must pay great attention to tiny details.
- Perform data entry, organizing, inventory with pharmaceutical quality systems.
- Handled submissions: IND submissions to FDA, SAE drafting and submissions to sponsor, and data entry accuracy.
13. 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.
- Performed interim monitoring visits in preparation for FDA inspections and NDA applications.
- Participated in FDA audit preparation and audit completion.
14. Clinical Sites
- Manage development of study documents and overall direction of clinical sites.
- Recognized by clinical site, Stanford Medicine Fertility and Reproductive Health, for operating and completing an outstanding Phase I study.
15. Issue Resolution
Issue resolution refers to a set of processes that can be used to resolve an issue, conflict, dispute, or claim, and the ability to deal with the problems that need to be resolved, the decisions that need to be made, and the risks that need to be mitigated. Essentially, an issue resolution process intends to make it easier for people to come to a resolution following an issue.
- Manage clinical study material; implement issue resolution plans.
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What skills help Clinical Trial Managers find jobs?
Tell us what job you are looking for, we’ll show you what skills employers want.
What technical skills for a clinical trial manager stand out to employers?
Sharolyn Kawakami-Schulz Ph.D.
Director, Office of Professional Development, University of Minnesota Medical School
What soft skills should all clinical trial managers possess?
Research Professor Financial Engineering, Director Hanlon Laboratories, Director Financial Analytics program, Stevens Institute of Technology
List of clinical trial manager skills to add to your resume

The most important skills for a clinical trial manager resume and required skills for a clinical trial manager to have include:
- Patients
- Clinical Trial Management
- Clinical Operations
- Clinical Research
- Oversight
- Project Management
- Ich
- GCP
- CRO
- Oncology
- Informed Consent
- Data Entry
- FDA
- Clinical Sites
- Issue Resolution
- Consent Forms
- Data Collection
- Data Management
- CTM
- EDC
- Electronic Data
- TMF
- Trip Reports
- IRB
- Site Monitoring
- Pharmaceutical Industry
- CRAs
- Operational Aspects
- Patient Recruitment
- Study Start-Up
- QC
- IVRS
- Study Timelines
- Clinical Study Reports
- Study Sites
- Study Protocols
- Quality Standards
- IV
- Vendor Management
- Site Selection
- CRF
- IND
- Regulatory Submissions
- Study Budget
- Site Initiation
- Principal Investigators
- Direct Reports
- Federal Regulations
Updated January 8, 2025