Job Information
Kelly Services Clinical Trial Manager in Stafford, Texas
Clinical Trial Manager
Opportunity : Direct Hire/Full Time
Schedule : Monday – Friday, 8:00 AM – 5:00 PM?
Reports to : Associate Director, Team Lead Site Operations
Location : Fully Remote
Salary : $120k – 140k annually
Travel : Up to 25% as needed
Kelly Science and Clinical is hiring a Clinical Trial Manager for one of our clinical-stage biopharmaceutical clients who is dedicated to advancing immunotherapy innovations. We are seeking a Clinical Trial Manager to support their U.S. Clinical Operations team. The CTM will oversee site management and monitoring activities in compliance with GCP, applicable regulations, and SOPs.
As a Clinical Trial Manager, you will play a key role in supporting our financial operations: ?
Collaborate with COL (Clinical Operations Lead) to set targets for clinical monitoring activities, and ensure the recording of the trial in compliance with project goals
Conduct and oversee the clinical trial site feasibility and site selection process
Create, maintain and implement trial-specific plans, tools and documents required per SOP (Standard Operating Procedure) (e.g., training material, annotated trip reports, Clinical Monitoring Plan, Deviation Handling Plan)
Oversee or perform collection of clinical trial site specific documents ensuring on time regulatory submissions (CA, IRB/IEC) according to local requirements
Driving the clinical site initiation and greenlight process according to project goals
Actively contribute to clinical trial site management and engagement to establish and maintain close site relationships
Organize and oversee project-specific training for CRAs (Clinical Research Associate) and clinical trial sites
Review trip reports and provide day-to-day expert advice to CRAs
Review progress of clinical trials, especially patient recruitment and clinical trial data capture, and initiate appropriate actions to achieve objectives
Conduct Monitoring Oversight Visits?ensuring clinical trial site and internal/external CRA (Clinical Research Associate) performance
Manage protocol and GCP deviations as Deviation Manager according to SOP
Secondary Functions :
- Proactively contributes to continuous improvement of Clinical Operation specific processes, procedures and templates
Required Experience and Education :
Min. bachelor's degree, preferably in life science or nursing, or equivalent
At least 2 years of on-site monitoring required from past experience
At least 2 years of Clinical Trial Manager experience in the pharmaceutical or biotechnology industry (including all clinical monitoring visit types)
Comprehensive knowledge of ICH-GCP, FDA (Food and Drug Administration) and EMA (European Medicines Agency) (European Medicines Agency) and applicable local regulations and laws
Understanding of basic medical oncology terminology and science preferable
Demonstrated computer skills, including Microsoft Office and clinical trial systems (i.e., eTMF, CTMS)
Advanced understanding of priorities within own scope with limited interaction with the supervisor
Proactively driving quality and efficiency to meet timelines and milestones in own scope
Advanced presentation and organizational skills
Legal eligibility to work in the United States is required
Preferred Experience and Education: ?
Proactively driving company standards, global harmonization and innovation in own scope
Advanced reflection on complex process structures and connections
Fostering innovation and development in own area of expertise
*Competencies: *
Advanced team leader skills and dedicated team player
Proactive attitude with powerful sense of responsibility within own scope
Positive attitude and willingness to learn and contribute to a team
Proficient time management to work efficiently and economically
Analytical reasoning and advanced project management skills
Strong ability to identify, deeply analyze and communicate problems
Proficient verbal and written communication skills in English with high degree of tact and diplomacy
?
Comprehensive Benefits :? Our client believes in investing in their team’s health, safety and well-being. Competitive rates for Health, Dental, and Vision Insurance
4 weeks of Paid Time off, granted up front each year and prorated for first and last year of employment.
Sick Time Off – 56 hours
12 Paid Holidays
100% Employer-Paid Life Insurance?up to at 1x annual salary
100% Employer Paid Short- and Long-Term Disability Coverage?
401(k) with Immediate Eligibility? & company match…
You are eligible for 401(k) plan participation as of your first paycheck.
The company will match 100% of your contributions, up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment.
Partially paid Parental Leave?for eligible employees. (3 weeks)
Additional voluntary employee paid coverages including Accident, Hospital Indemnity, and Critical Illness?Employee Paid Identity Theft Protection and Pet Insurance.
Professional Growth :?
Opportunities to work with leading experts in the field of T-cell immunotherapy.?
Company provides learning and development opportunities.
Fast paced, high demand collaborative and dynamic environment.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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 world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s 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
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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 Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.