4 Clinical Trial Manager Jobs in Carmel, IN
MBX Biosciences, Inc. is Hiring a Clinical Trial Manager Near Carmel, IN
- Use project management skills, processes, and tools to develop and execute global clinical trials.
- Understand the scope of work required to complete the clinical trial successfully. Monitor the status and make changes as needed to meet the deliverables of the trial.
- Develop and track global trial enrolment plan by gaining alignment and integrating inputs across functions and geographies.
- Assess, identify, and monitor trial-level risks and contingency plans.
- Understand cross-functional and trial-level budget components. Create and monitor the overall budget and assumptions using financial tracking tools. Routinely network with appropriate business partners, on trial-level budget status and changes.
- Partner with other organizations to coordinate and actively participate in Investigator Specific Training.
- Drive and coordinate cross-functional study team throughout study implementation, execution and closure empowering them to meet the clinical trial deliverables, including issue management, contingency planning, and issue resolution.
- Be accountable for trial enrolment strategy and execution starting from country allocation through Last Patient Entered Treatment (LPET)
- Manage relationships and serve as a single point of contact and central owner for trial communication to Third Party Organization (TPOs).
- Apply problem-solving skills to daily issues with cross-functional study team.
- Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, new technology, etc.
- Provide input into the development of bid proposals, manage TPO qualification process, selection, and oversight.
- Demonstrate understanding of drug development process.
- Single point of accountability for the Trial Master File for clinical, working closely with TPO to ensure the file is current and inspection ready at all times.
- Network and leverage expertise to anticipate trial issues, identify areas of process breakdown, assess situations, and propose proactive approaches that reduce and/or mitigate risks that impact ability to deliver the clinical trial.
- Demonstrate ability to lead and influence amid ambiguity.
- Coach peers, cross-functional team members and TPOs on aspects of clinical trial process.
- Report, manage and interpret information for the clinical trial(s).
- Apply expertise and knowledge of Good Clinical Practice (GCP) and MBX standards of operation in the conduct of clinical trials.
- Provide input into MBX clinical SOPs.
- Leverage scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents, prepare for meetings with regulatory agencies and draft responses to questions from regulatory agencies and TPOs.
- Combine scientific and operational knowledge as well as process expertise to impact clinical trial design, feasibility, and implementation.
- Utilize clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business.
- Bachelors in life sciences or health-related field
- 8 years clinical research experience or relevant experience in a scientific or health-related field.
- Applied knowledge of project management methodology, processes, and tools
- Demonstrated ability to work cross-culturally and with TPOs
- Ability to influence without authority
- Strong leadership and networking skills exhibited while working in cross-functional and cross-cultural teams (internal & external) and on projects
- Effective and influential communication, self-management, and organizational skills
- Demonstrated ability to manage complex situations through problem-solving, critical thinking and navigating ambiguity
- Flexibility to adjust to altered priorities
- Clinical development experience preferred
- Ability to influence and oversee TPOs to enable delivery of trial level deliverables.
- Minimum of 8-10 years clinical trial experience with a strong working knowledge of the clinical research process
- Proficiency in use of project management tools and techniques (MS Project, MS Excel, MS PowerPoint)
- Ability to travel (up to 10%)
Job Summary
Full Time
$89k-116k (estimate)
01/19/2024
06/11/2024
mbxbio.com
Carmel, IN
<25
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The job skills required for Clinical Trial Manager include Clinical Trial, Clinical Research, Leadership, Problem Solving, Project Management, Accountability, 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.
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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.
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Clinical trial managers also hire, train, and evaluate the members of the clinical team.
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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.
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A clinical trial manager must also possess effective leadership abilities.
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Clinical Trial Managers must possess excellent communication skills, leadership ability and multitasking personality.
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Step 3: View the best colleges and universities for Clinical Trial Manager.
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