1+ months

Clinical Study Manager

Kelly Services
Cincinnati, OH 45217
**Direct Hire * Permanent * Fulltime * Hybrid* Up to 25% travel**

**Job Title:**

Clinical Trial Manager

Cincinnati, OH

**Supervisory Responsibility:**

Clinical Trial Operations support staff including, but not limited to, Administrative Coordinators or other CTMs.

Kelly Science & Clinical is searching for an Associate Director of Clinical Trial Operations. Our client is an Clinical Research Organization (CRO) dedicated to promoting good quality of care in wound healing, lower extremity, plastics and orthopedics through the pursuit of quality clinical research and trial management.

**Education Required:**

+ Must have a bachelors degree preferably in business management, biology, health sciences, healthcare or any related field.

+ Advanced degree preferred.

**Experience Required:**

+ Minimum of 4 years of clinical research experience

+ Minimum of 1 years of trial management experience

+ Must have exceptional leadership, technical and communication skills at both the site and Sponsor level. CRO experience is a plus

+ Ability to multitask and maintain excellent organizational skills.

**Duties and Responsibilities:**

+ Manage day-to-day operations of the study from start-up to database lockout according to ICH/GCP, SOPs, and all other applicable laws, rules and regulations

+ Serve as primary Sponsor and Vendor contact for operational project-specific issues and study deliverables

+ Provide oversight for project team and third-party vendors, ensuring all cross-functional deliverables are met

+ Maintain in depth knowledge of protocol, therapeutic area and indication

+ Review and provide input for studies including, but not limited to, protocol writing, inform consent form, edit check specifications, contracts and budgets, regulatory submission strategies, and final study report

+ Develop study management tools, including operational study plans and project timelines

+ Act as initial resource for study CRAs and sites with any protocol related questions

+ Provide oversight to ensure timely reporting and processing of AEs and SAEs to the Sponsor

+ Facilitate CTA negotiation and approve site payments and work closely with the Controller

+ Provide direct supervision of PERI Administrative Coordinators

+ Appropriately communicate site feedback and correspondence as applicable to the Senior Director of Clinical Trial Operations or the PERI Executive Committee and the Sponsor.

+ Assist with monitoring data for completeness and accuracy (via centralized or remote monitoring), on-site monitoring, and completing monitoring reports and letters for post market clinical trials.

+ Provide trial updates in a timely manner to the Sponsor and other designated individuals following appropriate templates, including managing team teleconference, as required.

+ Review CRA monitoring reports for completion and accuracy


**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** **** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.


Posted: 2022-08-19 Expires: 2022-10-20

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Clinical Study Manager

Kelly Services
Cincinnati, OH 45217

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