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Clinical Study Manager

Remote Clinical Study Manager: Assistant Clinical Study Manager (United States)

Are you a highly motivated, results-oriented clinical research professional? Indeed, RTI International (RTI), a global research institute, now actively seeks an Assistant Clinical Study Manager (Remote) to join our team in the United States. This is therefore a truly unique opportunity to contribute to science-based solutions that impact global well-being. Ultimately, you’ll find work you believe in, tackling some of the most complex global challenges of our time.

Why RTI?

RTI International is both a global research institute and a leading international development organization. Our mission, specifically, is to impact the well-being of 1 billion people by 2030. We achieve this, primarily, through science-based solutions in climate, education, health, and equity. Furthermore, our staff promote meaningful change worldwide, helping people live healthier, more productive, and more independent lives.

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

Remote Clinical Study Manager

About the Role: Assistant Clinical Study Manager

We are seeking an Assistant Clinical Study Manager (Asst. CSM) to join our operations team. The ideal candidate, first and foremost, will be highly motivated, results-oriented, and collaborative. Crucially, you’ll have experience working as an integral member of a multi-site clinical trial operations team and on related drug development initiatives.

As the Remote Clinical Study Manager, you’ll support the Lead CSM (operational lead) for clinical trials. Your tasks, therefore, will pertain to study planning, budget and resource management, and oversight of project vendors and subcontractors. Focused on operational excellence, you’ll work closely with both the Lead CSM and Project Leadership. This support, moreover, includes managing and coordinating a cross-functional study team. Consequently, you’ll 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: Key Deliverables

Your key deliverables in this Remote Clinical Study Manager role involve assisting and supporting the planning and execution of complex clinical trials. You’ll ensure adherence, accordingly, to designated timelines and budgets.

Project Management and Documentation:

• You’ll manage components of projects, under the direction of the Lead CSM.
• You’ll assist in the preparation and oversee distribution of study documents and materials. This, for example, includes data collection forms, manuals of operations, and technical memos to research sites.
• You’ll assemble and distribute various materials, including study supplies and data collection forms, to clinical sites.
• You’ll coordinate and schedule conference calls, then write and distribute meeting minutes.
• You’ll manage correspondence and project communications.

Reporting, Training, and Quality Control:

• You’ll assist in the preparation and updating of progress reports and client/study/network meeting materials.
• You’ll assist with the preparation of site or investigator training materials. You may, furthermore, also participate and/or assist with trainings for clinical study staff.
• You’ll collaborate with the data management team to develop and implement data collection and management strategies.
• You’ll participate in quality control activities.
• You’ll monitor risks and implement mitigation strategies.

Qualifications

Education:

• A Bachelor’s Degree and 3 years of experience is required.
• Alternatively, a Master’s degree and 1 year of experience, or an equivalent combination of education and experience, will be considered.

Experience and Skills:

The ideal Remote Clinical Study Manager candidate should possess the following:

Core Expertise:

• You must have strong knowledge of clinical trial drug development processes, clinical trial study design, study planning, and management.
• Furthermore, you need experience supporting clinical trial operations.
• Previous clinical site level trial management experience is a plus.

Technical and Professional Abilities:

• Proficiency with MS Word, Outlook, PowerPoint, and Excel is essential.
• You should demonstrate a clear interest in health or clinical research.
• Moreover, you must have the ability to work in a highly collaborative environment.
• You’ll need strong verbal and written communication skills.
• Crucially, you must be able to synthesize and summarize complex information.
• You must, in addition, demonstrate the ability to work independently.
• Attention to detail and accuracy are paramount.
• You should be able to handle regular changes to priorities, interruptions due to meetings, and multiple ongoing tasks simultaneously.
• Finally, regular, reliable, and predictable attendance is expected.

EEO & Pay Equity Statements

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.

California & Los Angeles County Applicants:

• RTI accepts applications 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.

Massachusetts Applicants 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, consequently, shall be subject to criminal penalties and civil liability.

Compensation and Benefits:

• The anticipated pay range for this Remote Clinical Study Manager role is $77,000 – $94,000.
• Our pay ranges, generally speaking, represent national averages and may vary by location, as geographic differentials may apply. RTI considers multiple factors when making an offer, including established salary range, internal budget, business needs, education, and years of work experience. Salary, ultimately, is merely one element of our offer.
• At RTI, we reward individual and team achievement through a comprehensive total rewards package. This includes a competitive base salary, a generous paid time off policy, merit-based annual increases, bonus opportunities, and a robust recognition program. Other benefits include competitive insurance plans (health, dental, life, short-term and long-term disability), a 401(k) plan, paid parental leave, financial assistance with adoption expenses or infertility treatments, financial reimbursement for education and development, an employee assistance program, and numerous other offerings to support work-life balance.
• Apply here: https://unjobs.org/vacancies/1753299152257

Frequently Asked Questions (FAQs) for the Remote Clinical Study Manager:

Q1: Is this truly a remote position? A1: Yes, this Assistant Clinical Study Manager role is fully remote within the United States.

Q2: What are the primary responsibilities of this role? A2: As a Remote Clinical Study Manager, you’ll primarily support the Lead CSM in planning and executing clinical trials. This also includes managing project components, overseeing documentation, and coordinating cross-functional teams.

Q3: Does this position involve staff management? A3: No, this position manages studies but does not have administrative management responsibilities for any staff.

Q4: What educational background is required? A4: A Bachelor’s Degree with 3 years of experience or a Master’s degree with 1 year of experience (or equivalent combination) is required.

Q5: What is the salary range for this position? A5: The anticipated pay range for this Remote Clinical Study Manager role is $77,000 – $94,000, which may vary by location.