Clinical Trial Manager Job Listing at Kelly Services in Stafford, TX (Job ID 10140889)

Description

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 Clinicalis hiring a Clinical Trial Manager for one of our clinical-stage biopharmaceutical clients who is dedicated to advancingimmunotherapy 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 Visitsensuring 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 Insuranceup 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 Leavefor eligible employees. (3 weeks) 

• Additional voluntary employee paid coverages including  Accident, Hospital Indemnity, and Critical IllnessEmployee 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 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

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly 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. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

 Apply on company website