Overview:
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.

Qualifications:

• 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

Responsibilities:

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.

Qualifications:

• 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.

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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.
Hiring Salary Range: $77,000 - $94,00