Job Description
Job Title: Clinical Study Manager
Location: 100% Remote, M-F 8a-5p CT
Type: 12 month contract
Pay Rate: $35-42.50hr.
Duties and Responsibilities:
Duties include but are not limited to:
- Ensure all contracted study deliverables/milestones are met within the expected timelines and quality level.
- Develop or supervise the development of all plans and tracking tools used for managing and reporting of study status; Provide study status reports, as needed.
- Oversee the study activation and start-up process, ensuring all start-up activities are in line with the Company central operations processes and are tracked and documented.
- Train or ensure the appropriate training of study teams on processes, compliance, ICH-GCP, Company Healthcare policy, and SOPs; Ensure all training is appropriately documented.
- Proactively work with study team members to track study activity, identify milestone completion, ensure study timelines are on target, identify risks, and identify out-of-scope activity.
- Work with program manager and other CSMs to globally track all studies and identify resource constraints and competing deliverables, milestones, and deadlines.
- Manage communications for all study stakeholders, both internal and external, serving as the central resource for all study communications.
- Manage meetings by scheduling, prepping internal study teams, aligning stakeholders, setting agendas, driving the meetings formally or delegating task when appropriate, taking meeting minutes, documenting action items, and distributing meeting minutes and action items accordingly.
- Ensure the electronic trial master files (eTMFs), eBinders, and/or study folders in a shared drive are set-up and maintained from study start to completion.
- Perform regular audits of eTMF documents, eBinder files, and/or study documents.
- Manage vendors and vendor contracts as needed; including amendments.
- Manage sponsors and sponsor contracts as needed; including amendments.
- Initiate improvements in tools, templates, and forms to enhance the efficiency and the quality of the work performed on assigned projects, as needed.
- Create a variety of reports, documents, training tools, and correspondence, as needed, to assist effective study conduct.
- Communicate and escalate unresolved issues at the appropriate time and to the appropriate level of management.
- Travel may be required, albeit limited for the CSM. Opportunities for travel include team-building sessions and attendance at conferences. Overnight stays and non-normal business hour activity may be required for this travel.
Competencies/Requirements:
- Minimum Education Required: Bachelor's Degree, Preferred Education: Master’s Degree
- Minimum Relevant Experience Required: At least two years of experience in clinical research as a CRC, CRA, study coordinator, data coordinator, or similar research/healthcare profession with translatable skills
- Preferred Relevant Experience: 2-3 years of experience as a Project Manager (PM) or Clinical Study Manager (CSM) within a Clinical Research Organization (CRO) or Sponsor Company; Alternatively, experience managing research projects in academia or within a Site Management Organization (SMO) will be considered.
- Knowledge of FDA guidelines and ICH-GCP is required
- Strong understanding of research conduct and project management
- Excellent professional writing and communication skills
- Strong computer skills with demonstrated ability using clinical trial databases, clinical trial management systems, electronic data capture, proficient in Microsoft Office software, including Project, Word and Excel, and ability to learn new software, if required.
- Excellent organizational and prioritizing capabilities
- Resourceful with heightened analytical abilities and problem-solving skills in a fast-paced environment
- Excellent interpersonal skills, detail-oriented and meticulous
- Proficiency at conflict resolution and making sound decisions under pressure, maintaining clarity and composure in high-stakes environments
- The physical demands described here are representative of those that must be met by a colleague to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Ability to read, write and speak English. Requires prolonged sitting, some bending, stooping and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment. Requires normal range of hearing and eye sight to record, prepare and communicate appropriate reports. Requires lifting papers or boxes up to 25 pounds occasionally. Work is performed in an office environment and involves frequent contact with staff and the public.
System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Ref: #568-Clinical
Job Tags
Contract work, Work at office, Local area, Remote work, Night shift,