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Clinical study manager skills for your resume and career

Updated January 8, 2025
6 min read
Quoted expert
Sharolyn Kawakami-Schulz Ph.D.
Below we've compiled a list of the most critical clinical study manager skills. We ranked the top skills for clinical study managers based on the percentage of resumes they appeared on. For example, 7.2% of clinical study manager resumes contained gcp as a skill. Continue reading to find out what skills a clinical study manager needs to be successful in the workplace.

15 clinical study manager skills for your resume and career

1. 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.

Here's how clinical study managers use gcp:
  • Planed, tracked, and conduct follow-up on all site GCP audits, and vendor audits as required.
  • Frequent presenter at company's GCP workshop and Investigator Meetings, end of study meetings.

2. Informed Consent

Here's how clinical study managers use informed consent:
  • Negotiated and edited informed consent documents directly with the investigator site staff at multiple US oncology centers.
  • Leveraged study management knowledge to advise on protocol design and prepare necessary informed consent documents.

3. 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.

Here's how clinical study managers use oversight:
  • Delivered oversight of patient recruitment and retention efforts of country offices.
  • Perform Co-Monitoring Quality Oversight visits as necessary per Quality Oversight Plan.

4. 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.

Here's how clinical study managers use clinical operations:
  • Led study conduct and study monitoring team in clinical operations activities.
  • Served on clinical operations task forces or department initiatives.

5. ICH

Here's how clinical study managers use ich:
  • Adhered to and complied with internal SOP's, ICH Guidelines and Good Clinical Practice.
  • Created document templates required by FDA and ICH regulations for site distribution.

6. Data Management

The administrative process that involves collecting and keeping the data safely and cost-effectively is called data management. Data management is a growing field as companies rely on it to store their intangible assets securely to create value. Efficient data management helps a company use the data to make better business decisions.

Here's how clinical study managers use data management:
  • Performed data management and clinical review of patient data and address discrepancies using Integrated Review and Oracle Clinical databases.
  • Review and provide feedback to functional SMT members on Monitoring Plan/Data Management Plan/Statistical Analysis Plan.

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7. Patients

Here's how clinical study managers use patients:
  • Contacted patients regarding study information.
  • Assisted patients who suffer from depression, bipolar mood disorders, mental retardation, schizophrenia, post-traumatic disorder.

8. Data Collection

Data collection means to analyze and collect all the necessary information. It helps in carrying out research and in storing important and necessary information. The most important goal of data collection is to gather the information that is rich and accurate for statistical analysis.

Here's how clinical study managers use data collection:
  • Worked with programmers and system developers to create data collection applications and develop data transfer procedures.
  • Create data collection instruments/tools and corresponding databases.

9. 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.

Here's how clinical study managers use fda:
  • Managed projects related to commercialization and post market analysis for abdominal aortic aneurysm repair grafts as guided by FDA regulations.
  • Managed staff of scientists and assistants preparing and executing cosmetic clinical trials according to FDA and Good Clinical Practice regulations.

10. Study Management

Here's how clinical study managers use study management:
  • Coordinated study efforts between European Heart Valves Study Management Group and Heart Valves' Clinical Study Group.
  • Assisted with the development and implementation of study management tools and tracking databases.

11. 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.

Here's how clinical study managers use cro:
  • Recommended and successfully transitioned a study from a CRO back in-house for significant operational cost savings.
  • Performed evaluations of CRO performance via co-monitoring visits, and documented in co-monitoring visit reports.

12. Clinical Trial Management

Here's how clinical study managers use clinical trial management:
  • Provided training and education to internal and external team members regarding the expectations for clinical trial management and regulatory compliance needs.
  • Maintained clinical trial management systems effectively in order to ensure adequate communication to project team and sponsor.

13. Study Start-Up

A study-start up serves as the foundation of every clinical study, and it helps determine the success of every project. The study start-up is also the stage where the clinical data manager negotiates with sponsors and other business partners, developing comprehensive plans for the study.

Here's how clinical study managers use study start-up:
  • Coordinated all study start-up and closeout activities within a matrix environment with other departmental team members.
  • Create study start-up files, track and obtain outstanding regulatory documents from sites.

14. TMF

Certain documents, images, and content are required to fulfill the government's requirements on any matter. You can satisfy these regulatory requirements by providing information known as the Trial Master Files. The TMF consists of trial sponsors and participating investigators set of contents that permit the clinical trial to be conducted and attest the trial's collected data.

Here's how clinical study managers use tmf:
  • Created and implement an in-house TMF with recommendations from CQA vendor.
  • Assure proper study documentation is maintained and archived in the TMF.

15. Consent Forms

Consent forms refer to something that a person signs or attests to in order to agree for something that involves them to happen. They are used in various fields and applications. It is a legal document that can have repercussions if forged or denied later. In medical terms, it is the informed consent of the patient agreeing to the medical procedure they are about to undergo in a sound state of mind.

Here's how clinical study managers use consent forms:
  • Develop consent forms and study outlines.
  • study level consent forms, advertising materials), and study deviation specifications.
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What skills help Clinical Study Managers find jobs?

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What technical skills for a clinical study manager stand out to employers?

Sharolyn Kawakami-Schulz Ph.D.Sharolyn Kawakami-Schulz Ph.D. LinkedIn profile

Director, Office of Professional Development, University of Minnesota Medical School

Graduates who possess certain technical skills should be sure to demonstrate in their job documents how those skills meet the needs of an employer. However, more than any particular technical skill, graduates will need to demonstrate their ability to continue to learn and adapt. Communication skills - written, oral, and to various audiences - will continue to be key in their ability to succeed and do well in all sectors.
Do you want to know more?
Read more about what experts have to say about clinical study manager

List of clinical study manager skills to add to your resume

Clinical study manager skills

The most important skills for a clinical study manager resume and required skills for a clinical study manager to have include:

  • GCP
  • Informed Consent
  • Oversight
  • Clinical Operations
  • ICH
  • Data Management
  • Patients
  • Data Collection
  • FDA
  • Study Management
  • CRO
  • Clinical Trial Management
  • Study Start-Up
  • TMF
  • Consent Forms
  • Clinical Practice
  • Study Design
  • Operational Aspects
  • Pharmaceutical Industry
  • Data Entry
  • Study Sites
  • IRB
  • Study Plans
  • EDC
  • Regulatory Submissions
  • Study Timelines
  • Investigational Product
  • CRF
  • Study Budget
  • QC
  • Clinical Study Reports
  • Clinical Sites
  • QA
  • Site Selection
  • Patient Recruitment
  • Vendor Selection
  • Site Monitoring
  • Direct Reports
  • External Vendors
  • Business Development
  • Clinical Trial Material
  • IND
  • IVRS
  • Query Resolution
  • Database Lock
  • Study Activities
  • Regulatory Compliance
  • ICF
  • GLP

Updated January 8, 2025

Zippia Research Team
Zippia Team

Editorial Staff

The Zippia Research Team has spent countless hours reviewing resumes, job postings, and government data to determine what goes into getting a job in each phase of life. Professional writers and data scientists comprise the Zippia Research Team.

Updated January 8, 2025

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