10 Clinical Trial Manager Jobs in Burlington, MA
Fractyl Health, Inc is Hiring a Clinical Trial Manager Near Burlington, MA
Primary Responsibilities
- Manage the CRA team’s deliverables
- Mentor CRAs to understand the role and responsibilities as well as the study protocol
- Oversee proper study monitoring requirements, inclusive of adherence to monitoring SOPs, monitoring plans, GCP guidelines, regional regulations, and quality and risk-based effectiveness
- Working with the CRA team, manage site trends and metrics through dashboard review and ongoing risk assessments to ensure quality standards
- Guide in the development of important study documents
- Lead and implement improvements to optimize effectiveness and efficiencies within the team
- Oversee and ensure successful relationships with clinical sites, addressing issues escalated by study teams
- Oversee and coordinate adequate site monitoring allocations, training, visit schedules and reports
- Develop and implement CRA training plan, tracking training metrics and reports
- Attend and/or support co-monitoring visits as needed, evaluating the CRAs deliverables and ensuring success
- Attend and/or support Investigator/Site identification and meetings as needed
- Design, develop and provide monitoring plans, reports, processes and playbooks
- Develop SEV, SIV and other site trainings and presentations
- Support site audits/inspections as needed, and follow through with findings to resolution
- Working with Oversight Monitor, develop tools and processes for conduct of Quality Evaluation visits
- Perform all activities in compliance with applicable regulations, Fractyl’s policies and guidelines, including, but not limited to, timely documentation of activities and maintaining all required applicable training
- Bring a “can do” spirit to work and deliver on other responsibilities as assigned
- Bachelors or Masters degree in any Science related field
- Requires greater than 4 years clinical research experience including project management experience or equivalent combination of education, training and experience
- Thorough understanding of clinical study process and execution with extensive knowledge of ICH-GCP
- Strong knowledge of clinical trial regulations (US FDA, EMEA, etc.)
- Hands-on experience in managing and mentoring teams
- Experience in biotech, pharmaceutical and/or medical device industries preferred.
- Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.).
- Highly effective interpersonal skills
- Solid problem solving and analytical skills
- Ability to handle large and complex trials
- Working knowledge of clinical study conduct inclusive of successful track record of timely cross-functional communication
- Successful track record of working in high-growth and dynamic organizations
- Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
- Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
- Evidence of "hands-on" experience and expertise
- Proven and successful track record as a team-player and collaborator in small working environments
- Highly organized and detail oriented with a passion to deliver quality results
- Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation
- Highest levels of professionalism, confidence, personal values and ethical standards
- This position requires up to 30% travel, when needed.
Job Summary
Full Time
$109k-142k (estimate)
06/27/2024
07/25/2024
The job skills required for Clinical Trial Manager include Clinical Trial, Clinical Research, Clinical Operations, Clinical Monitoring, Problem Solving, Written Communication, etc. Having related job skills and expertise will give you an advantage when applying to be a Clinical Trial Manager. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Clinical Trial Manager. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Clinical Trial Manager positions, which can be used as a reference in future career path planning. As a Clinical Trial Manager, it can be promoted into senior positions as a Clinical Research Director that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Clinical Trial Manager. You can explore the career advancement for a Clinical Trial Manager below and select your interested title to get hiring information.
If you are interested in becoming a Clinical Trial Manager, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Clinical Trial Manager for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on Clinical Trial Manager job description and responsibilities
Presented overall audit to clinical policy and oversight committee and departmental managers.
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Before a medical treatment can be administered to the general population, a clinical trial manager needs to oversee a test study.
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Clinical trial managers make sure all aspects of clinical trials meet regulatory requirements and scientific standards while protecting patient safety.
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Clinical Trial Managers are responsible for executing and supervising clinical trials using effective organizational strategies.
03/24/2022: Alamogordo, NM
Learn more about the requirements, responsibilities, training, salary, and job outlook of Virtual Clinical Trial Managers.
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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Clinical Trial Manager jobs
Communication, feedback, and mentoring are part of a clinical trial manager's job.
02/21/2022: Riverside, CA
Clinical trial managers also hire, train, and evaluate the members of the clinical team.
01/23/2022: Flagstaff, AZ
Without a Clinical Trial Manager to select projects and balance speed with safety, Physicians would waste time researching low-demand medications while putting lifesaving medicines on hold.
04/05/2022: Battle Creek, MI
A clinical trial manager must also possess effective leadership abilities.
03/24/2022: Bangor, ME
Clinical Trial Managers must possess excellent communication skills, leadership ability and multitasking personality.
04/01/2022: Springfield, MA
Step 3: View the best colleges and universities for Clinical Trial Manager.
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