Clinical Study Manager

Kelly Science & Clinical is seeking a Clinical Study Manager. Please send your resume to Alicia Cali at or call/text at

Job Description:

The Clinical Study Manager is responsible for the execution of high quality clinical studies and will focus on study management activities to meet study objectives.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

+ Supervises and provides input to the development and management of study related documents including clinical protocols, case report forms, monitoring plans, study manuals, and other study- related tools

+ Assists in the development of the study budget and updates as needed throughout the study including oversight to ensure spending remains within budget guidelines

+ Oversees training of CRAs and ensures all study personnel are trained on the protocol

+ Oversees and participates in clinical site qualification, activation and initiation processes, including review and approval of site activation documentation

+ Participates in negotiation of agreements with clinical sites

+ Supervises and provides input into the planning of, preparing materials for, and presenting at investigator and coordinator meetings

+ Oversees and participates in the study protocol training for investigators, research coordinators, and other study personnel

+ Provides ongoing updates regarding the progress of clinical studies, e.g., subject screening and enrollment, data collection, and adverse event management

+ Ensures adequate monitoring is conducted and may conduct monitoring visits at investigational sites as needed

+ Evaluates clinical data and provides oversight for data management, query generation and resolution and reporting of adverse events

+ Assists with development and implementation of site corrective actions as needed to address any compliance issues

+ Oversees completion of clinical reports, study summary reports, and provides input for abstracts/manuscripts/presentations in conjunction with the clinical team and investigators

+ Manages Core laboratories and contract research organizations (CROs) involved in the study

+ Contributes to ongoing Standard Operating Procedure (SOP) development and review

+ Responsible for ensuring study is audit-ready at all times

+ Conducts regular meetings with the study team

+ Coordinates, participates in the preparation for, and attends, CEC and DSMB meetings

+ Provides support for regulatory submissions and preparation for meetings with regulatory agencies

+ May participate as a member of a Project Team representing Clinical Affairs, as assigned

+ Supervises direct reports including interviewing and hiring, ensuring training, work assignments, evaluating their performance on an ongoing basis and providing feedback on day-to-day performance, and conducting annual performance reviews

**Education:**

??? Bachelor's degree in health sciences or related field

**Experience:**

??? 3-5 years of clinical research experience, including 1-3 years of experience managing projects

??? Experience in cardiovascular/heart valve disease is highly desired

??? Experience with medical device clinical studies Skills:

??? Advanced communication skills, both orally and in writing, with excellent interpersonal and diplomacy skills

??? Proficient computer skills (Microsoft Word, Excel, PowerPoint, etc.)

??? Good organizational and problem-solving skills

??? High attention to detail and degree of accuracy

??? Works independently and in a team environment

??? Experience coordinating, prioritizing, setting timelines, and multi-tasking

??? Knowledge and understanding of medical terminology

??? Expertise with medical device regulations and compliance guidelines for clinical studies

??? Expertise with Good Clinical Practice (GCP)

??? Professional demeanor and appearance

**Other:**

??? Position requires approximately 30% travel; additional travel may be needed during periods of the study such as site activation

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **??** **?**

Kelly?? Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** **??**

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. ()