Clinical Study Manager

Job Summary

The Study Manager is responsible for the overall management of the life of a clinical trial, overseeing the work of Study Coordinators and Clinical Research Nurses to ensure efficiency and success of the applicable trial.

Key Responsibilities

Team Leadership and Coordination

• Support and mentor clinical research coordinators in collaboration with the Clinical Site Manager.
• Provide training and ensure all staff is familiar with the study protocol, ethical guidelines, and safety requirements
• Partner with the RCR Leadership team for capacity planning and trial operations success
• Foster effective communication among all stakeholders

Clinical Responsibilitie

• Be the expert on assigned trials; understanding and implementing the protocol
• Create study timelines and execution planning (IP delivery, lab kits, etc)
• Involved in all study planning - monitor communications, attending IM SIV, approving source creation (paper and electronic)
• Act as the backup to the lead coordinator
• Serve as primary escalation and contact for resolution of issues that arise throughout trial for both internal and external teams

Regulatory Responsibilities

• Managing internal greenlight process - ensuring all training and delegations are appropriately signed and completed, collaborating with regulatory
• Maintain all appropriate documentation throughout the trial
• Ensure all billable items are captured correctly for study
• Work with QA to evaluate root-cause analysis of CAPA’s

Additional duties and projects as assigned

Qualifications

• Strong team leadership and management skills
• Strong verbal and written communication skills
• Strong interpersonal and customer service skills
• Strong organizational skills and attention to detail
• Strong time management skills with a proven ability to meet deadlines
• Strong analytical and problem-solving skills
• Ability to prioritize tasks and to delegate them when appropriate
• Ability to function well in a high-paced environment

Education and Experience

• Bachelor’s or associate degree in health or science related field required
• 3-5 years of experience in clinical research, with at least 2 years in a leadership role overseeing clinical studies or trials

Job Type: Full-time

Pay: $89,000.00 - $92,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Relocation assistance
• Vision insurance

Application Question(s):

• Will you now, or in the future, require sponsorship for employment visa status (e.g. H-1B visa status)?

Experience:

• Clinical research: 2 years (Required)

Location:

• Rochester, NY 14609 (Required)

Work Location: In person

Salary : $89,000 - $92,000