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1+ months

Senior Clinical Study Manager

Kelly Services
Irvine, CA 92604
**Senior Clinical Study Manager**

**Medical Device; Interventional Cardiology**

**Irvine, CA**

**Long Term Contract (2-3 years)**

**Hybrid (3-4 days/week in office)**

**25% Travel**


Kelly Science & Clinical is searching for Senior Clinical Study Manager for a medical device company in Irvine, California.


As the **Clinical Study Manager** , you will be _responsible for planning and executing company sponsored global clinical trials._ It is a hands-on, high impact role with the opportunity to help transform how physicians manage patients with cardiovascular disease. If you have the entrepreneurial drive, demonstrated ability to collaborate with a variety of stakeholders in a fast-paced, start- up environment, this may be the role for you.


**Job Description** **:**


+ Plan, initiate and execute clinical studies with operational excellence

+ Plan and implement IRB submissions, site qualification, investigator qualification, site initiation, monitoring and close out activities in compliance with GCP and all applicable federal regulations.

+ Be accountable for effective management of budgets, timelines and resources for clinical studies and implementation of appropriate standards and processes to ensure clinical study quality

+ Be responsible for effective training and management of interactions with study team, study sites and vendors for clinical studies

+ Manage and lead the day-to-day operations of studies to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements

+ Provide accurate and up-to-date study information and provide regular updates of study progression

+ Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables

+ Implement appropriate systems, standards, and processes to ensure quality at the level of investigative sites, vendors and data

+ Lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team

+ Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans

+ Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members


**Required Qualifications/Skills:**


+ BA/BS degree with at least seven years clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 5 years clinical trial experience

+ Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.

+ Must have strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring.

+ Requires proven project management skills and study leadership ability.

+ Must have excellent interpersonal, written, and verbal communication skills, administrative skills and computer ability.

+ Fluent in English.

+ Up to 25% travel, sometimes over the weekend




\#P1


**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.

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

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Senior Clinical Study Manager

Kelly Services
Irvine, CA 92604

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