Assistant Clinical Study Manager (Remote)

RTI International; Charlotte (NC); Remote; USD 77,000 - 94,000; Full time

Job summary

An established industry player is seeking an Assistant Clinical Study Manager to contribute to impactful clinical trials. In this role, you will work closely with a dynamic team to ensure the timely execution of high-quality studies, supporting drug development initiatives. You'll manage project components, coordinate communications, and assist in training clinical staff, all while adhering to best practices and regulatory standards. This position offers a unique opportunity to make a difference in global health, with a commitment to teamwork and innovation at its core. Join us in this rewarding journey to enhance the wellbeing of communities worldwide.

Benefits

Generous paid time off

Merit-based annual increases

Bonus opportunities

401(k) retirement savings plan

Paid parental leave

Financial assistance for education

Employee assistance program

Health insurance plans

Dental insurance plans

Life insurance

Qualifications

• 3+ years of experience in clinical trial operations.
• Strong knowledge of clinical trial drug development processes.

Responsibilities

• Assist in planning and execution of clinical trials.
• Manage project components under the Lead CSM's direction.

Skills

Clinical trial management

Project management

Data collection and management

Communication skills

Attention to detail

Education

Bachelor's Degree

Master's Degree

Tools

MS Word

MS Outlook

MS PowerPoint

MS Excel

Job description

Why RTI

RTI International (RTI) is both a global research institute and a leading international development organization based out of North Carolina. At RTI, you will find work you believe in, tackling some of the most complex global challenges of our time. Our mission is to impact the wellbeing of 1 billion people by 2030 through science-based solutions in climate, education, health, and equity. Our staff promote meaningful change around the world helping people live healthier, more productive, and more independent lives.

If you are looking for an opportunity to make a real difference, RTI is the place for you. Join us in our commitment to teamwork, belonging, and the passion to change the world.

About the Hiring Group

We are seeking an Assistant Clinical Study Manager (Asst. CSM) to join our team. The ideal candidate will be highly motivated, results-oriented, and collaborative with experience working as an integral member of a multi-site clinical trial operations team and on related drug development initiatives. The Asst. CSM will serve to support the Lead CSM (operational lead) for clinical trials, with tasks pertaining to study planning, budget and resource management, and oversight of project vendors and subcontractors, as applicable. Focused on operational excellence, this person will work closely with both the Lead CSM and Project Leadership to support management and coordination of a cross-functional study team to ensure the timely conduct of high-quality clinical trials in accordance with study protocols, Good Clinical Practice, Standard Operating Procedures, and applicable regulations.

Please note, this position manages the study, but does not have administrative management responsibilities for any staff.

What You'll Do

The key deliverables for this role are to assist and support in the planning and execution of complex clinical trials in accordance with designated timelines and budgets.

• Manage components of projects, under the direction of the Lead CSM.
• Assist in the preparation and oversee distribution of study documents and materials including data collection forms, manuals of operations and technical memos to research sites.
• Assemble and distribute various materials, including study supplies and data collection forms, to clinical sites.
• Coordinate and schedule conference calls; write and distribute meeting minutes.
• Manage correspondence and project communications.
• Assist in the preparation and updating of progress reports and client/study/network meeting materials.
• Assist with the preparation of site or investigator training materials; participate and/or assist with trainings for clinical study staff.
• Collaborate with data management team to develop and implement data collection and management strategies.
• Participate in quality control activities.
• Monitor risks and implement mitigation strategies.
• Gather background data and information to support proposal and project efforts.

What You'll Need

• Bachelor's Degree and 3 years of experience, Master's degree and 1 years of experience, or equivalent combination of education and experience.
• Must have strong knowledge of clinical trial drug development processes, clinical trial study design, study planning and management.
• Experience supporting clinical trial operations.
• Previous clinical site level trial management experience is a plus.
• Proficiency with MS Word, Outlook, PowerPoint, Excel.
• Demonstrated interest in health or clinical research.
• Ability to work in a highly collaborative environment.
• Ability to listen and communicate well both verbally and in writing.
• Ability to synthesize and summarize complex information.
• Ability to work independently.
• Attention to detail and accuracy.
• Ability to handle regular changes to priorities, interruptions to independent work due to meetings, and multiple tasks ongoing simultaneously.
• Ability to have regular, reliable and predictable attendance.

#LI-KV1

EEO & Pay Equity Statements

For San Francisco, CA USA Job Postings Only: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Further information is available here.

RTI accepts applications to our job openings from candidates with criminal histories or conviction records in accordance with all applicable laws, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

For Applicants in Massachusetts Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

The anticipated pay range for this role is listed below. Our pay ranges represent national averages and may vary by location as a geographic differential may be applied to some locations within the United States. RTI considers multiple factors when making an offer including, for example: established salary range, internal budget, business needs, and education and years of work experience possessed by the applicant. Further, salary is merely one element to our offer.

At RTI, we demonstrate our commitment to rewarding individual and team achievement through a total rewards package. This package includes (among other things) a competitive base salary, a generous paid time off policy, merit based annual increases, bonus opportunities and a robust recognition program. Other benefits include a competitive range of insurance plans (including health, dental, life, and short-term and long-term disability), access to a retirement savings program such as a 401(k) plan, paid parental leave for all parents, financial assistance with adoption expenses or infertility treatments, financial reimbursement for education and developmental opportunities, an employee assistance program, and numerous other offerings to support a healthy work-life balance.

Equal Pay Act Minimum/Range

$77,000 - $94,000